Data / Medical devices / Pad, Heating, Powered
Pad, Heating, Powered (IRT): 220 FDA-registered makers in 19 countries
220 establishments in 19 countries are registered with the FDA to make Pad, Heating, Powered (product code IRT, Class 2, 21 CFR 890.5740). 4 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 42 510(k) clearances under this code, the latest on September 12, 2025, and lists 7 recall events (2 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- IRT
- Device class
- 2
- Regulation
- 890.5740
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| China | 130 |
| United States | 33 |
| South Korea | 12 |
| Taiwan | 12 |
| United Kingdom | 5 |
| India | 5 |
| Vietnam | 4 |
| Germany | 3 |
| Italy | 3 |
| Hong Kong | 2 |
| Canada | 2 |
| Cambodia | 2 |
| Thailand | 1 |
| France | 1 |
| Malaysia | 1 |
| Mexico | 1 |
| Indonesia | 1 |
| United Arab Emirates | 1 |
| Russia | 1 |
Makers of Pad, Heating, Powered
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Avacen, Inc. | Carlsbad, CA, United States | Manufacturer | 1 | August 15, 2014 | 0 | 0 | 0 | api.fda.gov |
| Mibetec GMBH | Sandersdorf-Brehna Saxony-Anhalt, Germany | Manufacturer | 1 | August 26, 2016 | 0 | 0 | 0 | api.fda.gov |
| R&L Co., Ltd | Gwangmyeong Gyeonggi, South Korea | Manufacturer | 1 | February 8, 2008 | 0 | 0 | 0 | api.fda.gov |
| Richway & Fuji Bio Inc. | Honolulu, HI, United States | Complaint file establishment, Specification developer | 1 | February 8, 2008 | 0 | 0 | 0 | api.fda.gov |
| 3H Co.,ltd | Dong-gu Daegu, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Advanced Healthcare Technology Limited | Waltham Cross Hertfordshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Airglove Medical Limited | East Kilbride South Lanarkshire, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amarigo Inc | Los Angeles, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amis (xiamen) Cultural Creativity Co., Ltd | Xiamen Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anhui Aerospace & Pma Health Tech. Co., Ltd | Hefei Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anodyne Therapy, LLC | Oldsmar, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aoj Health Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aopu Lighting (jinyun) Co., Ltd. | Lishui Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apothecaries Sundries MFG Pvt Ltd | GURUGRAM Haryana, India | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arlington Scientific, Inc. | Springville, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avita (wujiang) Co., Ltd | Wujiang City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avita Corp (thailand) Co., Ltd. | Chonburi Chon Buri, Thailand | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anhui Chuangnuo Medical equipment Co., LTD | Anqing City Anhui, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Babson Diagnostics | Austin, TX, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bear Down Brands, LLC | Fullerton, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Eternal Medical Technology Co.,ltd. | Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bluetex Health Technology Co.,ltd. | Shaoxing City Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BMS Co., Ltd. | Paju Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brace Align | Soddy Daisy, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Battle Creek Equipment | Fremont, IN, United States | Manufacturer, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Besmed Health Business Corporation | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BlephEx, LLC | Brentwood, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ceragem Co., Ltd. | Cheonan-si, Seobuk-gu Chungnam, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changsha Yuhong Trading Co., Ltd. | Changsha Hunan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cogmedix | West Boylston, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Conair LLC. | Stamford, CT, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dikaku Industrial Co.,limited | Hong Kong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Djo, LLC | Carlsbad, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dong Guan Jia Shuan Industrial Co., Ltd | Dongguan Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dong Guan Yunzhishang Health Technology Co.,ltd. | Dongguan City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Bao Kang Dian Zi Ke Ji Limited | Dongguan City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan City Sinoshine Technology Co.,ltd | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Heat Appliance Co.,ltd. | DongGuan City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Lide Electric Appliance Co., Ltd | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Ness Sports Technology Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Paidaxing Technology Co., Ltd | Dongguan City Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Quanding Medical Supplies Co., Ltd | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Redthera Technology Co., Ltd. | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Sainvie Health Technology Co.,ltd. | Dongguan Guangdong, China | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Taishin Electronic Co., Ltd. | Dongguang Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Xilijian Technology Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Xinjin Thermo Control Manufacturing Co., Ltd. | DONGGUAN CITY Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Yanxi Technology Co. Ltd. | Dongguan Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Yingfeng Metal & Plastic Products Co., Ltd | Dongguan Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Domico Med-Device, LLC | Fenton, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan DaMei Appliances Ltd. | Dongguan City Guangdong, China | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eagle Electric(shenzhen) Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Espansione Marketing SPA | FUNO Bologna, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Espansione Marketing SPA | CREVALCORE Bologna, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ezra Innovation (Dong guan) Limited | DongGuan City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan Zike Technology Co., Ltd. | Foshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gaboss International Limited | KOWLOON Xinjiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Generalnet Co., Ltd. | Gangnam-gu Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GHL Co., Ltd. | Namyangju-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gongqingcheng Multi Technology Health Care Inc. | GONGQINGCHENG Jiangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Green Energy Nano Technology Co., Ltd | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Greenwell Health Care (HK) Ltd | Tsuen Wan, Hong Kong | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Junfeng BFS Technology Co., Ltd. | guangzhou Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangxi Ulike Medical Technology Co., Ltd. | Yulin Guangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Fuerle Health Technology Co., Ltd | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Huakai Electronic Technology Co., Ltd. | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Xinbo Electronic Co., Ltd | guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Grahope New Materials Technologies Inc. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Okay Technology Co.,Ltd. | Zhong Shan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Huikang Electronic Technology Co., Ltd. | Guangzhou Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guinot | Dammarie les Lys Ile-de-France, France | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Zhengda Medical Co.,ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hanil Medical Co., Ltd. | Gwangju-si, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hefei Mlush Sanitary Products Co.,ltd | Hefei Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hengshui Gangsheng Medical Instruments Co., Ltd | Hengshui Hebei, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hi-Dow Electron Technology (hefei) Inc., Ltd | Hefei Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hivox Biotek Inc. | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Home Care Technology Co., Ltd. | Tainan City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hong Qiangxing (shen Zhen) Electronics Limited | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hue Light Co., Ltd | Gwangmyeong-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huizhou Hizorion Tech Co.,ltd | Huizhou Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hunan Jianyuan Medical Science And Technology Co.,ltd | Loudi Hunan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hyperice, Inc. | Irvine, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Wellbeing Technology Co., Ltd. | Hangzhou City Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heuer International (A division of GST Corporation Limited) | NOIDA Uttar Pradesh, India | Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hyundai Medical Co.,Ltd. | Yongin-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| I-Ming Sanitary Materials Co., Ltd. | Changhua, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intoborn Co., Ltd. | Gimhae-si Gyeongnam, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jandty Health Inc. | Taichung, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JC & A Canada Inc. | Oakville Ontario, Canada | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Alphay Medical Device Co., Ltd. | Nantong Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Fangxiangji Textile Technology Co.,ltd | yancheng Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Sintang Health&technology Co.,ltd | Yancheng Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangxi Mukang Electrical Applances Co, Ltd. | Ji'an Jiangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JKH Health Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jso Technology SDN.BHD. | KUALA LANGAT Selangor, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Just Keep Healthy Co., Ltd. | Samkkei Munichay District Kampong Speu, Cambodia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Yoosun Intelligent Technology Company Limited | Changshu Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kinreen Technology(shenzhen) Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KL Distributing | Hudson, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kamedi GmbH | Karlsruhe Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kaz USA, Inc., A Helen of Troy Company | Marlborough, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| King Brand Healthcare Products | Bellingham, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lianmaida Electric (dongguan) Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Liaoning Dikangyuan Health Technology Co.,ltd. | LIAOYANG Liaoning, China | Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Liaoyang Biolife Technology Co.,ltd | LIAOYANG Liaoning, China | Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Linjiang (holdings) Limited | Shangqiu Henan, China | Foreign private label distributor, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M/S. Ascent Meditech Limited | GOREGAON (E) Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merchsource LLC | Irvine, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microlife Corp. | Taipei, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Miller Technical Services | Plymouth, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Bellavie Electric Appliance Co.,ltd | Ningbo Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Just Soon Industrial Limited | Ningbo Zhejiang, China | Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Unico Products Co., Ltd | Ningbo Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Normatec Industries, LP | Watertown, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Novem Medical S. De R.L. De C.V. | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nuga Medical Co Ltd | Wonju Gangwon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Netop Industrial Company Limited | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo JustLive Electrical Appliance Co., Ltd | Ningbo Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Quanxiao Health Technology Co., Ltd | Ningbo Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Royal Peace Household Products Co., Ltd. | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nureca Technologies Private Limited | Mohali Punjab, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| OCuSOFT LLC | Rosenberg, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ogawa Wellness Vietnam Company Limited | Long An, Vietnam | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthocor Medical Inc. | Blaine, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| OcuSci Inc. | Del Mar, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Panasonic Manufacturing Uk Ltd. | Cardiff Wales, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pixie Cup LLC | Walnut Shade, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plexaa Ltd | London London, City of, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Power Well Healthcare Technology Co., Ltd. | Changhua County, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Praywise Technology (dongguan) Co., Ltd | Dongguan City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT. Beurer Indonesia Technology | Kab Kendal Jawa Tengah, Indonesia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| QuantMed LifeTech (Shenzhen) Co., Ltd. | ShenzhenCity Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rechar Inc. | Strasburg, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Robotic Precision Therapy, LLC | Troy, MI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rog Sports Medicine, Inc. | Orland Park, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ryder Electronics (xinfeng) Ltd. | Ganzhou City Jiangxi, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| San Yang Electric Co., Ltd. | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SBM Sistemi SRL | Rivalta di Torino, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Bing Fan Industrial Co.,ltd. | Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai GK Industrial Co.,ltd. | Shanghai, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sharkninja Operating LLC | Needham, MA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Auraluxe Medical Equipment Co.,ltd | ShenZhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Baichang Technology Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer, Foreign private label distributor, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Caidisen Optoelectronics Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Combei Technology Co.,ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Ctlite Technology Co.,ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Future Electronic Co.,ltd | SHENZHEN Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen H&T Intelligent Control Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Hengbosi Industrial Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Huayu Wantuo Technology Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Jimei Technology Development Co.,ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Meihui Optoelectronics Co., Ltd | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Micro Electric Intelligence Co., Ltd. | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Nuon Medical Equipment Co., Ltd. | ShenZhen Guangdong, China | Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Obestec Industrial Co.,ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Ruiyi Business Technology Co., Ltd. | Shenzhen Guangdong, China | Exporter to the US, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Sungrow Led Technology Co.,ltd | shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Tohachi Industrial Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Wanlong Technology Co., Ltd. | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Xiangzhida Technology Co.,ltd. | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhenshi Hengmeite Technology Co., Ltd. | Shen zhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shian Jia Meei Enterprise Co., Ltd. | Tainan Hsien, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shijiazhuang Wangfeng Technology Co.,ltd | Shijiazhuang Hebei, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sinoshine Health Technology Co., Ltd | Tan Uyen City Binh Duong, Vietnam | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| South Source Health Technology (cambodia) Co., Ltd. | Koh Kong, Cambodia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sunbeam Products, Inc. | Atlanta, GA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sungrow Technology Co.,limited | Hong Kong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgymed Trading Fze | Dubai Dubayy, United Arab Emirates | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Caiyang Electric Warmer Technologies Co., Ltd | Suzhou Jiangsu, China | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Care Us Medical Product Co., Ltd. | Shanghai, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Jie Zhong Lian Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Junneeled Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen OSTO Medical Technology Company Limited | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen RedV Medical Equipment Co., Ltd. | shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Suyzeko Limited | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Weirui Technology Co., Ltd. | Shenzhen Guangdong, China | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Yicai Health Technology Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sheyang Haoyueli Jade Products Co., Ltd | yancheng Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Jeno Dream Home Technology Co., Ltd | Changshu Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Taizhou Yunkai Tech Co Ltd | TAIZHOU Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TF New Material Sci And Tec Co.,ltd | Huainan Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thermotex Therapy Systems Ltd. | CALGARY Alberta, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thermotraumaport Limited | Ashford Kent, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tianjin Fuqin Science & Technology Corp., Ltd. | Nankai district Tianjin, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Top Longmax Products Co., Ltd. | Taichung, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Top-Tek Technology (vietnam) Company Limited | Thu Dau Mot Binh Duong, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Touchbeauty Beauty & Health (shenzhen) Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TVP Developments Ltd | Kowloon, Hong Kong | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tynor Orthotics (P) Ltd. | Mohali Punjab, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Therabody, Inc. | Los Angeles, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| U.S. Surgitech, Inc. | Carol Stream, IL, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Utk Technology Shen Zhen Limited | huizhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vietnam Heidacare Appliance Co., Ltd | Bac Ninh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Visuscience Meditech Co., Ltd. | WUXI Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vitori Health (liaoyang) Co.,ltd. | Liaoyang Liaoning, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WEERO Co., Ltd. | Suwon-si,Gyeonggi-do, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wenzhou Lingfeng Electronic Technology Co., Ltd | Ruian Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wenzhou Puyi Electric Appliance Co., Ltd. | wenzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wenzhou Ruisheng Electronic Science & Technology Co., Ltd. | Wenzhou City Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Well-Life Healthcare Limited | Jhonghe Taipei, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuhu OWFine Electronic Technology Co., Ltd. | Wuhu Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| X-CEN-TEK GmbH & Co. KG | Wardenburg Lower Saxony, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Comfort Science & Technology Group Co., Ltd. | Xiamen Fujian, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Ubest Electronic Technology Co., Ltd | Xiameng Fujian, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yelatma Instrument-Making Enterprise | Ryazan Ryazanskaya Oblast', Russia | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhangzhou Easepal Innovation Co.,ltd | Zhangzhou Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhangzhou Easepal Medical Science And Technology Co.,ltd. | zhangzhou Fujian, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhe Jiang Cleisman Industry And Trade Co.,ltd | Lishui Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Dingda Industrial Co.,ltd | Lishui Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang E-Cozy Electronic Technology Co., Ltd. | Wenzhou Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Longyou Landmedical Technology Co.,ltd. | longyou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Lumeng Health & Technology Co.,ltd Shao Xing Pao Jiang Branch | Shaoxing Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Shuoqi Home Textile Products Co., Ltd | Yuyao Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Sorbo Technology Co., Ltd. | Wenzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhengzhou Henghao Optical Technology Co. Ltd. | Zhengzhou Henan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongshan GL Electronics Co.,ltd | ZHONGSHAN Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongshan Meiyigou Electronics Co.,ltd | Zhongshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Yueda Electronic Technology Co., Ltd. | Ningbo Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 12, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.