Data / Medical devices / Band Or Belt, Pelvic Support
Band Or Belt, Pelvic Support (ISR): 121 FDA-registered makers in 15 countries
121 establishments in 15 countries are registered with the FDA to make Band Or Belt, Pelvic Support (product code ISR, Class 1, 21 CFR 890.3025). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on February 8, 1979, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- ISR
- Device class
- 1
- Regulation
- 890.3025
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| China | 52 |
| United States | 29 |
| Taiwan | 15 |
| India | 7 |
| Mexico | 5 |
| Canada | 3 |
| Germany | 2 |
| Dominican Republic | 1 |
| Cambodia | 1 |
| South Korea | 1 |
| Vietnam | 1 |
| Hong Kong | 1 |
| France | 1 |
| Egypt | 1 |
| Latvia | 1 |
Makers of Band Or Belt, Pelvic Support
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 |
|---|---|---|---|---|---|---|---|---|
| Abletech Orthopedics Corporation | New Taipei City Taiwan, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aid United International Co., Limited | Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Air A Med, LLC | Fort Myers, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Airway Surgical Appliances Ltd. | NEPEAN Ontario, Canada | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allmay Bodywear (shenzhen) Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anji Huifeng Surgical Dressings Co., Ltd. | ANJI COUNTY Zhejiang, China | Contract manufacturer, Contract sterilizer, Exporter to the US, Foreign private label distributor, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anping Guardian Medical Equipment Co.,ltd | Hengshui Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apothecaries Sundries MFG Pvt Ltd | GURUGRAM Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AccuMed Corp. | Nigua San Cristobal, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alphapointe | Jamaica, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Altimate Medical, Inc. | Frankfort, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BMS Great Lakes LLC | Kissimmee, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Border Opportunity Saver Systems, Inc. | Del Rio, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brace Align | Soddy Daisy, TN, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Braceability, Inc. | Cedar Falls, IA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BSN Medical S.A. de C.V. | Reynosa Tamaulipas, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BSN medical Inc. | Charlotte, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beocare Inc., Hudson | Hudson, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Comfy Health Group Co., Ltd. | Taipei, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Concarey Medical Technology Co., Ltd | Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Docbrace (cambodia) Co., Ltd | Phnom Penh Capital, Cambodia | Contract manufacturer, 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 Ness Sports Technology Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Supercare Medical Products Co., Ltd | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Du-Hope International Group | NANJING Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan China Effort Healthcare Products Co., Ltd. | Dongguan City Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| E-Life International Co., Ltd | Yonghe Dist., Taipei, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Electro Medical Equipment Co., Inc. | Prairieville, LA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Emsrun Group | Wuxi Jiangsu, China | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fenghua Tealmed Emergency Products Co.,ltd. | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fillauer, LLC | Chattanooga, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan Leawell Medical Technology Co.,ltd | FOSHAN Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FridaBaby LLC | Miami, FL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Generalnet Co., Ltd. | Gangnam-gu Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ghi Fu Technology Co., Ltd. | Changhua, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Global TV Concepts, Ltd. | Coconut Creek, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Greens Surgicals Private Limited | Vadodara Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Greatch Technology (Hebei) Co.,Ltd | Hengshui City Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Yifangjia Textile And Garment Technology Co., Ltd. | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hameco Hy Co., Ltd | Hung Yen Province, Vietnam | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Weize Imp & Exp Co., Ltd | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Zhongzhi Industry Co.,ltd | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Youjie Medical Devices Co., Ltd | Shijiazhuang Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hengshui Gangsheng Medical Instruments Co., Ltd | Hengshui Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hengshui Runde Medical Instruments Co.,ltd | Hengshui City Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hengshui Tianjian Medical Supplies Co., Ltd. | ShenZhou City Hebei, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hipsaver Inc. | Canton, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huntex Corporation | Taipei, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hengshui Jingkang Medical Device Co.,Ltd. | Hengshui City Hebei, China | 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 | |
| I-Ming Sanitary Materials Co., Ltd. | Changhua, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovance Textiles Limited | Hong Kong, Hong Kong | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Irufa Industrial Group Co., Ltd. | Tainan City, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Senolo Medical Technology Co., Ltd. | Yancheng Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Senwo Medical Technology Co., Ltd. | Nantong Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangxi Handasen Industry Co., Ltd | Shangrao Jiangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiundar Industrial Co., Ltd. | SHULIN CITY Taipei, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Juneng Sports Goods Technology Co., Ltd | Yangzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kerma Medical Products, Inc. | Suffolk, VA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| L&R Usa Inc. | Milwaukee, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| La Pointique International Ltd. | Seattle, WA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Liven Sports MFG. (xiamen) Co., Ltd. | XIAMEN Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lords Mark Industries Ltd. | Daman and Diu Dadra and Nagar Haveli, India | 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 | |
| Magway Trading Inc. | Markham Ontario, Canada | Foreign private label distributor, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Majesty-Tech Product Development Corp. | Taipei City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maquiladora De Coahuila S De RL De CV | CUIDAD ACUNA Coahuila, Mexico | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Z, S.A. | SAINT AVERTIN Indre-et-Loire, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtech Acuna S.A. De C.V. | Acuna Coahuila, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Miracle Medical Industries | El Obour City Al Qahirah, Egypt | Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mueller Sports Medicine, Inc. | Prairie Du Sac, WI, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Narang Medical, Ltd. | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo MPF Manufacturing Co.,ltd. | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NYOrtho | Brooklyn, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| O&M Halyard, Inc. | Alpharetta, GA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oppo Medical, Inc. | Seattle, WA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthotech Rehabilitation Co., Ltd. | Xiamen Fujian, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH | DUDERSTADT Lower Saxony, Germany | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plus Meditech Co., Ltd. Plant 2 | Tainan City, Taiwan | Exporter to the US, 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 | |
| Professional Products, Inc. | Defuniak Spgs, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Picard Healthcare Technology (Dongguan) Co. Ltd | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richardson Products, Inc. | Frankfort, IL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| SEI Medical S.A. de C.V. | Juarez Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Tohachi Industrial Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shijiazhuang Runyi Medical Device Technology Co.,ltd. | Shijiazhuang Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sia Tonus Elast / Tonus Elast LLC. | Grinvalti,Nicas pag Nicas Novads, Latvia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Span Link International LLC | Deer Park, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Special Protectors Co., Ltd. | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STREIFENEDER ortho.production gmbH | EMMERING Bavaria, Germany | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Sunmed Co., Ltd | SUZHOU CITY Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Serola Biomechanics, Inc. | Loves Park, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Leison Medical & Healthcare Products Co., Ltd | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shijiazhuang Aofeite Medical Device Co.,Ltd | Shijiazhuang Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shock Doctor, Inc. | Costa Mesa, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ta Lai Sporting Goods Enterprises Co. Ltd. | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Ergo Baby Carrier, Inc. | Concord, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tiburon Medical Enterprises | San Jacinto, CA, United States | 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 Medical Corp. | Chung Li City Taoyuan, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trulife Limited | TRENTON Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tuper Medical Co., Ltd. | Dezhou City Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tynor Orthotics (P) Ltd. | Mohali Punjab, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Weihai Dishang Medical Technology Co.,ltd | Weihai Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Welkong Sports Industrial Co.,ltd | Dongguan city Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Welltex Sports Co., Ltd. | Taipei City, Taiwan | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Huakang Orthopedic Co.,ltd | Xiamen City Fujian, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen J-Brace Medical Equipment Co., Ltd. | Xiamen Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Aolikes Sports Goods Co., Ltd. | Yangzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Jindu Sporting Goods Co., Ltd. | Yangzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Juli Sports Articles Co.,ltd. | YangZhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Qiangjing Sports Products Co.,ltd | Yangzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Sensport Healthcare Supplies Co., Ltd. | Yangzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhangpu Ortholife Rehabilitation Co., Ltd | Zhangzhou Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhangzhou Recaring Medical Instrument Co., Ltd | Zhangzhou Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Luyao Electronics Technology Co.,ltd | Wenzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan City, Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zeffer Research & Assoc. S. A. de C. V. | Ensenada Baja California, Mexico | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Rehan Medical Manufacturing Co., Ltd. | Jiaxing City Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Steriger Sports Medicine Technology Co.,Ltd | Yiwu Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 8, 1979. 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.