Data / Medical devices / Cushion, Flotation
Cushion, Flotation (KIC): 111 FDA-registered makers in 15 countries
111 establishments in 15 countries are registered with the FDA to make Cushion, Flotation (product code KIC, Class 1, 21 CFR 890.3175). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 29 510(k) clearances under this code, the latest on February 7, 1996, and lists 1 recall event (0 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
- KIC
- Device class
- 1
- Regulation
- 890.3175
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| China | 52 |
| United States | 28 |
| Taiwan | 8 |
| India | 5 |
| Mexico | 4 |
| United Kingdom | 3 |
| Poland | 2 |
| South Korea | 2 |
| Thailand | 1 |
| Canada | 1 |
| Dominican Republic | 1 |
| Germany | 1 |
| Japan | 1 |
| Spain | 1 |
| Indonesia | 1 |
Makers of Cushion, Flotation
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 |
|---|---|---|---|---|---|---|---|---|
| 3H Medical (thailand) Co., Ltd. | Nong Yai District Chon Buri, Thailand | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abletech Orthopedics Corporation | New Taipei City Taiwan, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Action Products, Inc. | Hagerstown, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Addto, Inc. | Elgin, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alimed, LLC | Dedham, MA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amylior, Inc. | Vaudreuil-Dorion Quebec, Canada | Complaint file establishment, 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 | |
| Anping Huakang Medical Products Factory | Hengshui Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Antar SP. J. | Warszawa Mazowieckie, Poland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AccuMed Corp. | Nigua San Cristobal, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Agiliti Health - Corona | Corona, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Agiliti Health - Ellis | Ellis, KS, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Airflo (Xiamen) Medical Co., Ltd. | Xiamen Fujian, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apex Medical (Kunshan) Corp. | Kunshan City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ArjoHuntleigh Polska Sp. zo.o. | Poznan Wielkopolskie, Poland | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Breg, Inc. | Carlsbad, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bort GmbH | WEINSTADT-BENZACH Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changsha Yuhong Trading Co., Ltd. | Changsha Hunan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chung Cheng Electric Heating Co., Ltd. | YUNG KANG CITY Tainan, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Comro Products, LLC | Dupo, IL, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carilex Medical, Inc. | Guishan District Taoyuan, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cascade Designs Nevada, Inc. | Reno, NV, United States | Manufacturer | 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 | |
| Dongguan Guisheng Foam Products Co., Ltd | Dongguan Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dielectrics, Inc. | Chicopee, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Direct Healthcare Group Limited (THE KIRTON HEALTHCARE GROUP LTD) | Caerphilly, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan China Effort Healthcare Products Co., Ltd. | Dongguan City Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan IMS (FE) Electro-Mechanical Co., Ltd. | Dongguan City Guangdong, China | Contract 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 | |
| EHOB (Shanghai) Medical Products Co. Ltd. | Pudong Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EHOB(JiaXing) Medical Product Co., LTD. | Jiaxing Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ehob, Inc. | Indianapolis, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flocast LLC. | Dolgeville, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fortune Company Ltd. | Huizhou Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan Feiyang Medical Equipment Co., Ltd. | Foshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Frontier Therapeutics Limited | Tredegar Blaenau Gwent, United Kingdom | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gcmedica Enterprise Ltd.(wuxi) | WUXI Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GF Health Products, Inc | Atlanta, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Good Horse Toys And Gifts Co.ltd | DONGGUAN Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Yazhi Technology Co., Ltd | Huizhou City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Yuehua Medical Instrument Factory Co., Ltd. | Shantou Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Queenhe Import & Export Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Dingli Medical Apparatus And Instrument Co., Ltd | HENGSHUI CITY Hebei, 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 | |
| Hefei Mlush Sanitary Products Co.,ltd | Hefei Anhui, 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 | |
| Hospital Equipment MFG. Co. | NOIDA Uttar Pradesh, India | 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 | |
| Iimed Medical Mexicana S. De R.L. De C.V. | Reynosa Tamaulipas, Mexico | Complaint file establishment, Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inmed (wuxi) Medical Device Co.,ltd | Wuxi Jiangsu, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Apson S.A de C.V | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu World Biotech Co., Ltd | nantong Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Yishun Medical Equipment Co., Ltd | Nantong Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| K2 Health Products | Brooklyn, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kaji Corporation | Nita-gun Shimane, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ki Mobility | Stevens Point, WI, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Libertech Corporation | HWASEONG-SI Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lingxian Dongsheng Textile Co., Ltd. | Dezhou Shandong, China | Manufacturer | 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 | |
| Maxhealth Corp. | Xizhi District, New Taipei City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Materials And Equipment Manufacturing, Well Lands Enterprise Co., Ltd. | Taichung City, Taiwan | Contract manufacturer, Exporter to the US, 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 | |
| Metacare Industrial Ltd | Guangzhou Guangdong, China | Contract manufacturer, Manufacturer | 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 | |
| Numotech, Inc. | Northridge, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orliman Slu | La Pobla de Vallbona Valencia(Province), Spain | Manufacturer | 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 | |
| P.C.P. Champion | Ripley, OH, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Poliuretanos, S.A. De C.V. | Toluca Mexico, Mexico | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Professional Specialties Co., Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prosys International Ltd | London London, City of, United Kingdom | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT Newlife Healthcare International | Kota Administrasi Jakarta Utara, Indonesia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Purple Innovation, LLC | Mc Donough, GA, United States | Contract manufacturer, 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 | |
| R&R Medical Corporation Ltd. | Sanchong District New Taipei, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ROHO, Inc. | Belleville, IL, United States | Complaint file establishment, Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Skil-Care Corp. | New Rochelle, NY, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Medical | Portage, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sunrise Medical (us) LLC | Fresno, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai EHOB Health Care Products Co., LTD. | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Gel King Technology Co., LTD | Qidong Jiangsu, China | 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 | |
| Shenzhen Dongjilian Medical Tech Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Lantise Technology Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shijiazhuang Yide Medical Device Manufacturing Co., Ltd. | Shijiazhuang City Hebei, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sunrise Medical (US) LLC | Mount Juliet, TN, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sunrise Medical Tecnologias, S.A. de CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Minhua Medical Equipment Co.,Ltd. | SuZhou Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 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 | |
| The Soule Co | Lutz, FL, United States | 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 | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tops Medical Articles Industries Nantong Inc | Qidong City Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Valentine Intl. Ltd. | Hsichih City, Taipei Hsien, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vinyl Technology, Inc. | Monrovia, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WCW,Inc | Manchester Center, VT, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wellell Inc. | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wenzhou Kangju Medical Instrument Co., Ltd. | Wenzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Beatlecare Electronic Technology Co., Ltd | Xiamen Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Senyang Co., Ltd | Xiamen Fujian, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Taotao Technology Co., Ltd. | Xiamen City Fujian, China | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yearstar Healthcare Technology Co.,ltd | JIANGYIN Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Young Won Medical Co., Ltd. | Ansan-si Gyeonggi, South Korea | 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 Anji Huabu Industrial Co., Ltd. | HUZHOU Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongshan First Medical Equipment Co., Ltd | Zhongshan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 7, 1996. 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.