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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.

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Product code
KIC
Device class
1
Regulation
890.3175
Medical specialty
Physical Medicine

Makers by country

CountryMakers
China52
United States28
Taiwan8
India5
Mexico4
United Kingdom3
Poland2
South Korea2
Thailand1
Canada1
Dominican Republic1
Germany1
Japan1
Spain1
Indonesia1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
3H Medical (thailand) Co., Ltd.Nong Yai District Chon Buri, ThailandManufacturer0000api.fda.gov
Abletech Orthopedics CorporationNew Taipei City Taiwan, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Action Products, Inc.Hagerstown, MD, United StatesManufacturer0000api.fda.gov
Addto, Inc.Elgin, IL, United StatesSpecification developer0000api.fda.gov
Alimed, LLCDedham, MA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Amylior, Inc.Vaudreuil-Dorion Quebec, CanadaComplaint file establishment, Specification developer0000api.fda.gov
Anping Guardian Medical Equipment Co.,ltdHengshui Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Anping Huakang Medical Products FactoryHengshui Hebei, ChinaManufacturer0000api.fda.gov
Antar SP. J.Warszawa Mazowieckie, PolandManufacturer0000api.fda.gov
AccuMed Corp.Nigua San Cristobal, Dominican RepublicContract manufacturer0000api.fda.gov
Agiliti Health - CoronaCorona, CA, United StatesManufacturer0000api.fda.gov
Agiliti Health - EllisEllis, KS, United StatesManufacturer0000api.fda.gov
Airflo (Xiamen) Medical Co., Ltd.Xiamen Fujian, ChinaExporter to the US, Manufacturer0000api.fda.gov
Apex Medical (Kunshan) Corp.Kunshan City Jiangsu, ChinaManufacturer0000api.fda.gov
ArjoHuntleigh Polska Sp. zo.o.Poznan Wielkopolskie, PolandComplaint file establishment, Specification developer0000api.fda.gov
Breg, Inc.Carlsbad, CA, United StatesSpecification developer0000api.fda.gov
Bort GmbHWEINSTADT-BENZACH Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Changsha Yuhong Trading Co., Ltd.Changsha Hunan, ChinaManufacturer0000api.fda.gov
Chung Cheng Electric Heating Co., Ltd.YUNG KANG CITY Tainan, TaiwanManufacturer0000api.fda.gov
Comro Products, LLCDupo, IL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Carilex Medical, Inc.Guishan District Taoyuan, TaiwanManufacturer0000api.fda.gov
Cascade Designs Nevada, Inc.Reno, NV, United StatesManufacturer0000api.fda.gov
Dong Guan Jia Shuan Industrial Co., LtdDongguan Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Dongguan Guisheng Foam Products Co., LtdDongguan Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Dielectrics, Inc.Chicopee, MA, United StatesContract manufacturer0000api.fda.gov
Direct Healthcare Group Limited (THE KIRTON HEALTHCARE GROUP LTD)Caerphilly, United KingdomManufacturer0000api.fda.gov
Dongguan China Effort Healthcare Products Co., Ltd.Dongguan City Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Dongguan IMS (FE) Electro-Mechanical Co., Ltd.Dongguan City Guangdong, ChinaContract manufacturer0000api.fda.gov
E-Life International Co., LtdYonghe Dist., Taipei, TaiwanExporter to the US, Manufacturer0000api.fda.gov
EHOB (Shanghai) Medical Products Co. Ltd.Pudong Shanghai, ChinaContract manufacturer0000api.fda.gov
EHOB(JiaXing) Medical Product Co., LTD.Jiaxing Zhejiang, ChinaContract manufacturer0000api.fda.gov
Ehob, Inc.Indianapolis, IN, United StatesManufacturer0000api.fda.gov
Flocast LLC.Dolgeville, NY, United StatesManufacturer0000api.fda.gov
Fortune Company Ltd.Huizhou Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Foshan Feiyang Medical Equipment Co., Ltd.Foshan Guangdong, ChinaManufacturer0000api.fda.gov
Frontier Therapeutics LimitedTredegar Blaenau Gwent, United KingdomComplaint file establishment, Manufacturer0000api.fda.gov
Gcmedica Enterprise Ltd.(wuxi)WUXI Jiangsu, ChinaContract manufacturer0000api.fda.gov
GF Health Products, IncAtlanta, GA, United StatesManufacturer0000api.fda.gov
Good Horse Toys And Gifts Co.ltdDONGGUAN Guangdong, ChinaContract manufacturer0000api.fda.gov
Guangdong Yazhi Technology Co., LtdHuizhou City Guangdong, ChinaManufacturer0000api.fda.gov
Guangdong Yuehua Medical Instrument Factory Co., Ltd.Shantou Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Hangzhou Queenhe Import & Export Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Hebei Dingli Medical Apparatus And Instrument Co., LtdHENGSHUI CITY Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hebei Youjie Medical Devices Co., LtdShijiazhuang Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hefei Mlush Sanitary Products Co.,ltdHefei Anhui, ChinaManufacturer0000api.fda.gov
Hengshui Runde Medical Instruments Co.,ltdHengshui City Hebei, ChinaManufacturer0000api.fda.gov
Hospital Equipment MFG. Co.NOIDA Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Hengshui Jingkang Medical Device Co.,Ltd.Hengshui City Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Heuer International (A division of GST Corporation Limited)NOIDA Uttar Pradesh, IndiaForeign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Iimed Medical Mexicana S. De R.L. De C.V.Reynosa Tamaulipas, MexicoComplaint file establishment, Contract manufacturer0000api.fda.gov
Inmed (wuxi) Medical Device Co.,ltdWuxi Jiangsu, ChinaExporter to the US, Specification developer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Jiangsu World Biotech Co., Ltdnantong Jiangsu, ChinaManufacturer0000api.fda.gov
Jiangsu Yishun Medical Equipment Co., LtdNantong Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
K2 Health ProductsBrooklyn, NY, United StatesSpecification developer0000api.fda.gov
Kaji CorporationNita-gun Shimane, JapanManufacturer0000api.fda.gov
Ki MobilityStevens Point, WI, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Libertech CorporationHWASEONG-SI Gyeonggi, South KoreaManufacturer0000api.fda.gov
Lingxian Dongsheng Textile Co., Ltd.Dezhou Shandong, ChinaManufacturer0000api.fda.gov
Liven Sports MFG. (xiamen) Co., Ltd.XIAMEN Fujian, ChinaManufacturer0000api.fda.gov
Lords Mark Industries Ltd.Daman and Diu Dadra and Nagar Haveli, IndiaManufacturer0000api.fda.gov
M/S. Ascent Meditech LimitedGOREGAON (E) Maharashtra, IndiaManufacturer0000api.fda.gov
Maxhealth Corp.Xizhi District, New Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Medical Materials And Equipment Manufacturing, Well Lands Enterprise Co., Ltd.Taichung City, TaiwanContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Metacare Industrial LtdGuangzhou Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Ningbo Unico Products Co., LtdNingbo Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Numotech, Inc.Northridge, CA, United StatesSpecification developer0000api.fda.gov
Orliman SluLa Pobla de Vallbona Valencia(Province), SpainManufacturer0000api.fda.gov
Orthotech Rehabilitation Co., Ltd.Xiamen Fujian, ChinaExporter to the US, Manufacturer0000api.fda.gov
P.C.P. ChampionRipley, OH, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Poliuretanos, S.A. De C.V.Toluca Mexico, MexicoContract manufacturer, Manufacturer0000api.fda.gov
Professional Specialties Co., Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Prosys International LtdLondon London, City of, United KingdomExporter to the US, Specification developer0000api.fda.gov
PT Newlife Healthcare InternationalKota Administrasi Jakarta Utara, IndonesiaManufacturer0000api.fda.gov
Purple Innovation, LLCMc Donough, GA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Picard Healthcare Technology (Dongguan) Co. LtdDongguan Guangdong, ChinaManufacturer0000api.fda.gov
R&R Medical Corporation Ltd.Sanchong District New Taipei, TaiwanManufacturer0000api.fda.gov
ROHO, Inc.Belleville, IL, United StatesComplaint file establishment, Manufacturer0010api.fda.gov
Skil-Care Corp.New Rochelle, NY, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Stryker MedicalPortage, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Sunrise Medical (us) LLCFresno, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Shanghai EHOB Health Care Products Co., LTD.Shanghai, ChinaContract manufacturer0000api.fda.gov
Shanghai Gel King Technology Co., LTDQidong Jiangsu, ChinaManufacturer0000api.fda.gov
Shanghai Leison Medical & Healthcare Products Co., LtdShanghai, ChinaManufacturer0000api.fda.gov
Shenzhen Dongjilian Medical Tech Co., LtdShenzhen Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shenzhen Lantise Technology Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer, Remanufacturer0000api.fda.gov
Shijiazhuang Yide Medical Device Manufacturing Co., Ltd.Shijiazhuang City Hebei, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Sunrise Medical (US) LLCMount Juliet, TN, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Sunrise Medical Tecnologias, S.A. de CVTijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Suzhou Minhua Medical Equipment Co.,Ltd.SuZhou Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
TF New Material Sci And Tec Co.,ltdHuainan Anhui, ChinaManufacturer0000api.fda.gov
The Soule CoLutz, FL, United StatesManufacturer0000api.fda.gov
Tuper Medical Co., Ltd.Dezhou City Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Tynor Orthotics (P) Ltd.Mohali Punjab, IndiaManufacturer0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Tops Medical Articles Industries Nantong IncQidong City Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Valentine Intl. Ltd.Hsichih City, Taipei Hsien, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Vinyl Technology, Inc.Monrovia, CA, United StatesContract manufacturer0000api.fda.gov
WCW,IncManchester Center, VT, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Wellell Inc.New Taipei City, TaiwanManufacturer0000api.fda.gov
Wenzhou Kangju Medical Instrument Co., Ltd.Wenzhou Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Xiamen Beatlecare Electronic Technology Co., LtdXiamen Fujian, ChinaManufacturer0000api.fda.gov
Xiamen Senyang Co., LtdXiamen Fujian, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Xiamen Taotao Technology Co., Ltd.Xiamen City Fujian, ChinaManufacturer, Specification developer0000api.fda.gov
Yearstar Healthcare Technology Co.,ltdJIANGYIN Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Young Won Medical Co., Ltd.Ansan-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Zhangpu Ortholife Rehabilitation Co., LtdZhangzhou Fujian, ChinaManufacturer0000api.fda.gov
Zhangzhou Recaring Medical Instrument Co., LtdZhangzhou Fujian, ChinaManufacturer0000api.fda.gov
Zhejiang Anji Huabu Industrial Co., Ltd.HUZHOU Zhejiang, ChinaManufacturer0000api.fda.gov
Zhongshan First Medical Equipment Co., LtdZhongshan Guangdong, ChinaExporter to the US, Manufacturer0000api.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.