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Data / Medical devices / Unit, Heating, Powered

Unit, Heating, Powered (IRQ): 43 FDA-registered makers in 11 countries

43 establishments in 11 countries are registered with the FDA to make Unit, Heating, Powered (product code IRQ, Class 1, 21 CFR 890.5950). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on September 14, 2005, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code
IRQ
Device class
1
Regulation
890.5950
Medical specialty
Physical Medicine

Makers by country

CountryMakers
China17
United States9
South Korea4
Germany3
Mexico3
Hong Kong2
Canada1
Finland1
Brazil1
United Kingdom1
Taiwan1

Makers of Unit, 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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Biomet MicrofixationJacksonville, FL, United StatesRepackager or relabeler, Specification developer0010api.fda.gov
Compass Health Brands (corporate Office)Middleburg Heights, OH, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Core Products International IncChetek, WI, United StatesManufacturer0000api.fda.gov
Disk DR. Co., Ltd.Hanam-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
DJ Orthopedics De Mexico, S.A. De C.V.TIJUANA Baja California, MexicoManufacturer0000api.fda.gov
Djo, LLCCarlsbad, CA, United StatesSpecification developer0000api.fda.gov
Dongguan Quanding Medical Supplies Co., LtdDongguan Guangdong, ChinaManufacturer0000api.fda.gov
Dongguan Tutamen Metalwork Co.,LTD.Dongguan Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Equipro Equipements D'Esthetique Inc.Montreal Quebec, CanadaManufacturer0000api.fda.gov
Grahope New Materials Technologies Inc.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Hanil Medical Co., Ltd.Gwangju-si, South KoreaManufacturer0000api.fda.gov
HEALING T.F.K Co., Ltd.Chilgok-gun Gyeongbuk, South KoreaManufacturer0000api.fda.gov
Health Body World Supply, Inc. Dba The Wabbo CompanyLake Elsinore, CA, United StatesSpecification developer0000api.fda.gov
Hebei Mita Biotechnology LimitedHong Kong, Hong KongManufacturer0000api.fda.gov
Hefei Morningstar Healthmate Fitness Co.,ltdHefei Anhui, ChinaManufacturer0000api.fda.gov
Inion OYTAMPERE Pirkanmaa, FinlandManufacturer, Specification developer0000api.fda.gov
Ibramed Industria Brasileira de Equipamentos Medicos LtdaAmparo Sao Paulo, BrazilManufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Jiangsu Moen Industrial Co.,ltdSuqian Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Karis Co., Ltd.Gimpo-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
KLS Martin SE & Co. KGMuhlheim/Donau Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
KLS-Martin L.P.Jacksonville, FL, United StatesSpecification developer0000api.fda.gov
Linjiang (holdings) LimitedShangqiu Henan, ChinaManufacturer0000api.fda.gov
Marturion Electronics LtdLisburn Northern Ireland, United KingdomContract manufacturer0000api.fda.gov
Mibo Medical GroupIrving, TX, United StatesManufacturer0000api.fda.gov
Oman Medical Beauty Manufacture LimitedHong Kong, Hong KongManufacturer0000api.fda.gov
Onlycare IncDenver, CO, United StatesManufacturer0000api.fda.gov
Picard Healthcare Technology (Dongguan) Co. LtdDongguan Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Eyco Technology Co.,ltdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Joose Beauty Electronic Co.,ltdShen Zhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer, Remanufacturer0000api.fda.gov
Shenzhen Obestec Industrial Co.,ltdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Shengbanghua Technology Development Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Youmay Electronics Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Stryker Leibinger GMBH & Co. KGFREIBURG Baden-Wurttemberg, GermanyComplaint file establishment, Specification developer0000api.fda.gov
Suzhou Jeno Dream Home Technology Co., LtdChangshu Jiangsu, ChinaManufacturer0000api.fda.gov
Tutamen De Mexico, LLCTijuana Baja California, MexicoManufacturer0000api.fda.gov
Tianjin Zhengtian Medical Instrument Co., Ltd.Tianjin, ChinaContract manufacturer0000api.fda.gov
VADI Medical Technology Co., Ltd.Taoyuan City, TaiwanManufacturer0000api.fda.gov
Zhongshan Kingdom Electrical Appliance Co., Ltd.Zhongshan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhongshan Todom Electrical Appliance Co., LtdZhongshan Guangdong, ChinaManufacturer0000api.fda.gov
Zhongshan Bisen Plastic Electronic Products Co.,LtdZhongshan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov

Updated September 14, 2005. 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.