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Data / Medical devices / Hand, External Limb Component, Powered

Hand, External Limb Component, Powered (IQZ): 31 FDA-registered makers in 14 countries

31 establishments in 14 countries are registered with the FDA to make Hand, External Limb Component, Powered (product code IQZ, Class 1, 21 CFR 890.3420). 0 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 2 recall events (1 Class I). FDA data exported November 2, 2026.

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Product code
IQZ
Device class
1
Regulation
890.3420
Medical specialty
Physical Medicine

Makers by country

CountryMakers
United States9
China6
United Kingdom4
Poland2
Italy1
Sweden1
Ukraine1
Canada1
South Korea1
Iceland1
Austria1
New Zealand1
Taiwan1
Germany1

Makers of Hand, External Limb Component, 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
Aether Biomedical SP. Z O.O.Poznan Wielkopolskie, PolandComplaint file establishment, Manufacturer0000api.fda.gov
Aid United International Co., LimitedShanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Alt-Bionics, Inc.San Antonio, TX, United StatesManufacturer0000api.fda.gov
Bionit Labs S.R.L.Soleto Lecce, ItalyComplaint file establishment, Manufacturer0000api.fda.gov
Bioservo ABKista Stockholm, SwedenComplaint file establishment, Manufacturer0000api.fda.gov
Covvi Usa, IncSan Antonio, TX, United StatesManufacturer0000api.fda.gov
Coapt LLCChicago, IL, United StatesComplaint file establishment, Manufacturer, Remanufacturer0000api.fda.gov
Covvi Ltd.Leeds West Berkshire, United KingdomManufacturer0000api.fda.gov
Esper LLC.Kyiv Kyyiv, Misto, UkraineManufacturer0000api.fda.gov
Fortune Company Ltd.Huizhou Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Foshan Hongfeng Co.,ltdFoshan Guangdong, ChinaManufacturer0000api.fda.gov
Hugh Steeper LtdLeeds, England, United KingdomComplaint file establishment, Manufacturer, Remanufacturer0000api.fda.gov
Hugh Steeper Ltd DBA SteeperUSAHopkinton, MA, United StatesComplaint file establishment, Remanufacturer0000api.fda.gov
Infinite Biomedical Technologies, LLCBaltimore, MD, United StatesManufacturer0000api.fda.gov
KinovaBoisbriand Quebec, CanadaManufacturer0011api.fda.gov
Medex Medical Supplies Ltd.China Guangdong, ChinaManufacturer0000api.fda.gov
Motion Control, Inc.Salt Lake City, UT, United StatesManufacturer0010api.fda.gov
Myomo, Inc.Burlington, MA, United StatesManufacturer0000api.fda.gov
Mand.ro Co., Ltd.Bucheon-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Open BionicsBristol Bristol, City of, United KingdomManufacturer0000api.fda.gov
Ossur AmericasWest Deptford, NJ, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Oymotion Technologies Co., Ltd.shanghai, ChinaManufacturer0000api.fda.gov
Ossur Iceland ehf.Reykjavik, IcelandComplaint file establishment, Specification developer0000api.fda.gov
Ossur Polska Sp. z o.oDoluje Zachodniopomorskie, PolandContract manufacturer0000api.fda.gov
Otto Bock Healthcare Products GmbHVienna Wien, AustriaManufacturer0000api.fda.gov
PsyonicSan Diego, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
TASKA ProstheticsChristchurch Canterbury, New ZealandManufacturer0000api.fda.gov
Teh Lin Prosthetic & Orthopaedic, Inc.Taipei, TaiwanManufacturer0000api.fda.gov
Touch Bionics LtdLivingston West Lothian, United KingdomManufacturer0000api.fda.gov
Vincent Systems GMBHKarlsruhe Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Yangzhou Sensport Healthcare Supplies Co., Ltd.Yangzhou Jiangsu, ChinaManufacturer0000api.fda.gov

Updated November 2, 2026. 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.