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
| Country | Makers |
|---|---|
| United States | 9 |
| China | 6 |
| United Kingdom | 4 |
| Poland | 2 |
| Italy | 1 |
| Sweden | 1 |
| Ukraine | 1 |
| Canada | 1 |
| South Korea | 1 |
| Iceland | 1 |
| Austria | 1 |
| New Zealand | 1 |
| Taiwan | 1 |
| Germany | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Aether Biomedical SP. Z O.O. | Poznan Wielkopolskie, Poland | Complaint file establishment, Manufacturer | 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 | |
| Alt-Bionics, Inc. | San Antonio, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bionit Labs S.R.L. | Soleto Lecce, Italy | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioservo AB | Kista Stockholm, Sweden | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covvi Usa, Inc | San Antonio, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coapt LLC | Chicago, IL, United States | Complaint file establishment, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covvi Ltd. | Leeds West Berkshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Esper LLC. | Kyiv Kyyiv, Misto, Ukraine | 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 Hongfeng Co.,ltd | Foshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hugh Steeper Ltd | Leeds, England, United Kingdom | Complaint file establishment, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hugh Steeper Ltd DBA SteeperUSA | Hopkinton, MA, United States | Complaint file establishment, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Infinite Biomedical Technologies, LLC | Baltimore, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kinova | Boisbriand Quebec, Canada | Manufacturer | 0 | 0 | 1 | 1 | api.fda.gov | |
| Medex Medical Supplies Ltd. | China Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Motion Control, Inc. | Salt Lake City, UT, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Myomo, Inc. | Burlington, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mand.ro Co., Ltd. | Bucheon-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Open Bionics | Bristol Bristol, City of, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ossur Americas | West Deptford, NJ, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oymotion Technologies Co., Ltd. | shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ossur Iceland ehf. | Reykjavik, Iceland | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ossur Polska Sp. z o.o | Doluje Zachodniopomorskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Otto Bock Healthcare Products GmbH | Vienna Wien, Austria | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Psyonic | San Diego, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TASKA Prosthetics | Christchurch Canterbury, New Zealand | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teh Lin Prosthetic & Orthopaedic, Inc. | Taipei, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Touch Bionics Ltd | Livingston West Lothian, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vincent Systems GMBH | Karlsruhe Baden-Wurttemberg, Germany | 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 |
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.