Data / Medical devices / Hook, External Limb Component, Mechanical
Hook, External Limb Component, Mechanical (IQX): 7 FDA-registered makers in 4 countries
7 establishments in 4 countries are registered with the FDA to make Hook, External Limb Component, Mechanical (product code IQX, Class 1, 21 CFR 890.3420). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on June 13, 1978, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- IQX
- Device class
- 1
- Regulation
- 890.3420
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Taiwan | 2 |
| United Kingdom | 1 |
| Germany | 1 |
Makers of Hook, External Limb Component, Mechanical
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 |
|---|---|---|---|---|---|---|---|---|
| Fillauer, LLC | Chattanooga, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Invisible Hand Enterprises, LLC | Westminster, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marins Inc. | Georgetown, DE, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Open Bionics | Bristol Bristol, City of, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH | DUDERSTADT Lower Saxony, Germany | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teh Lin Prosthetic & Orthopaedic, Inc. | Taipei, Taiwan | 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 |
Updated June 13, 1978. 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.