Data / Medical devices / Assembly, Knee/Shank/Ankle/Foot, External
Assembly, Knee/Shank/Ankle/Foot, External (ISW): 10 FDA-registered makers in 7 countries
10 establishments in 7 countries are registered with the FDA to make Assembly, Knee/Shank/Ankle/Foot, External (product code ISW, Class 2, 21 CFR 890.3500). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on July 8, 1999, and lists 7 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- ISW
- Device class
- 2
- Regulation
- 890.3500
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| India | 1 |
| Japan | 1 |
| Taiwan | 1 |
| Egypt | 1 |
| France | 1 |
| China | 1 |
Makers of Assembly, Knee/Shank/Ankle/Foot, External
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 |
|---|---|---|---|---|---|---|---|---|
| Apothecaries Sundries MFG Pvt Ltd | GURUGRAM Haryana, India | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bionicm | Hongo Bunkyo-ku Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiundar Industrial Co., Ltd. | SHULIN CITY Taipei, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Miracle Medical Industries | El Obour City Al Qahirah, Egypt | Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Otto Bock Healthcare LP | Salt Lake City, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Proteor | Dijon Cedex Cote-d'Or, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Proteor Usa | Tempe, AZ, United States | Complaint file establishment, Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| PROTEOR USA, Gunnison | Gunnison, UT, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rxfunction Inc. | Eden Prairie, MN, United States | 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 July 8, 1999. 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.