Data / Medical devices / Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography
Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography (PAE): 3 FDA-registered makers in 1 country
3 establishments in 1 country are registered with the FDA to make Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography (product code PAE, Class 2, 21 CFR 890.3450). 2 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 May 9, 2014, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PAE
- Device class
- 2
- Regulation
- 890.3450
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
Makers of Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography
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 |
|---|---|---|---|---|---|---|---|---|
| Deka Research & Development Corp. | Manchester, NH, United States | Specification developer | 1 | May 9, 2014 | 0 | 0 | 0 | api.fda.gov |
| Mobius Bionics LLC | Manchester, NH, United States | Manufacturer | 1 | May 9, 2014 | 0 | 0 | 0 | api.fda.gov |
| Merrimack Manufacturing | Manchester, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 9, 2014. 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.