Data / Medical devices / United States / Mobius Bionics LLC
Mobius Bionics LLC: FDA-registered device maker in Manchester, NH, United States, 1 510(k) clearance
Mobius Bionics LLC is registered with the FDA (registration 3012481940) in Manchester, NH, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 9, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012481940
- Address
- 286 Commercial ST, Manchester, NH, United States, 03101
- Owner or operator
- Mobius Bionics LLC (10051633)
- Roles
- Manufacturer
- First device listed
- April 14, 2016
- Registered through
- 2026
- Brand names listed
- DEKA Arm System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography | PAE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 9, 2014 | DEN120016 | DEKA ARM SYSTEM | PAE | Unknown | Deka Integrated Solutions Corporation | accessdata.fda.gov |
Compare with other makers
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.