Data / Medical devices / Switzerland / Strongback Mobility AG
Strongback Mobility AG: FDA-registered device maker in Pfaeffikon Schwyz, Switzerland, 1 510(k) clearance
Strongback Mobility AG is registered with the FDA (registration 3042166406) in Pfaeffikon Schwyz, Switzerland. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 22, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042166406
- Address
- c/o blueAUDIT GmbH, Schindellegistrasse 73, Pfaeffikon Schwyz, Switzerland, 8808
- Owner or operator
- Strongback Mobility AG (10094339)
- Roles
- Specification developer
- First device listed
- December 4, 2025
- Registered through
- 2026
- Brand names listed
- Strongback SEATA
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Walker, Mechanical | ITJ | 1 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| September 22, 2026 | K253762 | ErgoSteel (ES0001/696) | IOR | Substantially Equivalent | Strongback Mobility AG C/O Blueaudit GmbH | accessdata.fda.gov |
Compare with other makers
Updated September 22, 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.