Data / Medical devices / United States / Evolution Devices, Inc.
Evolution Devices, Inc.: FDA-registered device maker in San Francisco, CA, United States, 1 510(k) clearance
Evolution Devices, Inc. is registered with the FDA (registration 3030418885) in San Francisco, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 28, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030418885
- Address
- 1231 Stevenson Street STE 201, San Francisco, CA, United States, 94103
- Owner or operator
- Evolution Devices, Inc. (10092283)
- Roles
- Specification developer
- First device listed
- December 19, 2024
- Registered through
- 2026
- Brand names listed
- EvoWalk 1 System, Evowalk
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Neuromuscular, External Functional | GZI | 2 | 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 |
|---|---|---|---|---|---|---|
| December 28, 2023 | K230997 | EvoWalk 1.0 System | GZI | Substantially Equivalent | Evolution Devices, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 28, 2023. 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.