Data / Medical devices / United States / Hinge Health Inc.
Hinge Health Inc.: FDA-registered device maker in San Francisco, CA, United States, 3 510(k) clearances
Hinge Health Inc. is registered with the FDA (registration 3016856381) in San Francisco, CA, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 16, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3016856381
- FEI number
- 3012640203
- Address
- 455 Market Street Suite 700, San Francisco, CA, United States, 94105
- Owner or operator
- Hinge Health Inc. (10082971)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- October 18, 2021
- Registered through
- 2026
- Brand names listed
- ENSO, Enso, Enso for Migraine
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | PCC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| April 16, 2026 | K254216 | Enso for Migraine | PCC | Substantially Equivalent | Hinge Health, Inc. | accessdata.fda.gov |
| February 23, 2024 | K233784 | ENSO (Model 2) | NUH | Substantially Equivalent | Hinge Health, Inc. | accessdata.fda.gov |
| May 20, 2016 | K160052 | CUR Model 1 | NUH | Substantially Equivalent | Thimble Bioelectronics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
Updated April 16, 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.