FDA applicant
Hinge Health, Inc.
FDA records 2 decisions for Hinge Health, Inc. (San Francisco, CA) from 2024 to 2026: 2 510(k) clearances. Most are in product codes NUH (Stimulator, Nerve, Transcutaneous…) and PCC (Stimulator, Nerve, Electrical, Transcutaneous…). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Hinge Health, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
Planning a device like Hinge Health, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report