ENSO (Model 2)— 510(k) K233784
Substantially EquivalentHinge Health, Inc.
FDA 510(k) clearance K233784 for ENSO (Model 2), Substantially Equivalent on 2024-02-23. Applicant: Hinge Health, Inc.. Device class: 2.
Clearance details
- Applicant
- Hinge Health, Inc.
- Product code
- Code NUH
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Francisco, CA, US
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