K233784
- 510(k) number
- K233784
- Device name
- ENSO (Model 2)
- Applicant
- Hinge Health, Inc. CA · US
- Product code
- NUH — Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Decision date
- 2024-02-23
- Date received
- 2023-11-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K233784.pdf
Official FDA record: K233784
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.