K253478
- 510(k) number
- K253478
- Device name
- Motive Muscle Stimulator for Lower Back (OT01-1003)
- Applicant
- Motive Health, Inc. AZ · US
- Product code
- NGX — Stimulator, Muscle, Powered, For Muscle Conditioning
- Decision date
- 2025-11-06
- Date received
- 2025-10-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K253478.pdf
Official FDA record: K253478
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.