K230167
- 510(k) number
- K230167
- Device name
- BACK 4
- Applicant
- Swims America Corp NY · US
- Product code
- IPF — Stimulator, Muscle, Powered
- Decision date
- 2023-09-14
- Date received
- 2023-01-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K230167.pdf
Official FDA record: K230167
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.