K221274
- 510(k) number
- K221274
- Device name
- StarFormer, TightWave
- Applicant
- Fotona D.O.O. SI
- Product code
- IPF — Stimulator, Muscle, Powered
- Decision date
- 2023-09-29
- Date received
- 2022-05-02
- 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: K221274.pdf
Official FDA record: K221274
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.