K233362
- 510(k) number
- K233362
- Device name
- Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)
- Applicant
- Pelvital USA, Inc. MN · US
- Product code
- HIR — Perineometer
- Decision date
- 2023-12-29
- Date received
- 2023-10-02
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K233362.pdf
Official FDA record: K233362
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.