K240805
- 510(k) number
- K240805
- Device name
- Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)
- Applicant
- Pelvital USA, Inc. MN · US
- Product code
- HIR — Perineometer
- Decision date
- 2024-08-01
- Date received
- 2024-03-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K240805.pdf
Official FDA record: K240805
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.