510(k) K240805
K240805 is an FDA 510(k) premarket notification submitted by Pelvital USA, Inc. for the device "Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)". The FDA issued a decision of Substantially Equivalent on August 1, 2024. The device falls under product code HIR (Perineometer), a Class II device regulated under 21 CFR 884.1425. Pelvital USA, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 1, 2024
- Date Received
- March 25, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Perineometer
- Device Class
- Class II
- Regulation Number
- 884.1425
- Review Panel
- GU
- Submission Type