Flyte MTI-1
Flyte MTI-1 is a Class II device made by Pelvital USA, Inc., cleared under FDA 510(k) K200409 on 10 Jul 2020 and listed in FDA GUDID since 30 Jun 2023 (UDI-DI 00860331002032), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00860331002032 | Date30 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK200409 | Date10 Jul 2020 | StatusActive |
Official records
- AccessGUDID record 00860331002032
- FDA 510(k) database K200409
Across registries
- FDA 510(k) K200409 decided 10 Jul 2020 Active
- FDA GUDID UDI-DI 00860331002032 listed 30 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K200409
- Listed FDA GUDID 00860331002032
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Flyte
- Generic name
- Perineometer
- Model / reference
- MTI-1
- Primary DI / UDI-DI
- 00860331002032
- 510(k) Number
- FDA product code
- HIR
- GMDN term
- Perineometer
- Device class
- Class II
- Regulation number
- 884.1425
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code HIR (Perineometer).
- PeriCoach OTC by Analytica, Ltd.
- MYOTRAC2D/CS by THOUGHT TECHNOLOGY LTD.
- LEva Pelvic Digital Health System by Renovia, Inc.
- ELECTRO-MYOGRAPHIC PERINEOMETER by Verimed Holdings, Inc.
- MILEX KEGEL PERINEAL EXERCISER by Milex Products, Inc.
- leva Pelvic Floor Trainer by Renovia, Inc.
- REFLEX TREATMENT SYSTEM by Deschutes Medical Products, Inc.
- THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE by THOUGHT TECHNOLOGY LTD.
- PELVIC MUSCLE THERAPY by Colonial Medical Supply
- MONSANTO SANTOPRENE (PERITONE DEVICE) by Peritone Research, Ltd.