Wellness - Kegel Training Kit - Purple
Wellness - Kegel Training Kit - Purple (BL-444004) is a Class II device made by Blush Novelties, listed in FDA GUDID since 28 Jan 2025 (UDI-DI 00819835024125), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00819835024125 | Date28 Jan 2025 | StatusListed |
Official records
- AccessGUDID record 00819835024125
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Wellness
- Generic name
- Perineometer
- Model / Ref / Catalog
- Wellness - Kegel Training Kit - Purple, BL-444004
- Primary DI / UDI-DI
- 00819835024125
- 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).
- PERITONE by Laurie Ann Kaiser, Ph.D.
- INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE by Hollister, Inc.
- VAGINAL CHAMBER PELLETHANE-MEDICAL GRADE 2363 by Peritone Research, Ltd.
- PERIPUMP by Deschutes Medical Products, Inc.
- Pelvital System by Pelvital USA, Inc.
- PERIFORM PERINEOMETRIC PROBE, MODEL 8300 by Neen Design, Ltd.
- PERRYMETER(TM) by Perrymeter Systems
- INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE by Empi
- PELVEX HOMETRAINER by Purdue Technology Park
- PP-100, PERSONAL PERINEOMETER by Farrall Instruments, Inc.