Urostym PRO180
by Laborie Medical Technologies Canada ULC
Urostym PRO180 is a Class II device made by Laborie Medical Technologies Canada ULC, listed in FDA GUDID since 21 Sep 2016 (UDI-DI 00627825006019), 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 | Number00627825006019 | Date21 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00627825006019
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Urostym
- Generic name
- Biofeedback system
- Model / reference
- PRO180
- Primary DI / UDI-DI
- 00627825006019
- FDA product code
- HIR, KPI
- GMDN term
- Biofeedback system
- Device class
- Class II
- Regulation number
- 884.1425, 876.5320
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code HIR (PERINEOMETER).
- PERITONE DISPOSAL SHEATH - RUBBER AND VINYL by Laurie Ann Kaiser, Ph.D.
- INNER PEACE by Kamabry, Inc., Dba Inner Peace For Women
- PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25 by THE PROMETHEUS GROUP
- Vibrance Pelvic Trainer by Bioinfinity (M) Sdn. Bhd.
- ELITE BIOFEEDBACK by Laborie Medical Technologies Corp.
- Flyte by Pelvital USA, Inc.
- KEGELMASTER 2000 by Kegelmaster 2000, Ltd.
- PERITRON PERINEOMETER MODEL 9300V OR 9300A by Cardio Design Pty., Ltd.
- Leva Pelvic Health System by Renovia, Inc.
- VIBRANCE KEGEL DEVICE (VKD) by Bioinfinity (M) Sdn. Bhd.
Other devices from Laborie Medical Technologies Canada ULC
See all devices from Laborie Medical Technologies Canada ULC →