Peritron PRN09300
by Laborie Medical Technologies Canada ULC
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Overview
A comprehensive medical device directory entry for the Peritron, a reliable and accurate Perineometer (Urinary Incontinence Device) designed to diagnose and treat urinary incontinence and sexual dysfunction through voluntary muscle contractions.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10627825006276 | Date21 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK983052 | Date19 Oct 1998 | StatusActive |
Official records
- AccessGUDID record 10627825006276
- FDA 510(k) database K983052
Across registries
- FDA 510(k) K983052 decided 19 Oct 1998 Active
- FDA GUDID UDI-DI 10627825006276 listed 21 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K983052
- Listed FDA GUDID 10627825006276
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Peritron
- Generic name
- Perineometer
- Model / reference
- PRN09300
- Primary DI / UDI-DI
- 10627825006276
- 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).
- ELITE BIOFEEDBACK by Laborie Medical Technologies Corp.
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- 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.
- CONTIMED II BIOFEEDBACK DEV TREAT OF URIN INCONTI by Hollister, Inc.
- PeriCoach by Analytica, Ltd.
- EXTT-101 by Apimeds, Inc.
- EISMAN-TRIES MEP (MULTIPLE ELECTRODE PROBE) by Sandhill Scientific, Inc.
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