Rectal Sensor Unit TTL SA6051
Rectal Sensor Unit TTL SA6051 is a Class II device made by Thought Technology Ltd., cleared under FDA 510(k) K932149 on 11 May 1995 and listed in FDA GUDID since 31 Aug 2017 (UDI-DI 07540191000432), active as of 23 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 | Number07540191000432 | Date31 Aug 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK932149 | Date11 May 1995 | StatusActive |
Official records
- AccessGUDID record 07540191000432
- FDA 510(k) database K932149
Across registries
- FDA 510(k) K932149 decided 11 May 1995 Active
- FDA GUDID UDI-DI 07540191000432 listed 31 Aug 2017 Listed
Timeline
- Cleared FDA 510(k) K932149
- Listed FDA GUDID 07540191000432
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Rectal Sensor Unit TTL
- Generic name
- Pelvic floor muscle exerciser
- Model / reference
- SA6051
- Primary DI / UDI-DI
- 07540191000432
- 510(k) Number
- FDA product code
- HIR
- GMDN term
- Pelvic floor muscle exerciser
- 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).
- VAGATEX by Vagatex
- 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