Reia FP01-K
by Reia, LLC
Reia FP01-K is a pelvic-organ-supporting pessary (FDA Class II; FDA product code HHW, Pessary, Vaginal) made by Reia, LLC, cleared under FDA 510(k) K232677 on 21 May 2024 and listed in FDA GUDID since 5 Sep 2024 (UDI-DI 00860012119394), 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 | Number00860012119394 | Date5 Sep 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK232677 | Date21 May 2024 | StatusActive |
Official records
- AccessGUDID record 00860012119394
- FDA 510(k) database K232677
Across registries
- FDA 510(k) K232677 decided 21 May 2024 Active
- FDA GUDID UDI-DI 00860012119394 listed 5 Sep 2024 Listed
Timeline
- Cleared FDA 510(k) K232677
- Listed FDA GUDID 00860012119394
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Reia
- Generic name
- Pelvic-organ-supporting pessary
- Model / reference
- FP01-K
- Primary DI / UDI-DI
- 00860012119394
- 510(k) Number
- FDA product code
- HHW
- GMDN term
- Pelvic-organ-supporting pessary
- Device class
- Class II
- Regulation number
- 884.3575
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code HHW (Pessary, Vaginal).
- TIPI OTC by Contipi, Ltd.
- Marina Medical Silicone Pessary by MARINA MEDICAL INSTRUMENTS, INC.
- PELVX INCONTINENCE DISH, MODEL 301-306 by Deschutes Medical Products, Inc.
- Mentor Evacare Vaginal Pessaries by Mentor Corp.
- BLADDER NECK SUPPORT PROTHESIS FITTING KIT by Johnson & Johnson Medical, Inc.
- INFLAT-O-BALL by Milex Products, Inc.
- Always/Tampax bladder supports by PROCTER & GAMBLE CO.
- Panpac Disposable Pessary Fitting Set by PANPAC MEDICAL CORPORATION
- PESSARY FLEXIBLE SILICONE DONUT RING by BIOTEQUE AMERICA, INC.
- TIPI by Contipi, Ltd.