Attain 3200000A1
Attain 3200000A1 is a Class II device made by Incontrol Medical, LLC, cleared under FDA 510(k) K182022 on 15 Mar 2019 and listed in FDA GUDID since 19 Mar 2019 (UDI-DI 00851508007103), 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 | Number00851508007103 | Date19 Mar 2019 | StatusListed |
| United States | FDA 510(k)SESK | NumberK182022 | Date15 Mar 2019 | StatusActive |
Official records
- AccessGUDID record 00851508007103
- FDA 510(k) database K182022
Across registries
- FDA 510(k) K182022 decided 15 Mar 2019 Active
- FDA GUDID UDI-DI 00851508007103 listed 19 Mar 2019 Listed
Timeline
- Cleared FDA 510(k) K182022
- Listed FDA GUDID 00851508007103
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Attain
- Generic name
- Pelvic floor muscle exerciser
- Model / Ref / Catalog
- 3200000A1
- Primary DI / UDI-DI
- 00851508007103
- 510(k) Number
- FDA product code
- KPI
- GMDN term
- Pelvic floor muscle exerciser
- Device class
- Class II
- Regulation number
- 876.5320
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Size
- Length — 4.1 Inch
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