MaxiPEP 032-10-301U
MaxiPEP 032-10-301U is an incentive spirometer (FDA Class II; FDA product code BWF, Spirometer, Therapeutic (Incentive)) made by Enchant Tek. Co, Ltd., cleared under FDA 510(k) K233855 on 2 Feb 2024 and listed in FDA GUDID since 28 May 2026 (UDI-DI 04719882305610), 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 | Number04719882305610 | Date28 May 2026 | StatusListed |
| United States | FDA 510(k) | NumberK233855 | Date2 Feb 2024 | StatusActive |
Official records
- AccessGUDID record 04719882305610
- FDA 510(k) database K233855
Across registries
- FDA 510(k) K233855 decided 2 Feb 2024 Active
- FDA GUDID UDI-DI 04719882305610 listed 28 May 2026 Listed
Timeline
- Cleared FDA 510(k) K233855
- Listed FDA GUDID 04719882305610
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MaxiPEP
- Generic name
- Incentive spirometer
- Model / Ref / Catalog
- 032-10-301U
- Primary DI / UDI-DI
- 04719882305610
- 510(k) Number
- FDA product code
- BWF
- GMDN term
- Incentive spirometer
- Device class
- Class II
- Regulation number
- 868.5690
- GUDID distribution status
- In Commercial Distribution
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