Flowell Fw-IPC4M
by Xiamen Weiyou Intelligent Technology Co., Ltd 4 variants
Flowell Fw-IPC4M is a freestanding electric massager (FDA Class II; FDA product code IRP, Massager, Powered Inflatable Tube) made by Xiamen Weiyou Intelligent Technology Co., Ltd, cleared under FDA 510(k) K233238 on 14 Jun 2024 and listed in FDA GUDID since 4 Nov 2024 (UDI-DI 06971234470218), 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 | Number06971234470218 | Date4 Nov 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK233238 | Date14 Jun 2024 | StatusActive |
Official records
- AccessGUDID record 06971234470218
- FDA 510(k) database K233238
Across registries
- FDA 510(k) K233238 decided 14 Jun 2024 Active
- FDA GUDID UDI-DI 06971234470218 listed 4 Nov 2024 Listed
Timeline
- Cleared FDA 510(k) K233238
- Listed FDA GUDID 06971234470218
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Flowell
- Generic name
- Freestanding electric massager
- Model / reference
- FW-IPC4M
- Primary DI / UDI-DI
- 06971234470218
- 510(k) Number
- FDA product code
- IRP
- GMDN term
- Freestanding electric massager
- Device class
- Class II
- Regulation number
- 890.5650
- GUDID distribution status
- In Commercial Distribution
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