lecuag HK701
by Guangzhou Hua Kai Electronic Technology Co., Ltd.
lecuag HK701 is a Class II device made by Guangzhou Hua Kai Electronic Technology Co., Ltd., cleared under FDA 510(k) K221251 on 29 Jul 2022 and listed in FDA GUDID since 17 Jan 2023 (UDI-DI 06974241370458), 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 | Number06974241370458 | Date17 Jan 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK221251 | Date29 Jul 2022 | StatusActive |
Official records
- AccessGUDID record 06974241370458
- FDA 510(k) database K221251
Across registries
- FDA 510(k) K221251 decided 29 Jul 2022 Active
- FDA GUDID UDI-DI 06974241370458 listed 17 Jan 2023 Listed
Timeline
- Cleared FDA 510(k) K221251
- Listed FDA GUDID 06974241370458
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- lecuag
- Generic name
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Model / reference
- HK701
- Primary DI / UDI-DI
- 06974241370458
- 510(k) Number
- FDA product code
- NUH, IRT, NGX
- GMDN term
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Device class
- Class II
- Regulation number
- 882.5890, 890.5740, 890.5850
- GUDID distribution status
- In Commercial Distribution
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