Levina RS-38
Levina RS-38 is a Class II device made by ZMI Electronics Ltd., cleared under FDA 510(k) K220997 on 1 Sep 2022 and listed in FDA GUDID since 19 Feb 2024 (UDI-DI 04719872332107), 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 | Number04719872332107 | Date19 Feb 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK220997 | Date1 Sep 2022 | StatusActive |
Official records
- AccessGUDID record 04719872332107
- FDA 510(k) database K220997
Across registries
- FDA 510(k) K220997 decided 1 Sep 2022 Active
- FDA GUDID UDI-DI 04719872332107 listed 19 Feb 2024 Listed
Timeline
- Cleared FDA 510(k) K220997
- Listed FDA GUDID 04719872332107
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Levina
- Generic name
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Model / Ref / Catalog
- RS-38
- Primary DI / UDI-DI
- 04719872332107
- 510(k) Number
- FDA product code
- NGX, NUH, NYN
- GMDN term
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Device class
- Class II
- Regulation number
- 890.5850, 882.5890
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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