TELIGEN System Peripheral Motor Nerve Stimulation Indications
510(k) K223438
TELIGEN System Peripheral Motor Nerve Stimulation Indications is a Class II device made by Medos International SARL, cleared under FDA 510(k) K223438 on 10 Feb 2023, active as of 10 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK223438 | Date10 Feb 2023 | StatusActive |
Official records
- FDA 510(k) database K223438
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PDQ
- Device class
- Class II
- Regulation
- 21 CFR Part 874.1820
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent