Tens-Ems-14
by Emsi
510(k) K083030
Tens-Ems-14 is a medical device (FDA Class II; FDA product code GZJ, Stimulator, Nerve, Transcutaneous, For Pain Relief) made by Emsi, cleared under FDA 510(k) K083030 on 5 Feb 2009, 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 | FDA 510(k)SESE | NumberK083030 | Date5 Feb 2009 | StatusActive |
Official records
- FDA 510(k) database K083030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GZJ
- Device class
- Class II
- Regulation
- 21 CFR Part 882.5890
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
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