Universal Electrodes
by Neurometrix, Inc. 2 variants
510(k) K081871
Universal Electrodes is a medical device (FDA Class II; FDA product code GXY, Electrode, Cutaneous) made by Neurometrix, Inc., cleared under FDA 510(k) K081871 on 29 Sep 2008, 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 | NumberK081871 | Date29 Sep 2008 | StatusActive |
Official records
- FDA 510(k) database K081871
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GXY
- Device class
- Class II
- Regulation
- 21 CFR Part 882.1320
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
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