K082065 is an FDA 510(k) clearance for the WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Well-Life Healthcare Limited (Bonita Springs, US). The FDA issued a Cleared decision on April 10, 2009, 262 days after receiving the submission on July 22, 2008.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K082065 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 2008 |
| Decision Date | April 10, 2009 |
| Days to Decision | 262 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXY — Electrode, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1320 |