K864032 is an FDA 510(k) clearance for the EM TENS WINDOW ELECTRODES. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Electromed Intl., Ltd. (Waltham, US). The FDA issued a Cleared decision on December 22, 1986, 68 days after receiving the submission on October 15, 1986.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K864032 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 1986 |
| Decision Date | December 22, 1986 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | GXY — Electrode, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1320 |