K190617 is an FDA 510(k) clearance for the Wrap accessory electrodes. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Hi-Dow International, Inc. (Maryland Heights, US). The FDA issued a Cleared decision on July 2, 2019, 113 days after receiving the submission on March 11, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K190617 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 2019 |
| Decision Date | July 02, 2019 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | GXY — Electrode, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1320 |