K173186 is an FDA 510(k) clearance for the S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Everyway Medical Instruments Co.,Ltd (New Taipei City, TW). The FDA issued a Cleared decision on February 28, 2018, 149 days after receiving the submission on October 2, 2017.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K173186 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 2017 |
| Decision Date | February 28, 2018 |
| Days to Decision | 149 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | GXY — Electrode, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1320 |