K190118 is an FDA 510(k) clearance for the Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III). This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Guangzhou Xinbo Electronic Co., Ltd. (Panyu, CN). The FDA issued a Cleared decision on May 13, 2020, 475 days after receiving the submission on January 24, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K190118 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 2019 |
| Decision Date | May 13, 2020 |
| Days to Decision | 475 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 |