K200402 is an FDA 510(k) clearance for the DR-HO'S Electro Therapy Conductive Gel. This device is classified as a Media, Electroconductive (Class II - Special Controls, product code GYB).
Submitted by Guangzhou Xinbo Electronic Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on November 25, 2020, 280 days after receiving the submission on February 19, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1275.
| 510(k) Number | K200402 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 2020 |
| Decision Date | November 25, 2020 |
| Days to Decision | 280 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GYB - Media, Electroconductive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1275 |