The following data is part of a premarket notification filed by Guangzhou Xinbo Electronic Co., Ltd. with the FDA for Dr-ho's Electro Therapy Conductive Gel.
| Device ID | K200402 |
| 510k Number | K200402 |
| Device Name: | DR-HO'S Electro Therapy Conductive Gel |
| Classification | Media, Electroconductive |
| Applicant | Guangzhou Xinbo Electronic Co., Ltd. 23 Building, Phase-II, Huachuang Industry Park, Panyu, Guangzhou,China. Guangzhou, CN 511450 |
| Contact | Sammy Li |
| Correspondent | Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, CN 510700 |
| Product Code | GYB |
| CFR Regulation Number | 882.1275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-19 |
| Decision Date | 2020-11-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970742221671 | K200402 | 000 |