The following data is part of a premarket notification filed by Guangzhou Xinbo Electronic Co., Ltd. with the FDA for Dr-ho's Foot Pad Electrode (models: Dhfre-i, Cp-i, Cp-ii, Cp-iii).
| Device ID | K190118 |
| 510k Number | K190118 |
| Device Name: | Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III) |
| Classification | Electrode, Cutaneous |
| Applicant | Guangzhou Xinbo Electronic Co., Ltd. 23 Building, Phase-II Huachuang Industry Park Panyu, CN 511400 |
| Contact | Sammy Li |
| Correspondent | Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road Huangpu District Guangzhou, CN 511400 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-24 |
| Decision Date | 2020-05-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970742221664 | K190118 | 000 |
| 06970742220001 | K190118 | 000 |