The following data is part of a premarket notification filed by Guangzhou Xinbo Electronic Co., Ltd. with the FDA for Xinbo Electrode (model: Neck Therapy Pro - I, Neck Therapy Pro - Ii, Neck Therapy Pro - Iii, Neck Therapy Pro - Iv).
| Device ID | K172887 |
| 510k Number | K172887 |
| Device Name: | XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) |
| Classification | Electrode, Cutaneous |
| Applicant | Guangzhou Xinbo Electronic Co., Ltd. 2nd Building, Juntuo Industry Park, XingyeDadao Nancun Town, Panyu District Guangzhou, CN 511400 |
| Contact | Sammy Li |
| Correspondent | Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, CN 510006 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-21 |
| Decision Date | 2018-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970742221657 | K172887 | 000 |
| 06970742221640 | K172887 | 000 |
| 06970742221633 | K172887 | 000 |
| 06970742221626 | K172887 | 000 |
| 06970742220216 | K172887 | 000 |
| 06970742220209 | K172887 | 000 |