The following data is part of a premarket notification filed by Guangzhou Xinbo Electronic Co., Ltd. with the FDA for Pain Therapy Device(model: Dh-p.t.s-i, Dh-p.t.s-ii, Dh-p.t.s-iia, Dh-p.t.s-iib, Dh-cp-i).
| Device ID | K212948 |
| 510k Number | K212948 |
| Device Name: | Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I) |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | Guangzhou Xinbo Electronic Co., Ltd. No.23 Building, The Second Phase, Huachuang Animation Industry Park, Panyu 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 511400 |
| Product Code | NGX |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | IPF |
| Subsequent Product Code | NUH |
| Subsequent Product Code | NYN |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-16 |
| Decision Date | 2021-11-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970742221817 | K212948 | 000 |
| 06970742221800 | K212948 | 000 |
| 06970742221794 | K212948 | 000 |
| 06970742221787 | K212948 | 000 |
| 06970742221770 | K212948 | 000 |