The following data is part of a premarket notification filed by Guangzhou Xinbo Electronic Co., Ltd. with the FDA for Dr-ho's Back Pain Relief System Pro (models Bprs-i And Bprs-ii).
| Device ID | K202671 |
| 510k Number | K202671 |
| Device Name: | DR-HO's Back Pain Relief System Pro (Models BPRS-I And BPRS-II) |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| 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 510000 |
| Product Code | NUH |
| Subsequent Product Code | IRT |
| Subsequent Product Code | NGX |
| Subsequent Product Code | NYN |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-14 |
| Decision Date | 2021-11-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970742220223 | K202671 | 000 |