The following data is part of a premarket notification filed by Guangzhou Xinbo Electronic Co., Ltd. with the FDA for Pain Therapy Device.
| Device ID | K163611 |
| 510k Number | K163611 |
| Device Name: | Pain Therapy Device |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Guangzhou Xinbo Electronic Co., Ltd. 2nd Building, Juntuo Industry Park, Xingye Dadao Nancun Town, Panyu District Guangzhou, CN 511400 |
| Contact | Sammy Li |
| Correspondent | Cecilia Ceng Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, CN 510000 |
| Product Code | NUH |
| 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 | 2016-12-22 |
| Decision Date | 2017-09-19 |
| Summary: | summary |