The following data is part of a premarket notification filed by Gymmax Technology Shenzen Co., Ltd. with the FDA for Electrical Stimulator System.
Device ID | K192201 |
510k Number | K192201 |
Device Name: | Electrical Stimulator System |
Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
Applicant | Gymmax Technology Shenzen Co., Ltd. East 5F, A2 Building, Huimingsheng DingFeng Technology Park, Fuhai Street, Fuyong Town, Baoan District Shenzhen City, CN 518103 |
Contact | Benson Wang |
Correspondent | Salon Chen IMD Medical & Drug Technology Service Institutions Tianbao Office Room 225, Sha Tai Road No.209 Shenzhen City, CN 518117 |
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 | 2019-08-13 |
Decision Date | 2020-06-12 |