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 |