The following data is part of a premarket notification filed by Well Brain International Ltd. with the FDA for Gymform Total Abs.
| Device ID | K202653 |
| 510k Number | K202653 |
| Device Name: | Gymform Total ABS |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | Well Brain International Ltd. Room 1403 Fook Yip Building, 53-57 Kwai Fung Crescent, Kwai Chung Hong Kong, CN |
| Contact | Victor K. Wai |
| Correspondent | Jet Li Guangzhou Kinda Biological Technology Co., Ltd 6F, No.1 TianTai Road, Science City, LuoGang District, Guangzhou, CN |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-14 |
| Decision Date | 2021-01-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973698290081 | K202653 | 000 |
| 06973698290074 | K202653 | 000 |