The following data is part of a premarket notification filed by Well Brain International, Ltd. with the FDA for Gymform Dual Flex Belt Model Wb-162.
| Device ID | K111781 |
| 510k Number | K111781 |
| Device Name: | GYMFORM DUAL FLEX BELT MODEL WB-162 |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | WELL BRAIN INTERNATIONAL, LTD. 100 GRANVILLE ROAD TSIM SHA TSUI EAST, KOWLOON Hong Kong, Sar China, CN Ch |
| Contact | Victor K Wai |
| Correspondent | Victor K Wai WELL BRAIN INTERNATIONAL, LTD. 100 GRANVILLE ROAD TSIM SHA TSUI EAST, KOWLOON Hong Kong, Sar China, CN Ch |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-24 |
| Decision Date | 2012-07-11 |
| Summary: | summary |