Well Brain International, Ltd.
Country not established
- Devices
- 7
What Well Brain International, Ltd. makes
Well Brain International, Ltd. manufactures resistance training equipment designed for home and gym use, including adjustable weight systems like the Gymform Total ABS and dual-flex belts. Their products include core and abdominal-focused devices such as the Gymform ABS & Core and ABS-A-Round, which incorporate modular resistance components for targeted muscle engagement.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company’s portfolio is listed in the FDA’s 510(k) registry, reflecting compliance with U.S. medical device authorisation requirements. Well Brain International, Ltd. is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Gymform Total ABS Ref K202653
Regimes: 510(k) Registry: 510(k)Gymform Dual Flex Belt Model Wb-162 Ref K111781
Regimes: 510(k) Registry: 510(k)Gymform Abs & Core Ref K142055
Regimes: 510(k) Registry: 510(k)Gymform Abs-A-Round Ref K130074
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Well Brain International, Ltd. have in the registry?
The registry currently lists 7 devices for Well Brain International, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Well Brain International, Ltd.'s devices?
Among its 7 most recently registered devices, Well Brain International, Ltd. has devices listed in FDA 510(k) (4 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Well Brain International, Ltd.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Well Brain International, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Well Brain International, Ltd. in the registry?
The most recently registered devices listed for Well Brain International, Ltd. include Gymform Abs-A-Round VDP0016, Gymform Total ABS VDPGYCIND0132, Gymform Total ABS Platinum VDPGYCIND0131 and Gymform Total ABS.