GTG Wellness Co., Ltd.
South KoreaFDA applicant, unverified
- Devices
- 19
What GTG Wellness Co., Ltd. makes
GTG Wellness Co., Ltd. manufactures the Opera Lebody (Gold) and Opera Lebody (Zafiro), which appear to be wearable devices designed for body composition analysis and health monitoring, likely using bioelectrical impedance technology.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Search and filter all 19 devicesCompany details
- DUNS number
- 689458057
Frequently asked questions
How many devices does GTG Wellness Co., Ltd. have in the registry?
The registry currently lists 19 devices for GTG Wellness Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list GTG Wellness Co., Ltd.'s devices?
Among its 19 most recently registered devices, GTG Wellness Co., Ltd. has devices listed in FDA 510(k) (1 device) and FDA GUDID (18 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do GTG Wellness Co., Ltd.'s devices fall under?
Among its 19 most recently registered devices, the classes recorded for GTG Wellness Co., Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from GTG Wellness Co., Ltd. in the registry?
The most recently registered devices listed for GTG Wellness Co., Ltd. include OMZ-100 FACE MASK, OLG-200 FULLSET, LEF-100 FullSet and BBL-100 FULLSET.