General Components Intl., Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What General Components Intl., Inc. makes
General Components Intl., Inc. manufactures zero-gravity wheelchairs, including customizable components and modifications designed to reduce pressure points and improve user comfort. These devices are intended for long-term seating in clinical and homecare settings, with adjustments for weight distribution and posture support.
The company’s products are classified as Class I medical devices under FDA regulations, with relevant models authorised via the 510(k) pathway. The portfolio is listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Zero Gravity Wheelchair Ref K931751
Regimes: 510(k) Registry: 510(k)Zero Gravity Wheelchair Components, Modification Ref K933051
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does General Components Intl., Inc. have in the registry?
The registry currently lists 2 devices for General Components Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list General Components Intl., Inc.'s devices?
Among its 2 most recently registered devices, General Components Intl., Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do General Components Intl., Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for General Components Intl., Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from General Components Intl., Inc. in the registry?
The most recently registered devices listed for General Components Intl., Inc. include ZERO GRAVITY WHEELCHAIR and ZERO GRAVITY WHEELCHAIR COMPONENTS, MODIFICATION.