Unique Flotation Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Unique Flotation Systems, Inc. makes
Unique Flotation Systems, Inc. manufactures air-fluidized bed systems designed for patient flotation and mobility support, including Stage IV and Stage III models. These devices are intended for clinical use in assisting patients with limited mobility or pressure injury risk management.
The company’s portfolio is regulated under Class II medical devices in the United States, with products authorised through the FDA’s 510(k) clearance process. These devices are listed in the FDA’s 510(k) database, adhering to U.S. regulatory requirements for air-fluidized therapy systems.
Catalogue
Stage Iv, Air-Fluidize Bed Ref K904008
Regimes: 510(k) Registry: 510(k)Stage Iii Ref K903659
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Unique Flotation Systems, Inc. have in the registry?
The registry currently lists 2 devices for Unique Flotation Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Unique Flotation Systems, Inc.'s devices?
Among its 2 most recently registered devices, Unique Flotation Systems, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Unique Flotation Systems, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Unique Flotation Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Unique Flotation Systems, Inc. in the registry?
The most recently registered devices listed for Unique Flotation Systems, Inc. include STAGE IV, AIR-FLUIDIZE BED and STAGE III.