Apex Metal, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Apex Metal, Inc. makes
Apex Metal, Inc. manufactures low air loss therapy systems and beds designed to reduce pressure injuries for patients at risk of pressure ulcers. These include portable units like the CARE TEC Portable Low Air Loss Therapy System and stationary beds such as the AIRTEC2 and HYDROTEC Low Air Loss Therapy Beds, which use alternating air pressure to distribute weight and improve patient comfort.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. These devices are intended for use in clinical settings and are subject to compliance with U.S. regulatory standards. The manufacturer is based in the United States.
Catalogue
Care Tec Portable Low Air Loss Therapy System Ref K970362
Regimes: 510(k) Registry: 510(k)AIRTEC2 Low Air Loss Therapy Bed Ref K970364
Regimes: 510(k) Registry: 510(k)Hydrotec Low Air Loss Therapy Bed Ref K970363
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Apex Metal, Inc. have in the registry?
The registry currently lists 3 devices for Apex Metal, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Apex Metal, Inc.'s devices?
Among its 3 most recently registered devices, Apex Metal, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Apex Metal, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Apex Metal, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Apex Metal, Inc. in the registry?
The most recently registered devices listed for Apex Metal, Inc. include CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM, AIRTEC2 LOW AIR LOSS THERAPY BED and HYDROTEC LOW AIR LOSS THERAPY BED.