9th Wave, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What 9th Wave, Inc. makes
9th Wave, Inc. manufactures low air loss systems (Models 500 & 550) and alternating pressure mattresses (Models 400 & 450) for patient support, as well as alternating pressure pads (Model 200) designed to reduce pressure injuries and improve comfort during prolonged use.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.
Catalogue
9TH Wave Models 500 & 550 Low Air Loss Systems Ref K963620
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
9TH Wave Model 200 Alternating Pressure Pad Ref K963677
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does 9th Wave, Inc. have in the registry?
The registry currently lists 3 devices for 9th Wave, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list 9th Wave, Inc.'s devices?
Among its 3 most recently registered devices, 9th Wave, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do 9th Wave, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for 9th Wave, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from 9th Wave, Inc. in the registry?
The most recently registered devices listed for 9th Wave, Inc. include 9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS, 9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS and 9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD.