800-Air-Wats, Inc.
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- Devices
- 1
What 800-Air-Wats, Inc. makes
800-Air-Wats, Inc. manufactures portable tracheostomy humidification units designed to deliver moisture to patients requiring tracheostomy care. These devices are intended for use in both clinical and home settings to maintain airway hydration and reduce complications associated with dry secretions.
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. The devices are listed in the FDA’s 510(k) registry, adhering to US regulatory requirements for their intended use.
Catalogue
Portable Tracheostomy Humidification Unit Ref K874082
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does 800-Air-Wats, Inc. have in the registry?
The registry currently lists 1 device for 800-Air-Wats, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list 800-Air-Wats, Inc.'s devices?
Among its 1 most recently registered device, 800-Air-Wats, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do 800-Air-Wats, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for 800-Air-Wats, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from 800-Air-Wats, Inc. in the registry?
The most recently registered devices listed for 800-Air-Wats, Inc. include PORTABLE TRACHEOSTOMY HUMIDIFICATION UNIT.