Newwave Medical, LLC
United StatesFDA applicant, unverified
- Devices
- 3
What Newwave Medical, LLC makes
Newwave Medical, LLC manufactures electrotherapy devices, including disposable ULTRA-GARMENT ELECTRODES for muscle stimulation and two models of interferential therapy units: the SMARTWAVE IF 2000 and SMARTWAVE MS 2000.
These products are classified as Class II devices under FDA regulations and are listed via 510(k) clearance. The company operates from the United States.
Catalogue
Ultra-Garment Electrode Ref K993130
Regimes: 510(k) Registry: 510(k)Smartwave If 2000 Ref K003631
Regimes: 510(k) Registry: 510(k)Smartwave Ms 2000 Ref K041063
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Newwave Medical, LLC have in the registry?
The registry currently lists 3 devices for Newwave Medical, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Newwave Medical, LLC's devices?
Among its 3 most recently registered devices, Newwave Medical, LLC has devices listed in FDA 510(k) (3 devices).
What risk classes do Newwave Medical, LLC's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Newwave Medical, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Newwave Medical, LLC in the registry?
The most recently registered devices listed for Newwave Medical, LLC include ULTRA-GARMENT ELECTRODE, SMARTWAVE IF 2000 and SMARTWAVE MS 2000.