Sanuwave, Inc.
United Statesfrom the FDA registration address FDA FEI 3006261799
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
dermaPACE System Ref DEN160037
Regimes: De Novo Registry: De NovoHealthtronics Ossatron Ref P990086
Regimes: PMA, withdrawn Registry: PMA
Company details
- FDA FEI number
- 3006261799
- Address
- 9600 W 76th St, Eden Prairie, MN, 55344
Frequently asked questions
How many devices does Sanuwave, Inc. have in the registry?
The registry currently lists 2 devices for Sanuwave, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sanuwave, Inc.'s devices?
Among its 2 most recently registered devices, Sanuwave, Inc. has devices listed in FDA 510(k) (1 device) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Sanuwave, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Sanuwave, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Sanuwave, Inc. in the registry?
The most recently registered devices listed for Sanuwave, Inc. include dermaPACE System and HEALTHTRONICS OSSATRON.