Biotone International, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Biotone International, Inc. makes
Biotone International, Inc. manufactures electrotherapy devices, including the ELITE and STIMRITE models for muscle stimulation, as well as passive heat pads for therapeutic warming. The BIO-TONE MODEL 4 is a specialized electrotherapy unit designed for targeted muscle stimulation and pain management applications.
The company’s portfolio consists of Class II medical devices, all of which are listed via the FDA’s 510(k) pathway. These devices are registered under U.S. regulatory requirements and are based in the United States.
Catalogue
Elite Ref K812538
Regimes: 510(k) Registry: 510(k)Passive Heat Pads Ref K821692
Regimes: 510(k) Registry: 510(k)Bio-Tone Model 4 Ref K811737
Regimes: 510(k) Registry: 510(k)Stimrite Ref K821691
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biotone International, Inc. have in the registry?
The registry currently lists 4 devices for Biotone International, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biotone International, Inc.'s devices?
Among its 4 most recently registered devices, Biotone International, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Biotone International, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Biotone International, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biotone International, Inc. in the registry?
The most recently registered devices listed for Biotone International, Inc. include ELITE, PASSIVE HEAT PADS, BIO-TONE MODEL 4 and STIMRITE.