Sonomotion, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Sonomotion, Inc. makes
Sonomotion, Inc. manufactures lithotripters, including the Stone Clear (SC-LP9-01) and Break Wave models, designed for extracorporeal shockwave therapy to fragment urinary stones.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Stone Clear (BWSC-LP9-02) Ref K262200
Regimes: 510(k) Registry: 510(k)Stone Clear (SC-LP9-01) Ref DEN230082
Regimes: De Novo Registry: De NovoBreak Wave Ref K261086
Regimes: 510(k) Registry: 510(k)Break Wave Ref K252913
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sonomotion, Inc. have in the registry?
The registry currently lists 4 devices for Sonomotion, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sonomotion, Inc.'s devices?
Among its 4 most recently registered devices, Sonomotion, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Sonomotion, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Sonomotion, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sonomotion, Inc. in the registry?
The most recently registered devices listed for Sonomotion, Inc. include Stone Clear (BWSC-LP9-02), Stone Clear (SC-LP9-01) and Break Wave.