Prothia USA, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Prothia USA, Inc. makes
Prothia USA, Inc. manufactures nerve stimulators, including the ELPHA 500 and MYOTEST NERVE STIMULATOR, as well as electromyography devices like the MYOGRAPH 2000. The company also produces the AMPLIGREFFE, a device for nerve signal amplification, and a universal instrumentation set for neurovascular procedures.
These devices are regulated under FDA 510(k) clearance, with classifications spanning Class I and Class II. The company’s products are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Elpha 500 Ref K823581
Regimes: 510(k) Registry: 510(k)Myotest Nerve Stimulator Ref K823583
Regimes: 510(k) Registry: 510(k)Ampligreffe Ref K830993
Regimes: 510(k) Registry: 510(k)Universal Instru. Set For Neurovascular Ref K831071
Regimes: 510(k) Registry: 510(k)Myograph 2000 Ref K830058
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Prothia USA, Inc. have in the registry?
The registry currently lists 5 devices for Prothia USA, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Prothia USA, Inc.'s devices?
Among its 5 most recently registered devices, Prothia USA, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Prothia USA, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Prothia USA, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Prothia USA, Inc. in the registry?
The most recently registered devices listed for Prothia USA, Inc. include ELPHA 500, MYOTEST NERVE STIMULATOR, AMPLIGREFFE and UNIVERSAL INSTRU. SET FOR NEUROVASCULAR.