Epineuron Technologies, Inc.
CanadaFDA applicant, unverified FDA FEI 3026023106
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Epineuron Technologies, Inc. makes
Epineuron Technologies, Inc. manufactures the Evala Nerve Stimulator, a device designed for nerve stimulation applications in clinical settings. This product is intended to assist in assessing nerve function and conducting diagnostic evaluations through controlled electrical stimulation.
The Evala Nerve Stimulator is classified as a Class II medical device in the United States and is listed under the FDA’s 510(k) pathway. The company is based in the US, where its devices are subject to regulatory oversight through the FDA’s medical device authorization processes.
Catalogue
- Registry: GUDID
Evala Nerve Stimulator (EPNR002) Ref K253536
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3026023106
- DUNS number
- 208240384
- Address
- 1875 Buckhorn Gate, Mississauga Ontario
- [email protected]
- Phone
- 9052060466
Frequently asked questions
How many devices does Epineuron Technologies, Inc. have in the registry?
The registry currently lists 2 devices for Epineuron Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Epineuron Technologies, Inc.'s devices?
Among its 2 most recently registered devices, Epineuron Technologies, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Epineuron Technologies, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Epineuron Technologies, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Epineuron Technologies, Inc. in the registry?
The most recently registered devices listed for Epineuron Technologies, Inc. include Evala nerve stimulator EPNR002 and Evala Nerve Stimulator (EPNR002).