Helius Medical, Inc
United StatesFDA applicant, unverified FDA FEI 3015259856
- Devices
- 5
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Portable Neuromodulation Stimulator (PoNS) Ref K253061
Regimes: 510(k) Registry: 510(k)Portable Neuromodulation Stimulator (PoNS) Ref DEN200050
Regimes: De Novo Registry: De Novo
Company details
- FDA FEI number
- 3015259856
- DUNS number
- 079644962
- Address
- 642 Newtown Yardley Rd., Newtown, PA, 18940
- [email protected]
- Phone
- 8336131175
Frequently asked questions
How many devices does Helius Medical, Inc have in the registry?
The registry currently lists 5 devices for Helius Medical, Inc. Devices recorded under merged duplicate company entries are counted once.
Which registries list Helius Medical, Inc's devices?
Among its 5 most recently registered devices, Helius Medical, Inc has devices listed in FDA 510(k) (2 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Helius Medical, Inc's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Helius Medical, Inc's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Helius Medical, Inc in the registry?
The most recently registered devices listed for Helius Medical, Inc include PoNS 1.1 and Portable Neuromodulation Stimulator (PoNS).