FDA.reportPublic FDA data

HELIUS MEDICAL, INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30152598563015259856HELIUS MEDICAL, INC1N2026-01-01642 Newtown Yardley Rd. Suite 100 Newtown PA US 18940

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00864288000431PoNS - PoNS Mouthpiece8336131175support@heliusmedical.com
00864288000448PoNS - PoNS Controller833-613-1175support@heliusmedical.com
00864288000462PoNS - PoNS System8336131175support@heliusmedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2269951199757920DEN200050Portable Neuromodulation Stimulator (PoNS)QCF2021-03-26
2269951261575037

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QCF12021-03-26

GUDID#