Helius Medical Inc

FDA Filings

This page includes the latest FDA filings for Helius Medical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3015259856
FEI Number3015259856
NameHELIUS MEDICAL, INC
Owner & OperatorHelius Medical, Inc
Contact Address642 Newtown Yardley Rd. Suite 100
Newtown PA 18940 US
Official Correspondent
  • Lawrence Picciano
  • x-215-9446035-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address642 Newtown Yardley Rd. Suite 100
Newtown, PA 18940 US
Establishment TypeManufacture Device in the United States for Export Only



FDA Filings

Device
Company
DeviceDate
Helius Medical, Inc
PoNS S1-001-022022-06-28
Helius Medical, Inc
PoNS M1-0012022-05-10
Helius Medical, Inc.
Portable Neuromodulation Stimulator (PoNS)2021-03-26
HELIUS MEDICAL, INC
PoNS2020-02-27

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