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 Number: 3015259856
• FEI Number: 3015259856
• Name: HELIUS MEDICAL, INC
• Owner & Operator: Helius Medical, Inc
• Contact Address: 642 Newtown Yardley Rd. Suite 100; Newtown PA 18940 US
• Official Correspondent:
  • Lawrence Picciano
  • x-215-9446035-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 642 Newtown Yardley Rd. Suite 100; Newtown, PA 18940 US
• Establishment Type: Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
GUDID 00864288000448 Helius Medical, Inc	PoNS CP-002	2024-10-08
GUDID 00864288000462 Helius Medical, Inc	PoNS S1-001-02	2022-06-28
GUDID 00864288000431 Helius Medical, Inc	PoNS M1-001	2022-05-10
De Novo DEN200050 Helius Medical, Inc.	Portable Neuromodulation Stimulator (PoNS)	2021-03-26
IRO HELIUS MEDICAL, INC	PoNS	2020-02-27