Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015259856

FEI Number

3015259856

Entity Name

HELIUS MEDICAL, INC

City/State/Country

Newtown, PA, US

Establishment Address

642 Newtown Yardley Rd., Suite 100, Newtown, PA 18940, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Helius Medical, Inc (Owner Number: 10059664)

Owner / Operator Contact Address

642 Newtown Yardley Rd., Suite 100, Newtown, PA 18940, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN200050

PMA Number

N/A

All Registered Proprietary Names

Portable Neuromodulation Stimulator (PoNS)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QCF	Electrical Tongue Stimulator To Treat Motor Deficits	Neurology	Class 2	882.5889	2021-04-22

Official Correspondent

Lawrence Picciano

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Helius Medical, Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3036471706	BIONESS MEDICAL, INC.	Valencia, CA, US
3028606342	OMAY(GUANGZHOU) MED TECHNOLOGIES CO., LTD	Guangzhou Guangdong, CN
3038274470	BRAINMATTERZ, INC	McKinney, TX, US
3012404174	LABORATORIO CHIMICO FARMACEUTICO A. SELLA SRL.	Schio Vicenza, IT
3042364673	NEURALYTIX LLC	Fruita, CO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015259856. Last updated year: 2026. Please use registration number 3015259856 when referencing this establishment in official correspondence.