Data / Medical devices / United States / Helius Medical, Inc

Helius Medical, Inc: FDA-registered device maker in Newtown, PA, United States, 1 510(k) clearance

Helius Medical, Inc is registered with the FDA (registration 3015259856) in Newtown, PA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 26, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number

3015259856

Address

642 Newtown Yardley Rd. Suite 100, Newtown, PA, United States, 18940

Owner or operator

Helius Medical, Inc (10059664)

Roles

Complaint file establishment, Manufacturer, Specification developer

First device listed

April 22, 2021

Registered through

2026

Brand names listed

Portable Neuromodulation Stimulator (PoNS)

Devices it lists

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Updated March 26, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.