Medical Device Manufacturer · US , Newtown , PA

Helius Medical, Inc. - FDA 510(k) Cleared Devices

2 submissions · 1 cleared · Since 2021

Recent clearances: Portable Neuromodulation Stimulator (PoNS)

View 2 510(k) Devices ↓

2

Total

1

Cleared

1

Denied

FDA 510(k) Regulatory Record - Helius Medical, Inc. Neurology ✕

2 devices

1-2 of 2

Cleared May 13, 2026

Portable Neuromodulation Stimulator (PoNS)

Neurology · 233d

Not Cleared Mar 26, 2021

Portable Neuromodulation Stimulator (PoNS)

DEN200050 · QCF

Neurology · 234d