Helius Medical, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Helius Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Portable Neuromodulation Stimulator (PoNS)
2
Total
1
Cleared
1
Denied
Helius Medical, Inc. has 1 FDA 510(k) cleared medical devices. Based in Newtown, US.
Latest FDA clearance: May 2026. Active since 2021. Primary specialty: Neurology.
Browse the FDA 510(k) cleared devices submitted by Helius Medical, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Helius Medical, Inc.
2 devices