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Helius Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K253061Portable Neuromodulation Stimulator (PoNS)May 13, 2026
DEN200050Portable Neuromodulation Stimulator (PoNS)March 26, 2021