meddevicedb.com FDA Device Reference

Portable Neuromodulation Stimulator (PoNS)

DEN200050 Class II Direct
Decision Date
2021-03-26
Sponsor / Applicant
Helius Medical, Inc.

Technical Specification

510(k) Submission ID DEN200050
Product Code QCF
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.5889
Decision Date 2021-03-26
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Portable Neuromodulation Stimulator (PoNS) received FDA 510(k) clearance under submission number DEN200050, sponsored by Helius Medical, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2021-03-26.

Classification & Regulation

This clearance is catalogued under FDA product code QCF and 21 CFR 882.5889, within the Neurology review panel as a Class II device.