Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Electrical Tongue Stimulator To Treat Motor Deficits
510(k) Number K253061
Device Name Portable Neuromodulation Stimulator (PoNS)
Applicant
Helius Medical, Inc.
642 Newtown Yardley Rd. Suite 100
Newton,  PA  18940
Applicant Contact Lawrence Picciano
Correspondent
Helius Medical, Inc.
642 Newtown Yardley Rd. Suite 100
Newton,  PA  18940
Correspondent Contact Lawrence Picciano
Classification Product Code
QCF  
Date Received09/22/2025
Decision Date 05/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-