510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253061Substantially Equivalent

Portable Neuromodulation Stimulator (PoNS)

Helius Medical, Inc, Newton PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253061 is the FDA 510(k) clearance record for Portable Neuromodulation Stimulator (PoNS), a class II device, cleared for Helius Medical, Inc. on under FDA product code QCF (Electrical Tongue Stimulator To Treat Motor Deficits). FDA's definition for product code QCF reads: "An electrical tongue nerve stimulator to treat motor deficits is a prescription device that consists of a non-implantable apparatus to generate electrical pulses for stimulation of the nerves in the tongue to provide treatment of motor...". FDA records list 2 510(k) clearances for Helius Medical, Inc., from to . As of , FDA records show no recalls naming K253061.

Clearance record

Decision date
Received
(233 days to decision)
Product code
QCF Electrical Tongue Stimulator To Treat Motor Deficits
Regulation
21 CFR 882.5889
Device class
Class II
Review panel
Neurology
Applicant
Helius Medical, Inc. 642 Newtown Yardley Rd. Suite 100, Newton PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QCF

Trailing 12 months
1 clearance under product code QCF in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QCF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260