510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K903510Substantially Equivalent

Mickey/minnie Mouse Batt. Operate Toothbrush

Helm Toy Corp., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903510 is the FDA 510(k) clearance record for MICKEY/MINNIE MOUSE BATT. OPERATE TOOTHBRUSH, a class I device, cleared for Helm Toy Corp. on under FDA product code JEQ (Toothbrush, Powered). FDA records list one 510(k) clearance for Helm Toy Corp. As of , FDA records show no recalls naming K903510.

Clearance record

Decision date
Received
(38 days to decision)
Product code
JEQ Toothbrush, Powered
Regulation
21 CFR 872.6865
Device class
Class I
Review panel
Dental
Applicant
Helm Toy Corp. C/O Follick & Bessich, P.C., New York NY
Third party review
No

Clearances, product code JEQ

Trailing 12 months

FDA records hold no clearances under product code JEQ in the trailing twelve months.

FDA records show no clearances under product code JEQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JEQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260