510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K901963Substantially Equivalent

Omron Travel Toothbrush, Model Ht-B02

Omron Marshall Products, Inc., Lincolnshire IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901963 is the FDA 510(k) clearance record for OMRON TRAVEL TOOTHBRUSH, MODEL HT-B02, a class I device, cleared for Omron Marshall Products, Inc. on under FDA product code JEQ (Toothbrush, Powered). FDA records list 3 510(k) clearances for Omron Marshall Products, Inc., from to . As of , FDA records show no recalls naming K901963.

Clearance record

Decision date
Received
(56 days to decision)
Product code
JEQ Toothbrush, Powered
Regulation
21 CFR 872.6865
Device class
Class I
Review panel
Dental
Applicant
Omron Marshall Products, Inc. 600 Barclay Blvd., Lincolnshire IL
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