Omron Travel Toothbrush, Model HT-B02

Q: What is the product code of K901963?

The FDA product code is JEQ – Toothbrush, Powered, a Class I (low risk) device regulated under 21 CFR 872.6865.

FDA 510(k) K901963 · Omron Marshall Products, Inc.

Substantially Equivalent

510(k) numberK901963

Submission

Device name: Omron Travel Toothbrush, Model HT-B02
Applicant: Omron Marshall Products, Inc.
Lincolnshire, IL, US
Received: May 1, 1990
Decision date: June 26, 1990
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: JEQ – Toothbrush, Powered
Device class: Class I (low risk)
Regulation: 21 CFR 872.6865
Specialty: Dental

Other 510(k)s with product code JEQ

510(k)	Device	Applicant	Decision
K200881	Oral-B iO Test Drive Power Brush Trial Program KitJEQ · Traditional	The Procter & Gamble Company	08/27/2020SE
K141018	Oral-B Test Drive Power Brush Trial Program Kit, Oral-B Test Drive Power Toothbrush Kit…JEQ · Traditional	Procter & Gamble Co.	09/15/2014SE
K061351	Oral-B Sonic CompleteJEQ · Traditional	Braun GmbH	06/05/2006SE
K061199	Oral B Professionalcare Series, Oral B Advancepower SeriesJEQ · Traditional	Braun GmbH	05/31/2006SE
K040416	Sonicare Advance Toothbrush, Model 4900JEQ · Traditional	Philips Oral Healthcare, Inc.	07/02/2004SE
K022900	Butler Gum Vari-Clean Power ToothbrushesJEQ · Traditional	John O. Butler Co.	11/14/2002SE
K012914	Sonicwave Sonic Plaque RemoverJEQ · Traditional	Homedics, Inc.	10/01/2001SE
K970381	Powered ToothbrushJEQ · Traditional	Emjoi Action USA, Ltd.	04/18/1997SE
K943942	Trav-Ler KitJEQ · Traditional	John O. Butler Co.	03/08/1995SESK
K945248	Hukuba Hyg Electric Ionic ToothbrushJEQ · Traditional	Hukuba Dental Corp.	01/26/1995SE

More from Hukuba Dental Corp.

510(k)	Device	Decision
K903133	Omron Oscillometric Digital BP MONITOR-HEM-405CDXN · Traditional	01/18/1991SE
K903134	Omron Auto Oscillometric Dig BP MONT/HEM-704C 705CDXN · Traditional	01/08/1991SE

Questions and answers

When was Omron Travel Toothbrush, Model HT-B02 cleared by the FDA?

Omron Travel Toothbrush, Model HT-B02 (K901963) received a 510(k) decision of Substantially Equivalent on June 26, 1990, 56 days after the submission was received.

What is the product code of K901963?

The FDA product code is JEQ – Toothbrush, Powered, a Class I (low risk) device regulated under 21 CFR 872.6865.