Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

POWERED TOOTHBRUSH

K-Number: K970381 · 1997-04-18

ApplicantEmjoi Action USA, Ltd.
Decision Date1997-04-18
Product CodeJEQ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

POWERED TOOTHBRUSH is the device name listed in this FDA 510(k) record. The listed applicant is Emjoi Action USA, Ltd.. It received FDA 510(k) clearance on 1997-04-18 under 510(k) number K970381. The device is classified under product code JEQ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWERED TOOTHBRUSH?

POWERED TOOTHBRUSH is a medical device that received FDA 510(k) clearance on 1997-04-18. The listed applicant is Emjoi Action USA, Ltd.. The 510(k) number is K970381.

When did POWERED TOOTHBRUSH receive FDA 510(k) clearance?

POWERED TOOTHBRUSH received FDA 510(k) clearance on 1997-04-18, under 510(k) number K970381.

Who is the listed applicant for POWERED TOOTHBRUSH?

The FDA 510(k) record lists Emjoi Action USA, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWERED TOOTHBRUSH?

The FDA product code for POWERED TOOTHBRUSH is JEQ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: JEQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200881Oral-B iO Test Drive Power Brush Trial Program KitThe Procter & Gamble CompanyK061351ORAL-B SONIC COMPLETEBraun GmbHK061199ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIESBraun GmbHK040416SONICARE ADVANCE TOOTHBRUSH, MODEL 4900Philips Oral Healthcare, Inc.K022900BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHESJohn O. Butler Co.K012914SONICWAVE SONIC PLAQUE REMOVERHomedics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑