OMBRON TWIN-HEAD MASSAGER MODEL HM-101

Massager, Therapeutic, Electric

OMRON HEALTHCARE, INC.

The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Ombron Twin-head Massager Model Hm-101.

Pre-market Notification Details

Device IDK935462
510k NumberK935462
Device Name:OMBRON TWIN-HEAD MASSAGER MODEL HM-101
ClassificationMassager, Therapeutic, Electric
Applicant OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills,  IL  60061
ContactFrank Brichetto
CorrespondentFrank Brichetto
OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills,  IL  60061
Product CodeISA  
CFR Regulation Number890.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-11-12
Decision Date1994-03-04

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