RELAXU-1

Massager, Therapeutic, Electric

KINSEI SHIATSU, INC.

The following data is part of a premarket notification filed by Kinsei Shiatsu, Inc. with the FDA for Relaxu-1.

Pre-market Notification Details

Device IDK950411
510k NumberK950411
Device Name:RELAXU-1
ClassificationMassager, Therapeutic, Electric
Applicant KINSEI SHIATSU, INC. 22138 SOUTH VERMONT AVE. UNIT F Torrance,  CA  90502
ContactKoji Nishida
CorrespondentKoji Nishida
KINSEI SHIATSU, INC. 22138 SOUTH VERMONT AVE. UNIT F Torrance,  CA  90502
Product CodeISA  
CFR Regulation Number890.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-01-31
Decision Date1995-08-02

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