RELAXY-THE WONDER HAND

Massager, Therapeutic, Electric

KINSEI SHIATSU, INC.

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

Pre-market Notification Details

Device IDK950322
510k NumberK950322
Device Name:RELAXY-THE WONDER HAND
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 For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-01-26
Decision Date1995-02-14

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