SPIN ROLLERE

Massager, Therapeutic, Electric

KINSEI SHIATSU, INC.

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

Pre-market Notification Details

Device IDK952990
510k NumberK952990
Device Name:SPIN ROLLERE
ClassificationMassager, Therapeutic, Electric
Applicant KINSEI SHIATSU, INC. 22138 SOUTH VERMONT AVE. UNIT F Torrance,  CA  90502
ContactHaru Ishimoto
CorrespondentHaru Ishimoto
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 Received1995-06-28
Decision Date1995-09-29

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