Powerpress Recovery Unit

Massager, Powered Inflatable Tube

Hanuri Distribution, Inc

The following data is part of a premarket notification filed by Hanuri Distribution, Inc with the FDA for Powerpress Recovery Unit.

Pre-market Notification Details

Device IDK202044
510k NumberK202044
Device Name:Powerpress Recovery Unit
ClassificationMassager, Powered Inflatable Tube
Applicant Hanuri Distribution, Inc 9601 Owensmouth Ave. # 8 Chatsworth,  CA  91311
ContactJung Hyun Moon
CorrespondentJung Hyun Moon
Hanuri Distribution, Inc 9601 Owensmouth Ave. # 8 Chatsworth,  CA  91311
Product CodeIRP  
CFR Regulation Number890.5650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-23
Decision Date2020-10-21

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