Massage Compression Boots

Massager, Powered Inflatable Tube

JKH USA, LLC

The following data is part of a premarket notification filed by Jkh Usa, Llc with the FDA for Massage Compression Boots.

Pre-market Notification Details

Device IDK201645
510k NumberK201645
Device Name:Massage Compression Boots
ClassificationMassager, Powered Inflatable Tube
Applicant JKH USA, LLC 20505 Valley Blvd. Suite 108 Walnut,  CA  91789
ContactBill Quanqin Dai
CorrespondentBill Quanqin Dai
JKH USA, LLC 14271 Jeffrey Rd. #246 Irvine,  CA  92620
Product CodeIRP  
CFR Regulation Number890.5650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-17
Decision Date2020-09-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10311917137381 K201645 000

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