Air Compression Leg Massager HY-1117A

Massager, Powered Inflatable Tube

Xiamen High Top Electronic Technology Co., Ltd.

The following data is part of a premarket notification filed by Xiamen High Top Electronic Technology Co., Ltd. with the FDA for Air Compression Leg Massager Hy-1117a.

Pre-market Notification Details

Device IDK212713
510k NumberK212713
Device Name:Air Compression Leg Massager HY-1117A
ClassificationMassager, Powered Inflatable Tube
Applicant Xiamen High Top Electronic Technology Co., Ltd. F2-5 No. 118 Siming Park, Tong'an Industrial Zone Xiamen,  CN 361000
ContactLiangsan Zhao
CorrespondentSam Lin
Shanghai Spica Management Consulting Co., Ltd. 609 Room, No.133 Shengang Avenue, Pudong New District Shanghai,  CN 201306
Product CodeIRP  
CFR Regulation Number890.5650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-26
Decision Date2022-01-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10850023727074 K212713 000
10850023727050 K212713 000
10850023727043 K212713 000
10850023727036 K212713 000

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