Air Pressure Foot Massager

Massager, Powered Inflatable Tube

Xiamen Simo Electronic Co., Ltd

The following data is part of a premarket notification filed by Xiamen Simo Electronic Co., Ltd with the FDA for Air Pressure Foot Massager.

Pre-market Notification Details

Device IDK212935
510k NumberK212935
Device Name:Air Pressure Foot Massager
ClassificationMassager, Powered Inflatable Tube
Applicant Xiamen Simo Electronic Co., Ltd Floor 3rd-5th, No. 173 Siming Park, Tong'an Industrial Zone, Tong'an District Xia Men,  CN 361100
ContactWang Qinsheng
CorrespondentRay Wang
Beijing Believe-Med Technology Service Co., Ltd. Rm. 912, Building #15, XiYueHui, No.5, YiHe North RD., FangShan District Beijing,  CN 102401
Product CodeIRP  
CFR Regulation Number890.5650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-15
Decision Date2022-02-19

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