Air Compression Therapy System FO-3001; Air Compression Therapy System FO-3008

Massager, Powered Inflatable Tube

Foshan Hongfeng Co., Ltd

The following data is part of a premarket notification filed by Foshan Hongfeng Co., Ltd with the FDA for Air Compression Therapy System Fo-3001; Air Compression Therapy System Fo-3008.

Pre-market Notification Details

Device IDK201982
510k NumberK201982
Device Name:Air Compression Therapy System FO-3001; Air Compression Therapy System FO-3008
ClassificationMassager, Powered Inflatable Tube
Applicant Foshan Hongfeng Co., Ltd No.4-2 Leqiang Road, Leping Sanshui Foshan,  CN 528000
ContactCheng Dongfeng
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 Received2020-07-17
Decision Date2021-03-25

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