FDA.report

510(k) K201982

Device
Air Compression Therapy System FO-3001; Air Compression Therapy System FO-3008
Applicant
Foshan Hongfeng Co., Ltd
510(k) number
K201982
Product code
IRP  
Decision
Substantially Equivalent (SESE)
Decision date
2021-03-25
Date received
2020-07-17
Regulation
890.5650
Classification name
Massager, Powered Inflatable Tube
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Cheng Dongfeng
Address
#4-2 Leqiang Rd., Leping Sanshui Foshan CN 528000 528000

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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Legacy Summary

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FDA Review

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