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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Powered Inflatable Tube
510(k) Number K230500
Device Name Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401)
Applicant
Jiangsu Maxf Electric Appliance Co., Ltd.
#12, W. Park Rd., Rulin Town
Jintan District
Changzhou,  CN 213200
Applicant Contact Zhang Jianfang
Correspondent
Share Info (Guangzhou) Medical Consultant , Ltd.
# 1919-1920, Bldg. D3, Minjie Plaza,
Shuixi Rd., Huangpu District
Guangzhou,  CN 510000
Correspondent Contact Cassie Lee
Regulation Number890.5650
Classification Product Code
IRP  
Date Received02/24/2023
Decision Date 10/26/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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