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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 K201694
Device Name Air Compression Therapy Device
Applicant
Shenzhen Dongjilian Electronics Co., Ltd.
B1/1-5f, Tonglu Industrial Area, Tongxin Community,
Longgang District
Shenzhen,  CN 518116
Applicant Contact Zhang Hong
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co., Ltd.
Rm. 2012#, Gebu Commercial Bldg., Hongxing Community
Songgang St.
Shenzhen,  CN 518105
Correspondent Contact Reanny Wang
Regulation Number890.5650
Classification Product Code
IRP  
Date Received06/22/2020
Decision Date 11/19/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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