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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 K223464
Device Name Leg and Foot Air Wave Pressure Therapy Device
Zhangzhou Easepal Innovation Co Ltd.
No.36 Longkun Road, Hongjian Village, Jiaomei Town,
Zhangzhou, Taiwanese Investment Zone
Zhangzhou,  CN 363000
Applicant Contact Xu Zibing
Guangzhou KEDA Biological Tech Co., Ltd.
6F, No.1 TianTai road, Science City, LuoGang District
GuangZhou City, China
Guangzhou,  CN 510000
Correspondent Contact Jet Li
Regulation Number890.5650
Classification Product Code
Date Received11/17/2022
Decision Date 03/14/2023
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