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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 K201935
Device Name Air Pressure Therapy System
Applicant
Xiamen Weiyou Intelligent Technology Co., Ltd.
Unit 101-401,#6 Xianghong Rd.,Xiang'An District
Xiamen,  CN 361021
Applicant Contact Yong Sun
Correspondent
Shanghai Spica Management Consulting Co., Ltd.
609 Rm., # 133 Shengang Ave., Pudong New District
Shanghai,  CN 201306
Correspondent Contact Sam Lin
Regulation Number890.5650
Classification Product Code
IRP  
Date Received07/13/2020
Decision Date 06/22/2021
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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