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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 K253064
Device Name Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air Pressure Therapy System (VU-IPC4X)
Applicant
Xiamen Weiyou Intelligent Technology Co., Ltd.
Unit 101-401,#6 Xianghong Rd.,Xiang'An District
Xiamen,  CN 361021
Applicant Contact Kelly Guo
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave.,
Shanghai,  CN 200122
Correspondent Contact Ariel Xiang
Regulation Number890.5650
Classification Product Code
IRP  
Date Received09/22/2025
Decision Date 04/30/2026
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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