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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 K253919
Device Name Cryo And Thermo Therapy System
Applicant
Xiamen Weiyou Intelligent Technology Co., Ltd.
Unit 301 # 6 Xianghong Rd.,
Torch Hi-Tech Zone Industrial Park, Xiang'An District
Xiamen,  CN
Applicant Contact Kelly Guo
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Eva Li
Regulation Number890.5650
Classification Product Code
IRP  
Subsequent Product Code
ILO  
Date Received12/08/2025
Decision Date 06/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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