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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 K181409
Device Name Pressure Therapy System PT1003
Applicant
Xiamen Senyang Co., Ltd.
4-5 Floor, Xingbei Industry, No 95-99, West 2 Road
Jiu Tianhu
Xinglin Xiamen,  CN 361000
Applicant Contact Nina Cai
Correspondent
Shanghai Sungo Management Consulting Co., Ltd.
13th F, 1500# Century Avenue
Shanghai,  CN 200122
Correspondent Contact Raymond Luo
Regulation Number890.5650
Classification Product Code
IRP  
Date Received05/30/2018
Decision Date 02/19/2019
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
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