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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 K192358
Device Name Pressure Therapy System PT1003
Applicant
Xiamen Senyang Co., Ltd.
4-5 Floor, Xingbei Industry, No 95-99, W. 2 Rd.
Jiu Tianhu
Xinglin Xiamen,  CN 361000
Applicant Contact Nina Cai
Correspondent
Shanghai Sungo Management Consultanting Co., Ltd.
13th F, 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Raymond Luo
Regulation Number890.5650
Classification Product Code
IRP  
Date Received08/29/2019
Decision Date 04/23/2020
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
Recalls CDRH Recalls
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