Pressure Therapy System PT1003

Massager, Powered Inflatable Tube

Xiamen Senyang Co., Ltd.

The following data is part of a premarket notification filed by Xiamen Senyang Co., Ltd. with the FDA for Pressure Therapy System Pt1003.

Pre-market Notification Details

Device IDK192358
510k NumberK192358
Device Name:Pressure Therapy System PT1003
ClassificationMassager, Powered Inflatable Tube
Applicant Xiamen Senyang Co., Ltd. 4-5 Floor, Xingbei Industry, No 95-99, West 2 Road Jiu Tianhu Xinglin Xiamen,  CN 361000
ContactNina Cai
CorrespondentRaymond Luo
Shanghai SUNGO Management Consultanting Co., Ltd. 13th F, 1500# Century Avenue Shanghai,  CN 200122
Product CodeIRP  
CFR Regulation Number890.5650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-29
Decision Date2020-04-23

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