The following data is part of a premarket notification filed by Xiamen Senyang Co., Ltd. with the FDA for Pressure Therapy System.
| Device ID | K161907 |
| 510k Number | K161907 |
| Device Name: | Pressure Therapy System |
| Classification | Massager, 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 |
| Contact | Xinjie Shao |
| Correspondent | Raymond Luo SHANGHAI SUNGO MANAGEMENT CONSULTING COMPANY LIMITED 4TH FLOOR 1500# CENTRAL AVENUE Shanghai, CN 200122 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-12 |
| Decision Date | 2017-02-23 |
| Summary: | summary |