Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Massager, Powered Inflatable Tube
510(k) Number K161907
Device Name Pressure Therapy System
Applicant
Xiamen Senyang Co., Ltd.
4-5 Floor, Xingbei Industry, No 95-99, W. 2 Rd.
Jiu Tianhu
Xinglin Xiamen,  CN 361000
Applicant Contact XINJIE SHAO
Correspondent
Shanghai Sungo Management Consulting Company Limited.
4th Floor, 1500# Central Ave.
Shanghai,  CN 200122
Correspondent Contact RAYMOND LUO
Regulation Number890.5650
Classification Product Code
IRP  
Date Received07/12/2016
Decision Date 02/23/2017
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
-
-