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 K193354
Device Name Air Compression Therapy Device
Applicant
Shenzhen Dongjilian Electronics Co.,Ltd.
B1/1-5F, Tonglu Industrial Area, Tongxin Community
Longgang District
Shenzhen,  CN 518116
Applicant Contact Zhang Hong
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co Ltd
Room 2012#, Gebu commercial building, Hongxing community,
Songgang street
Shenzhen,  CN 518105
Correspondent Contact Reanny Wang
Regulation Number890.5650
Classification Product Code
IRP  
Date Received12/04/2019
Decision Date 06/08/2020
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
-
-