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 Wheelchair, Mechanical
510(k) Number K153328
Device Name SUNCO Mechanical Wheelchair, model SKW-9003
Applicant
DANYANG SUNCO MACHINERY CO., LTD
TAOJING ROAD, OPTICS INDUSTRIAL PARK, SITU TOWN
DANYANG CITY,  CN 212300
Applicant Contact JEN KE-MIN
Correspondent
DANYANG SUNCO MACHINERY CO., LTD
TAOJING ROAD, OPTICS INDUSTRIAL PARK, SITU TOWN
DANYANG CITY,  CN 212300
Correspondent Contact JEN KE-MIN
Regulation Number890.3850
Classification Product Code
IOR  
Date Received11/19/2015
Decision Date 07/20/2016
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
-
-