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 K094047
Device Name 18 STANDARD WHEELCHAIR, MODEL MS005-4, 18 RECLINING WHEELCHAIR , MODEL MS008-1, 14 PEDIATRIC WHEELCHAIR
Applicant
Modern Rehabilitation Solutions Co., Ltd.
5401 S Cottonwood Ct.
Greenwood Village,  CO  80121
Applicant Contact Kevin Walls
Correspondent
Modern Rehabilitation Solutions Co., Ltd.
5401 S Cottonwood Ct.
Greenwood Village,  CO  80121
Correspondent Contact Kevin Walls
Regulation Number890.3850
Classification Product Code
IOR  
Date Received12/31/2009
Decision Date 03/22/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-