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 K123076
Device Name PROFTHAND MECHANICAL WHEELCHAIR
Applicant
Harmony Hill International
Rm. 1068, 10f, H Bldg. Of Nksp, #3-2
Park St., Nangang Dist
Taipei,  TW 11503
Applicant Contact TINA LAI
Correspondent
Harmony Hill International
Rm. 1068, 10f, H Bldg. Of Nksp, #3-2
Park St., Nangang Dist
Taipei,  TW 11503
Correspondent Contact TINA LAI
Regulation Number890.3850
Classification Product Code
IOR  
Date Received10/01/2012
Decision Date 08/09/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-