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 K951037
Device Name AKISU FOLDING WHEELCHAIR, MODELS AW-900, 910, 920, 930, 950 AND AW-820, 830
Applicant
Akisu Machinery
# 137, Ching Niarn Rd.
Tachia Town
Tai-Chung Hsien,  TW 43719
Applicant Contact DAVID CHUNG
Correspondent
Akisu Machinery
# 137, Ching Niarn Rd.
Tachia Town
Tai-Chung Hsien,  TW 43719
Correspondent Contact DAVID CHUNG
Regulation Number890.3850
Classification Product Code
IOR  
Date Received03/07/1995
Decision Date 03/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-