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 K001391
Device Name BONUS MECHANICAL WHEELCHAIR
Applicant
BONUS ENT. CORP.
228 LAKE MERCED HILL
SAN FRANCISCO,  CA  94132
Applicant Contact JEFF TEPERMEYSTER
Correspondent
BONUS ENT. CORP.
228 LAKE MERCED HILL
SAN FRANCISCO,  CA  94132
Correspondent Contact JEFF TEPERMEYSTER
Regulation Number890.3850
Classification Product Code
IOR  
Date Received05/02/2000
Decision Date 07/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-