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 Device, Iontophoresis, Other Uses
510(k) Number K993081
Device Name IO-DRIVE
Applicant
Selectivemed Components, Inc.
6 S. Mechanic St.
Mount Vernon,  OH  43050
Applicant Contact RICK FISHER
Correspondent
Selectivemed Components, Inc.
6 S. Mechanic St.
Mount Vernon,  OH  43050
Correspondent Contact RICK FISHER
Regulation Number890.5525
Classification Product Code
EGJ  
Date Received09/15/1999
Decision Date 03/03/2000
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
-
-