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 Stimulator, Neuromuscular, External Functional
510(k) Number K911066
Device Name COMFORTRON PT (TENS)
Applicant
M. D. Supply, Inc.
4720 SE Fort King St.
Ocala,  FL  32671
Applicant Contact RICHARD O VOGEL
Correspondent
M. D. Supply, Inc.
4720 SE Fort King St.
Ocala,  FL  32671
Correspondent Contact RICHARD O VOGEL
Regulation Number882.5810
Classification Product Code
GZI  
Date Received03/11/1991
Decision Date 02/07/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-