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 Massager, Therapeutic, Electric
510(k) Number K863197
Device Name VIBROFLEX
Applicant
Stoffregen & Co., Inc.
104 S. Milton
Anaheim,  LA  92806
Applicant Contact ROBERT STOFFREGEN
Correspondent
Stoffregen & Co., Inc.
104 S. Milton
Anaheim,  LA  92806
Correspondent Contact ROBERT STOFFREGEN
Regulation Number890.5660
Classification Product Code
ISA  
Date Received08/19/1986
Decision Date 09/19/1986
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
-
-