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 Vibrator, Therapeutic
510(k) Number K913439
Device Name SONIX...THERAPEUTIC SONIC MASSAGE
Applicant
Mcshirley Products, Inc.
25169 Anza Dr.
Valencia,  CA  91355
Applicant Contact RICHARD MCSHIRLEY
Correspondent
Mcshirley Products, Inc.
25169 Anza Dr.
Valencia,  CA  91355
Correspondent Contact RICHARD MCSHIRLEY
Regulation Number890.5975
Classification Product Code
IRO  
Date Received08/02/1991
Decision Date 01/22/1992
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
-
-