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 K860159
Device Name THUMPER (VIBRATOR/MASSAGER)
Applicant
Wellness Innovations Corp.
124 Denison St., #40
Markham, Ontario
Canada L3r 4b5,  CA
Applicant Contact ED NOBLE
Correspondent
Wellness Innovations Corp.
124 Denison St., #40
Markham, Ontario
Canada L3r 4b5,  CA
Correspondent Contact ED NOBLE
Regulation Number890.5975
Classification Product Code
IRO  
Date Received01/16/1986
Decision Date 02/06/1986
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
-
-