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, Powered Inflatable Tube
510(k) Number K040905
Device Name WELLNESS/JOLIVETE
Applicant
Tohkai Precision Ind. , Ltd.
2840 Scherer Dr. N.
Saint Petersburg,  FL  33716
Applicant Contact ROBERT T WAGNER
Correspondent
Tohkai Precision Ind. , Ltd.
2840 Scherer Dr. N.
Saint Petersburg,  FL  33716
Correspondent Contact ROBERT T WAGNER
Regulation Number890.5650
Classification Product Code
IRP  
Date Received04/07/2004
Decision Date 02/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-