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 K032505
Device Name AIR PRESS MASSAGER
Applicant
Telebrands Corp
1776 K St., NW
Suite 800
Washington,  DC  20006
Applicant Contact DONALD E SEGAL
Correspondent
Telebrands Corp
1776 K St., NW
Suite 800
Washington,  DC  20006
Correspondent Contact DONALD E SEGAL
Regulation Number890.5650
Classification Product Code
IRP  
Date Received08/13/2003
Decision Date 09/24/2003
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
-
-