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 Stimulator, Muscle, Powered
510(k) Number K041390
Device Name DIAMOND MEDISTIM
Applicant
Diamond Systems USA, Inc.
Unit C, 1 Madison St.
East Rutherford,  NJ  07073
Applicant Contact DONNA LOPE
Correspondent
Diamond Systems USA, Inc.
Unit C, 1 Madison St.
East Rutherford,  NJ  07073
Correspondent Contact DONNA LOPE
Regulation Number890.5850
Classification Product Code
IPF  
Date Received05/25/2004
Decision Date 02/09/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-