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, Nerve, Transcutaneous, For Pain Relief
510(k) Number K883188
Device Name T.E.N.S. UNIT SIGMA & TX-3
Applicant
Diamond Medical Equipment, Inc.
95-40 157th St.
Jamaica,  NY  11433
Applicant Contact HARVEY DIAMOND
Correspondent
Diamond Medical Equipment, Inc.
95-40 157th St.
Jamaica,  NY  11433
Correspondent Contact HARVEY DIAMOND
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received07/28/1988
Decision Date 12/16/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-