• 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 K861895
Device Name UNI-TENS
Applicant
SOLCOOR, INC.
1655 N. FT. MYER DR. STE. 700
ARLINGTON,  VA  22209
Applicant Contact BARBARA MARSDEN
Correspondent
SOLCOOR, INC.
1655 N. FT. MYER DR. STE. 700
ARLINGTON,  VA  22209
Correspondent Contact BARBARA MARSDEN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received05/16/1986
Decision Date 09/09/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-