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 K010209
Device Name ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL
Applicant
BIOMEDICAL LIFE SYSTEMS, INC.
P.O. BOX 1360
VISTA,  CA  92085 -1360
Applicant Contact RICHARD SAXON
Correspondent
BIOMEDICAL LIFE SYSTEMS, INC.
P.O. BOX 1360
VISTA,  CA  92085 -1360
Correspondent Contact RICHARD SAXON
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received01/23/2001
Decision Date 06/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-