510(k) K030375

SOFT-TOUCH TENS ELECTRODE by Pain Management Technologies — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2003
Date Received
February 4, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type