510(k) K142666

Scrambler Therapy MC-5 A Device by Delta International Services & Logistics S.R.L — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2015
Date Received
September 18, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type