510(k) K993229

ANALGESIC PULSER, MODEL AP-439 by Johari Electro-Tech Co. — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 2001
Date Received
September 27, 1999
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