510(k) K020032

APEX MEDICAL MINI TENS by Apex Medical Corp. — Product Code GZJ

K020032 is an FDA 510(k) premarket notification submitted by Apex Medical Corp. for the device "APEX MEDICAL MINI TENS". The FDA issued a decision of Substantially Equivalent on January 31, 2002. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Apex Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2002
Date Received
January 4, 2002
Clearance Type
Special
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