510(k) K014126

SANIDAD HEALTH-UP TENS MP-73725 by Roc Chinese-European Industrial Research Society — Product Code GZJ

K014126 is an FDA 510(k) premarket notification submitted by Roc Chinese-European Industrial Research Society for the device "SANIDAD HEALTH-UP TENS MP-73725". The FDA issued a decision of Substantially Equivalent on May 3, 2002. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Roc Chinese-European Industrial Research Society has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2002
Date Received
December 17, 2001
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