510(k) K933237

MEDI-STIM, MODIFICATION by Mid-Canada Medical — Product Code GZJ

K933237 is an FDA 510(k) premarket notification submitted by Mid-Canada Medical for the device "MEDI-STIM, MODIFICATION". The FDA issued a decision of Substantially Equivalent on September 8, 1994. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Mid-Canada Medical has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1994
Date Received
June 24, 1993
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