510(k) K850004

TRANSCUTANEOUS NERVE STIMULATOR FOR PAIN RELIEF by Todd Medical, Inc. — Product Code GZJ

K850004 is an FDA 510(k) premarket notification submitted by Todd Medical, Inc. for the device "TRANSCUTANEOUS NERVE STIMULATOR FOR PAIN RELIEF". The FDA issued a decision of Substantially Equivalent on April 2, 1985. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Todd Medical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1985
Date Received
January 2, 1985
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