510(k) K933197

THE SIGNATURE SERIES, M IV by Progressive Electrical Therapeutics — Product Code GZJ

K933197 is an FDA 510(k) premarket notification submitted by Progressive Electrical Therapeutics for the device "THE SIGNATURE SERIES, M IV". The FDA issued a decision of Substantially Equivalent on June 2, 1995. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Progressive Electrical Therapeutics has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1995
Date Received
July 1, 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