Cleared Traditional

THE SIGNATURE SERIES, M IV

K933197 · Progressive Electrical Therapeutics · Neurology
Jun 1995
Decision
701d
Days
Class 2
Risk

About This 510(k) Submission

K933197 is an FDA 510(k) clearance for the THE SIGNATURE SERIES, M IV, a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by Progressive Electrical Therapeutics (Nevada, US). The FDA issued a Cleared decision on June 2, 1995, 701 days after receiving the submission on July 1, 1993. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K933197 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1993
Decision Date June 02, 1995
Days to Decision 701 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code GZJ — Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5890

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