Cleared Traditional

THE SIGNATURE SERIES, IMC IV

K933194 · Progressive Electrical Therapeutics · Physical Medicine
Jul 1994
Decision
377d
Days
Class 2
Risk

About This 510(k) Submission

K933194 is an FDA 510(k) clearance for the THE SIGNATURE SERIES, IMC IV, a Stimulator, Muscle, Powered (Class II — Special Controls, product code IPF), submitted by Progressive Electrical Therapeutics (Nevada, US). The FDA issued a Cleared decision on July 13, 1994, 377 days after receiving the submission on July 1, 1993. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number K933194 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1993
Decision Date July 13, 1994
Days to Decision 377 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code IPF — Stimulator, Muscle, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5850