Cleared Traditional

THE SIGNATURE SERIES, IC IV

K933195 · Progressive Electrical Therapeutics · Physical Medicine
Feb 1994
Decision
237d
Days
Class 2
Risk

About This 510(k) Submission

K933195 is an FDA 510(k) clearance for the THE SIGNATURE SERIES, IC 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 February 23, 1994, 237 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 K933195 FDA.gov
FDA Decision Cleared SN
Date Received July 01, 1993
Decision Date February 23, 1994
Days to Decision 237 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary

Device Classification

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