Cleared Traditional

THE SIGNATURE SERIES, IC II

K933196 · Progressive Electrical Therapeutics · Physical Medicine

Jul 1994

Decision

376d

Days

Class 2

Risk

About This 510(k) Submission

K933196 is an FDA 510(k) clearance for the THE SIGNATURE SERIES, IC II, 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 12, 1994, 376 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	K933196 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 01, 1993
Decision Date	July 12, 1994
Days to Decision	376 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement