Cleared Traditional

THE SIGNATURE SERIES, MAGNUM 100

K934919 · Progressive Electrical Therapeutics · Physical Medicine

Apr 1994

Decision

174d

Days

Class 2

Risk

About This 510(k) Submission

K934919 is an FDA 510(k) clearance for the THE SIGNATURE SERIES, MAGNUM 100, 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 April 6, 1994, 174 days after receiving the submission on October 14, 1993. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K934919 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 14, 1993
Decision Date	April 06, 1994
Days to Decision	174 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement