510(k) K934919

THE SIGNATURE SERIES, MAGNUM 100 by Progressive Electrical Therapeutics — Product Code IPF

K934919 is an FDA 510(k) premarket notification submitted by Progressive Electrical Therapeutics for the device "THE SIGNATURE SERIES, MAGNUM 100". The FDA issued a decision of Substantially Equivalent on April 6, 1994. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Progressive Electrical Therapeutics has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1994
Date Received
October 14, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type