Cleared Traditional

FUTURA

K102524 · Dr. Oliver Wenker, M.D., M.B.A. · Physical Medicine

Nov 2011

Decision

427d

Days

Class 2

Risk

About This 510(k) Submission

K102524 is an FDA 510(k) clearance for the FUTURA, a Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (Class II — Special Controls, product code IMG), submitted by Dr. Oliver Wenker, M.D., M.B.A. (Farmers Branch, US). The FDA issued a Cleared decision on November 3, 2011, 427 days after receiving the submission on September 2, 2010. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5860.

Submission Details

510(k) Number	K102524 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 02, 2010
Decision Date	November 03, 2011
Days to Decision	427 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF

Device Classification

Product Code	IMG — Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 890.5860