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510(k) K102524

FUTURA by Dr. Oliver Wenker, M.D., M.B.A. — Product Code IMG

K102524 is an FDA 510(k) premarket notification submitted by Dr. Oliver Wenker, M.D., M.B.A. for the device "FUTURA". The FDA issued a decision of Substantially Equivalent on November 3, 2011. The device falls under product code IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5860.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2011
Date Received
September 2, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5860
Review Panel
PM
Submission Type

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FDA data resources