Cleared Traditional

K091615 - MED CONTOUR

K091615 is an FDA 510(k) clearance for MED CONTOUR, manufactured by General Project S.R.L.. The device is a Class 2 Physical Medicine device with product code IMI cleared through the Traditional 510(k) pathway after a 337-day FDA review.

K091615 · General Project S.R.L. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
337d
Days
Class 2
Risk

K091615 is an FDA 510(k) clearance for the MED CONTOUR. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by General Project S.R.L. (North Reading, US). The FDA issued a Cleared decision on May 6, 2010 after a review of 337 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5300 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K091615

510(k) Number K091615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2009
Decision Date May 06, 2010
Days to Decision 337 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
221d slower than avg
Panel avg: 116d · This submission: 337d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IMI Device Classification - Class 2, Special Controls

Product Code IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

All 77
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K091615.
ACCUSONIC ADVANTAGE
K124010 · Metron Medical Australia, Pty, Ltd. · Aug 2013
ACCUSONIC ADVANTAGE
K120171 · Metron Medical Australia, Pty, Ltd. · May 2012
US-101L, US-103S
K112520 · Ito Co., Ltd. · Oct 2011
SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900
K090542 · Sun-Rain System Corp. · Oct 2009
HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM
K062256 · Hill Laboratories Co. · Feb 2007
MED SCULPT
K053041 · General Project S.R.L. · Aug 2006
K091615 · MED CONTOUR
Download PDF FDA Summary General Project S.R.L.