Cleared Traditional

K053041 - MED SCULPT

K053041 is an FDA 510(k) clearance for MED SCULPT, 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 279-day FDA review.

K053041 · General Project S.R.L. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
279d
Days
Class 2
Risk

K053041 is an FDA 510(k) clearance for the MED SCULPT. 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 August 2, 2006 after a review of 279 days - an extended review cycle.

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. Standard predicate reliance. 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.

View all General Project S.R.L. devices

FDA 510(k) Submission Details - K053041

510(k) Number K053041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2005
Decision Date August 02, 2006
Days to Decision 279 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
164d slower than avg
Panel avg: 115d · This submission: 279d
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.

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All 39
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