Cleared Traditional

K903675 - MAGNETIC RESONANCE THERAPY DEVICE

K903675 is an FDA 510(k) clearance for MAGNETIC RESONANCE THERAPY DEVICE, manufactured by Mrt, Inc.. The device is a Class 2 Physical Medicine device with product code ILX cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K903675 · Mrt, Inc. · Physical Medicine device
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Jan 1991
Decision
157d
Days
Class 2
Risk

K903675 is an FDA 510(k) clearance for the MAGNETIC RESONANCE THERAPY DEVICE. Classified as Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat (product code ILX), Class II - Special Controls.

Submitted by Mrt, Inc. (Santa Monica, US). The FDA issued a Cleared decision on January 17, 1991 after a review of 157 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5290 - 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 Mrt, Inc. devices

FDA 510(k) Submission Details - K903675

510(k) Number K903675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1990
Decision Date January 17, 1991
Days to Decision 157 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 115d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILX Device Classification - Class 2, Special Controls

Product Code ILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5290
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.