Cleared Traditional

K902803 - A PHYSIOTHERAPY APPARATUS

K902803 is an FDA 510(k) clearance for A PHYSIOTHERAPY APPARATUS, manufactured by Grace River Ent., Inc.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K902803 · Grace River Ent., Inc. · Physical Medicine device
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Feb 1991
Decision
224d
Days
Class 2
Risk

K902803 is an FDA 510(k) clearance for the A PHYSIOTHERAPY APPARATUS. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Grace River Ent., Inc. (New York, US). The FDA issued a Cleared decision on February 6, 1991 after a review of 224 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5500 - 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 Grace River Ent., Inc. devices

FDA 510(k) Submission Details - K902803

510(k) Number K902803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1990
Decision Date February 06, 1991
Days to Decision 224 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
109d slower than avg
Panel avg: 115d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILY Device Classification - Class 2, Special Controls

Product Code ILY Lamp, Infrared, Therapeutic Heating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
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.