Cleared Traditional

K861864 - MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT

K861864 is the FDA 510(k) clearance for MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT by I-Rep, Inc.. It is a Class 2 Physical Medicine device (product code IMJ) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K861864 · I-Rep, Inc. · Physical Medicine device
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Jul 1986
Decision
60d
Days
Class 2
Risk

K861864 is an FDA 510(k) clearance for the MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT. Classified as Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (product code IMJ), Class II - Special Controls.

Submitted by I-Rep, Inc. (Lake Elsinore, US). The FDA issued a Cleared decision on July 14, 1986 after a review of 60 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all I-Rep, Inc. devices

Submission Details

510(k) Number K861864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1986
Decision Date July 14, 1986
Days to Decision 60 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
55d faster than avg
Panel avg: 115d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IMJ Diathermy, Shortwave, For Use In 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.

Regulatory Peers - IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

All 15
Devices cleared under the same product code (IMJ) and FDA review panel - the closest regulatory comparables to K861864.
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