Cleared Traditional

K871633 - TRU-SOUND ULTRASOUND THERAPY UNIT

K871633 is the FDA 510(k) clearance for TRU-SOUND ULTRASOUND THERAPY UNIT by Tru-Trac Therapy Products, Inc.. It is a Class 2 Physical Medicine device (product code IMJ) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K871633 · Tru-Trac Therapy Products, Inc. · Physical Medicine device
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May 1987
Decision
31d
Days
Class 2
Risk

K871633 is an FDA 510(k) clearance for the TRU-SOUND ULTRASOUND THERAPY UNIT. Classified as Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (product code IMJ), Class II - Special Controls.

Submitted by Tru-Trac Therapy Products, Inc. (Temecula, US). The FDA issued a Cleared decision on May 28, 1987 after a review of 31 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 Tru-Trac Therapy Products, Inc. devices

Submission Details

510(k) Number K871633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1987
Decision Date May 28, 1987
Days to Decision 31 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
84d faster than avg
Panel avg: 115d · This submission: 31d
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
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