Cleared Traditional

K881211 - TRU-TECH 310 ULTRASOUND THERAPY UNIT #310

K881211 is the FDA 510(k) clearance for TRU-TECH 310 ULTRASOUND THERAPY UNIT #310 by Tru-Trac Therapy Products, Inc.. It is a Class 2 Physical Medicine device (product code IMI) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K881211 · Tru-Trac Therapy Products, Inc. · Physical Medicine device
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May 1988
Decision
51d
Days
Class 2
Risk

K881211 is an FDA 510(k) clearance for the TRU-TECH 310 ULTRASOUND THERAPY UNIT #310. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Tru-Trac Therapy Products, Inc. (Temecula, US). The FDA issued a Cleared decision on May 11, 1988 after a review of 51 days - a notably fast clearance 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: 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 K881211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1988
Decision Date May 11, 1988
Days to Decision 51 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
64d faster than avg
Panel avg: 115d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

Regulatory Peers - IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

All 32
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K881211.
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RICH-MAR MODEL V ULTRASOUND
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SONICATOR 720 (MODEL ME720)
K883228 · Mettler Electronics Corp. · Aug 1988
SONICATOR 710 (MODEL ME710)
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MODIFIED SONICATOR 720, MODEL ME720
K880602 · Mettler Electronics Corp. · Feb 1988
SONICATOR 720 (MODEL ME720)
K873812 · Mettler Electronics Corp. · Dec 1987