Cleared Traditional

K812752 - MICRO MED INT'L MICRO SOUND US-100

K812752 is an FDA 510(k) clearance for MICRO MED INT'L MICRO SOUND US-100, manufactured by N-Tron Electronics. The device is a Class 2 Physical Medicine device with product code IMI cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K812752 · N-Tron Electronics · Physical Medicine device
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Jan 1982
Decision
112d
Days
Class 2
Risk

K812752 is an FDA 510(k) clearance for the MICRO MED INT'L MICRO SOUND US-100. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by N-Tron Electronics (Mchenry, US). The FDA issued a Cleared decision on January 19, 1982 after a review of 112 days - within the typical 510(k) review window.

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: 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.

FDA 510(k) Submission Details - K812752

510(k) Number K812752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1981
Decision Date January 19, 1982
Days to Decision 112 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 116d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IMI Device Classification - Class 2, Special Controls

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 87
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K812752.
INTELECT 200 THERAPEUTIC ULTRASOUND
K841446 · Chattanooga Group, Inc. · May 1984
INTELECT 210 PORTABLE ULTRASOUND
K841447 · Chattanooga Group, Inc. · May 1984
INTELECT MODEL 200
K813593 · Chattanooga Group, Inc. · Feb 1982
DYNASOUND 801
K811159 · Dynawave, Corp. · May 1981
MODEL 118 PULSE MEGASON
K800632 · Birtcher Corp. · May 1980
ULTRASONIC THERAPY APPARATUS, 407
K781317 · General Theraphysical, Inc. · Oct 1978
K812752 · MICRO MED INT'L MICRO SOUND US-100
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