Cleared Traditional

K875381 - ULTRASOUND DIATHERMY UNIT ULTRASOUND HEATER

K875381 is an FDA 510(k) clearance for ULTRASOUND DIATHERMY UNIT ULTRASOUND HEATER, manufactured by Ford Laboratories, Inc.. The device is a Class 2 Physical Medicine device with product code IMI cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K875381 · Ford Laboratories, Inc. · Physical Medicine device
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May 1988
Decision
148d
Days
Class 2
Risk

K875381 is an FDA 510(k) clearance for the ULTRASOUND DIATHERMY UNIT ULTRASOUND HEATER. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Ford Laboratories, Inc. (Dublin, US). The FDA issued a Cleared decision on May 3, 1988 after a review of 148 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.

View all Ford Laboratories, Inc. devices

FDA 510(k) Submission Details - K875381

510(k) Number K875381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1987
Decision Date May 03, 1988
Days to Decision 148 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
33d slower than avg
Panel avg: 115d · This submission: 148d
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 64
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