Cleared Traditional

K894152 - MEDITHERM

K894152 is an FDA 510(k) clearance for MEDITHERM, manufactured by Medical Equipment Designs, Inc.. The device is a Class 2 Physical Medicine device with product code IMI cleared through the Traditional 510(k) pathway after a 362-day FDA review.

K894152 · Medical Equipment Designs, Inc. · Physical Medicine device
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Jun 1990
Decision
362d
Days
Class 2
Risk

K894152 is an FDA 510(k) clearance for the MEDITHERM. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Medical Equipment Designs, Inc. (Jefferson City, US). The FDA issued a Cleared decision on June 11, 1990 after a review of 362 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Medical Equipment Designs, Inc. devices

FDA 510(k) Submission Details - K894152

510(k) Number K894152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1989
Decision Date June 11, 1990
Days to Decision 362 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
247d slower than avg
Panel avg: 115d · This submission: 362d
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
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K894152.
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K880901 · Mettler Electronics Corp. · Mar 1988
MODIFIED SONICATOR 720, MODEL ME720
K880602 · Mettler Electronics Corp. · Feb 1988