Cleared Traditional

K894152 - MEDITHERM

K894152 is the FDA 510(k) clearance for MEDITHERM by Medical Equipment Designs, Inc.. It is a Class 2 Physical Medicine device (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

Submission Details

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.

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 13
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K894152.
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