Cleared Traditional

K913026 - TTU-100THERMAL THERAPY UNIT (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K913026 · Danninger Medical Technology, Inc. · Physical Medicine device
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Dec 1991
Decision
157d
Days
Class 2
Risk

K913026 is an FDA 510(k) clearance for the TTU-100THERMAL THERAPY UNIT. Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Danninger Medical Technology, Inc. (Concord, US). The FDA issued a Cleared decision on December 13, 1991 after a review of 157 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5720 - 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 Danninger Medical Technology, Inc. devices

Submission Details

510(k) Number K913026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1991
Decision Date December 13, 1991
Days to Decision 157 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 115d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ILO Pack, Hot Or Cold, Water Circulating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5720
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.