Cleared Traditional

DYNA T-2000 PHYSICAL THERAPY SYSTEM (K955808) - FDA 510(k) Clearance

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

K955808 · Thermia, Inc. · Physical Medicine device
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Nov 1997
Decision
682d
Days
Class 2
Risk

K955808 is an FDA 510(k) clearance for the DYNA T-2000 PHYSICAL THERAPY SYSTEM. Classified as Cabinet, Moist Steam (product code IMB), Class II - Special Controls.

Submitted by Thermia, Inc. (Edina, US). The FDA issued a Cleared decision on November 3, 1997 after a review of 682 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5250 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Thermia, Inc. devices

Submission Details

510(k) Number K955808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1995
Decision Date November 03, 1997
Days to Decision 682 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
567d slower than avg
Panel avg: 115d · This submission: 682d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IMB Cabinet, Moist Steam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5250
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.