Cleared Traditional

IPUP 200 (INTELLIGENT PRESSURE ULCER PREVENTION) (K063175) - FDA 510(k) Clearance

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

K063175 · Medical Technology Systems, Inc. · Physical Medicine device
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Mar 2008
Decision
512d
Days
Class 2
Risk

K063175 is an FDA 510(k) clearance for the IPUP 200 (INTELLIGENT PRESSURE ULCER PREVENTION). Classified as Cushion, Flotation, Therapeutic (product code MOC), Class II - Special Controls.

Submitted by Medical Technology Systems, Inc. (Chicago, US). The FDA issued a Cleared decision on March 14, 2008 after a review of 512 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5170 - 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 Medical Technology Systems, Inc. devices

Submission Details

510(k) Number K063175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2006
Decision Date March 14, 2008
Days to Decision 512 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
397d slower than avg
Panel avg: 115d · This submission: 512d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MOC Cushion, Flotation, Therapeutic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5170
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.