Cleared Traditional

K970533 - MODEL 1100 COLD THERAPY DEVICE

K970533 is the FDA 510(k) clearance for MODEL 1100 COLD THERAPY DEVICE by Smith & Nephew, Inc.. It is a Class 2 Physical Medicine device (product code ILO) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K970533 · Smith & Nephew, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
62d
Days
Class 2
Risk

K970533 is an FDA 510(k) clearance for the MODEL 1100 COLD THERAPY DEVICE. Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Carlsbad, US). The FDA issued a Cleared decision on April 15, 1997 after a review of 62 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K970533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1997
Decision Date April 15, 1997
Days to Decision 62 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 115d · This submission: 62d
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.

Regulatory Peers - ILO Pack, Hot Or Cold, Water Circulating

All 17
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