Cleared Traditional

THE TUCKER-SACH FOOT AND TUCKER-SYME FT (K791331) - FDA 510(k) Clearance

Class I Physical Medicine device.

K791331 · Kiswood Manufacturing, Inc. · Physical Medicine device
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Aug 1979
Decision
16d
Days
Class 1
Risk

K791331 is an FDA 510(k) clearance for the THE TUCKER-SACH FOOT AND TUCKER-SYME FT. Classified as Component, External, Limb, Ankle/foot (product code ISH), Class I - General Controls.

Submitted by Kiswood Manufacturing, Inc. (Walker, US). The FDA issued a Cleared decision on August 3, 1979 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3420 - 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 Kiswood Manufacturing, Inc. devices

Submission Details

510(k) Number K791331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1979
Decision Date August 03, 1979
Days to Decision 16 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
99d faster than avg
Panel avg: 115d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ISH Component, External, Limb, Ankle/foot
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3420
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.