Cleared Traditional

K770223 - HEAVY FOAM HEEL & ELBOW PROTECTORS (FDA 510(k) Clearance)

Class I Physical Medicine device.

K770223 · Robert R. Moore · Physical Medicine device
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Feb 1977
Decision
20d
Days
Class 1
Risk

K770223 is an FDA 510(k) clearance for the HEAVY FOAM HEEL & ELBOW PROTECTORS. Classified as Cover, Limb (product code IPM), Class I - General Controls.

Submitted by Robert R. Moore (Walker, US). The FDA issued a Cleared decision on February 23, 1977 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3025 - 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 Robert R. Moore devices

Submission Details

510(k) Number K770223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1977
Decision Date February 23, 1977
Days to Decision 20 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
95d faster than avg
Panel avg: 115d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IPM Cover, Limb
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3025
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.