Cleared Traditional

K831149 - PERSONAL KNEE CRUTCH PAD (FDA 510(k) Clearance)

Class I Physical Medicine device.

K831149 · Tecnol New Jersey Wound Care, Inc. · Physical Medicine device
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May 1983
Decision
25d
Days
Class 1
Risk

K831149 is an FDA 510(k) clearance for the PERSONAL KNEE CRUTCH PAD. Classified as Tips And Pads, Cane, Crutch And Walker (product code INP), Class I - General Controls.

Submitted by Tecnol New Jersey Wound Care, Inc. (Hammonton, US). The FDA issued a Cleared decision on May 3, 1983 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3790 - 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 Tecnol New Jersey Wound Care, Inc. devices

Submission Details

510(k) Number K831149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1983
Decision Date May 03, 1983
Days to Decision 25 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
90d faster than avg
Panel avg: 115d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code INP Tips And Pads, Cane, Crutch And Walker
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3790
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.