Cleared Traditional

K831889 - SURGEON'S CHOICE CRUTCH HANDLE

K831889 is the FDA 510(k) clearance for SURGEON'S CHOICE CRUTCH HANDLE by W.K. Wheeler, Inc.. It is a Class 1 Physical Medicine device (product code INP) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K831889 · W.K. Wheeler, Inc. · Physical Medicine device
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Jul 1983
Decision
23d
Days
Class 1
Risk

K831889 is an FDA 510(k) clearance for the SURGEON'S CHOICE CRUTCH HANDLE. Classified as Tips And Pads, Cane, Crutch And Walker (product code INP), Class I - General Controls.

Submitted by W.K. Wheeler, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 7, 1983 after a review of 23 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 W.K. Wheeler, Inc. devices

Submission Details

510(k) Number K831889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1983
Decision Date July 07, 1983
Days to Decision 23 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
92d faster than avg
Panel avg: 115d · This submission: 23d
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.

Regulatory Peers - INP Tips And Pads, Cane, Crutch And Walker

Devices cleared under the same product code (INP) and FDA review panel - the closest regulatory comparables to K831889.
PERSONAL KNEE CRUTCH PAD
K831149 · Tecnol New Jersey Wound Care, Inc. · May 1983
CRUTCH & WALKER PADS
K811493 · Fred Sammons, Inc. · Jun 1981
CONPHAR CRUTCH TIPS
K803136 · Conphar, Inc. · Jan 1981
CONPHAR CRUTCH GRIPS
K803140 · Conphar, Inc. · Jan 1981
CONPHAR CRUTCH PADS
K803144 · Conphar, Inc. · Jan 1981