Cleared Traditional

K820711 - WALK-A-CYCLE

K820711 is an FDA 510(k) clearance for WALK-A-CYCLE, manufactured by Walk-A-Cycle Division. The device is a Class 1 Physical Medicine device with product code ITJ cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K820711 · Walk-A-Cycle Division · Physical Medicine device
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Apr 1982
Decision
24d
Days
Class 1
Risk

K820711 is an FDA 510(k) clearance for the WALK-A-CYCLE. Classified as Walker, Mechanical (product code ITJ), Class I - General Controls.

Submitted by Walk-A-Cycle Division (Mchenry, US). The FDA issued a Cleared decision on April 8, 1982 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3825 - 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.

FDA 510(k) Submission Details - K820711

510(k) Number K820711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1982
Decision Date April 08, 1982
Days to Decision 24 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 116d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

ITJ Device Classification - Class 1, General Controls

Product Code ITJ Walker, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3825
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 - ITJ Walker, Mechanical

All 12
Devices cleared under the same product code (ITJ) and FDA review panel - the closest regulatory comparables to K820711.
RESI-WALKER
K830848 · Lic-Orthion · Apr 1983
RESI-WALKER
K823105 · Orthion Corp. · Nov 1982
LIGHT WEIGHT ALUMINUM WALKER
K821404 · Manuco Manufacturing Co., Inc. · May 1982
WALKER/CRUTCH BAG
K811485 · Fred Sammons, Inc. · Jun 1981
WALKING AID
K790529 · Maddak, Inc. · Apr 1979
WALKING AID
K772049 · Guardian Products Co., Inc. · Nov 1977
K820711 · WALK-A-CYCLE
Download PDF Walk-A-Cycle Division