Cleared Traditional

WALK-A-CYCLE

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

About This 510(k) Submission

K820711 is an FDA 510(k) clearance for the WALK-A-CYCLE, a Walker, Mechanical (Class I — General Controls, product code ITJ), submitted by Walk-A-Cycle Division (Mchenry, US). The FDA issued a Cleared decision on April 8, 1982, 24 days after receiving the submission on March 15, 1982. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3825.

Submission Details

510(k) Number K820711 FDA.gov
FDA Decision Cleared 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 —

Device Classification

Product Code ITJ — Walker, Mechanical
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3825