WALK-A-CYCLE— 510(k) K820711

Substantially Equivalent

Walk-A-Cycle Division

FDA 510(k) clearance K820711 for WALK-A-CYCLE, Substantially Equivalent on 1982-04-08. Applicant: Walk-A-Cycle Division.

Clearance details

Applicant: Walk-A-Cycle Division
Product code: Code ITJ
Advisory panel: Physical Medicine
Date received: 1982-03-15
Decision date: 1982-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code ITJ

product code ITJ

Death: 8
Injury: 571
Other: 2
Total: 581

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.