RESI-WALKER— 510(k) K823105

Substantially Equivalent

Orthion Corp.

FDA 510(k) clearance K823105 for RESI-WALKER, Substantially Equivalent on 1982-11-05. Applicant: Orthion Corp..

Clearance details

Applicant: Orthion Corp.
Product code: Code ITJ
Advisory panel: Physical Medicine
Date received: 1982-10-20
Decision date: 1982-11-05
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.