SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL WHEELCHAIRS— 510(k) K020100

Substantially Equivalent

Regulatory Insight, Inc.

FDA 510(k) clearance K020100 for SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL WHEELCHAIRS, Substantially Equivalent on 2002-03-08. Applicant: Regulatory Insight, Inc..

Clearance details

Applicant: Regulatory Insight, Inc.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2002-01-11
Decision date: 2002-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, CO, US

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Adverse events under product code IOR

product code IOR

Death: 10
Injury: 232
Other: 2
Total: 244

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.