SIGMA MANUAL WHEELCHAIR— 510(k) K993963

Substantially Equivalent

Sigma Distribution & Supply, Inc.

FDA 510(k) clearance K993963 for SIGMA MANUAL WHEELCHAIR, Substantially Equivalent on 2000-01-13. Applicant: Sigma Distribution & Supply, Inc..

Clearance details

Applicant: Sigma Distribution & Supply, Inc.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 1999-11-22
Decision date: 2000-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendale, CA, 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.