WHEEL CHAIR ACCESSORY— 510(k) K963489

Substantially Equivalent

Smith and Nephew Donjoy, Inc.

FDA 510(k) clearance K963489 for WHEEL CHAIR ACCESSORY, Substantially Equivalent on 1996-11-12. Applicant: Smith and Nephew Donjoy, Inc..

Clearance details

Applicant: Smith and Nephew Donjoy, Inc.
Product code: Code FMQ
Advisory panel: General Hospital
Date received: 1996-09-03
Decision date: 1996-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vista, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMQ

product code FMQ

Death: 8
Total: 8

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.