THE INCH QUILTED LIMB HOLDER WITH QUICK RELEASE SNAP CLOSURE— 510(k) K962831

Substantially Equivalent

Heelbo, Inc.

FDA 510(k) clearance K962831 for THE INCH QUILTED LIMB HOLDER WITH QUICK RELEASE SNAP CLOSURE, Substantially Equivalent on 1996-10-18. Applicant: Heelbo, Inc..

Clearance details

Applicant: Heelbo, Inc.
Product code: Code FMQ
Advisory panel: General Hospital
Date received: 1996-07-22
Decision date: 1996-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Libertyville, IL, US

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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.