HEELBO WRAP AROUND VEST— 510(k) K963294

Substantially Equivalent

Heelbo, Inc.

FDA 510(k) clearance K963294 for HEELBO WRAP AROUND VEST, Substantially Equivalent on 1996-10-11. Applicant: Heelbo, Inc..

Clearance details

Applicant: Heelbo, Inc.
Product code: Code FMQ
Advisory panel: General Hospital
Date received: 1996-08-21
Decision date: 1996-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Libertyville, IL, 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.