HEELBO ER WRIST RESTRAINT— 510(k) K963372

Name: FDA 510(k) clearance K963372
Creator: U.S. Food and Drug Administration
Published: 1996-11-07

Substantially Equivalent

Heelbo, Inc.

FDA 510(k) clearance K963372 for HEELBO ER WRIST RESTRAINT, Substantially Equivalent on 1996-11-07. Applicant: Heelbo, Inc.. Device class: 1.

Clearance details

Applicant: Heelbo, Inc.
Product code: Code FMQ
Device class: Class 1
Regulation: 21 CFR 880.6760
Advisory panel: General Hospital
Date received: 1996-08-27
Decision date: 1996-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Libertyville, IL, US

Download summary PDF View on FDA.gov ↗

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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.