HEELBO QUILTED TORSO RESTRAINT— 510(k) K963108

Substantially Equivalent

Hollister, Inc.

FDA 510(k) clearance K963108 for HEELBO QUILTED TORSO RESTRAINT, Substantially Equivalent on 1996-10-09. Applicant: Hollister, Inc..

Clearance details

Applicant: Hollister, Inc.
Product code: Code FMQ
Advisory panel: General Hospital
Date received: 1996-08-12
Decision date: 1996-10-09
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.