FULL BODY RESTRAINT SYSTEM— 510(k) K972046

Substantially Equivalent

Gillen Industries

FDA 510(k) clearance K972046 for FULL BODY RESTRAINT SYSTEM, Substantially Equivalent on 1997-08-15. Applicant: Gillen Industries.

Clearance details

Applicant: Gillen Industries
Product code: Code FMQ
Advisory panel: General Hospital
Date received: 1997-06-02
Decision date: 1997-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Providence, RI, 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.