PATIENT RESTRAINT— 510(k) K760618

Substantially Equivalent

Encompass Group, LLC

FDA 510(k) clearance K760618 for PATIENT RESTRAINT, Substantially Equivalent on 1976-11-24. Applicant: Encompass Group, LLC.

Clearance details

Applicant: Encompass Group, LLC
Product code: Code FMQ
Advisory panel: General Hospital
Date received: 1976-09-13
Decision date: 1976-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, 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.