PATIENT RESTRAINTS— 510(k) K963906

Name: FDA 510(k) clearance K963906
Creator: U.S. Food and Drug Administration
Published: 1996-12-02

Substantially Equivalent

Safety Intl., Inc.

FDA 510(k) clearance K963906 for PATIENT RESTRAINTS, Substantially Equivalent on 1996-12-02. Applicant: Safety Intl., Inc.. Device class: 1.

Clearance details

Applicant: Safety Intl., Inc.
Product code: Code FMQ
Device class: Class 1
Regulation: 21 CFR 880.6760
Advisory panel: General Hospital
Date received: 1996-09-30
Decision date: 1996-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Casselberry, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FMQ

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K110377 — PROTECTIVE RESTRAINT2011-04-25
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K080448 — CENTURION PROTECTIVE RESTRAINT, SCR SERIES2008-08-28
K013239 — COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES2001-11-20
K010818 — INFANT LIMB HOLDER, MODELS 306080 & 3060812001-05-24

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.