PATIENT RESTRAINT— 510(k) K971948

Name: FDA 510(k) clearance K971948
Creator: U.S. Food and Drug Administration
Published: 1997-08-06

Substantially Equivalent

E.M. Adams Co., Inc.

FDA 510(k) clearance K971948 for PATIENT RESTRAINT, Substantially Equivalent on 1997-08-06. Applicant: E.M. Adams Co., Inc.. Device class: 1.

Clearance details

Applicant: E.M. Adams Co., Inc.
Product code: Code FMQ
Device class: Class 1
Regulation: 21 CFR 880.6760
Advisory panel: General Hospital
Date received: 1997-05-28
Decision date: 1997-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Pierce, FL, US

Download summary PDF View on FDA.gov ↗

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K971536 — RESTRAINTS (VESTS AND JACKETS)1997-07-01

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.