VEST RESTRAINT— 510(k) K771634

Substantially Equivalent

Medical Restraints, Inc.

FDA 510(k) clearance K771634 for VEST RESTRAINT, Substantially Equivalent on 1977-09-28. Applicant: Medical Restraints, Inc..

Clearance details

Applicant: Medical Restraints, Inc.
Product code: Code FMQ
Advisory panel: General Hospital
Date received: 1977-08-26
Decision date: 1977-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.