PROTECTIVE RESTRAINT— 510(k) K110377

Substantially Equivalent

Medi-Tech Intl. Corp.

FDA 510(k) clearance K110377 for PROTECTIVE RESTRAINT, Substantially Equivalent on 2011-04-25. Applicant: Medi-Tech Intl. Corp..

Clearance details

Applicant: Medi-Tech Intl. Corp.
Product code: Code FMQ
Advisory panel: General Hospital
Date received: 2011-02-09
Decision date: 2011-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brooklyn, NY, 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.