PROTECTIVE RESTRAINT (PROTECTIVE MITT)— 510(k) K963422

Substantially Equivalent

Kenad SG Medical, Inc.

FDA 510(k) clearance K963422 for PROTECTIVE RESTRAINT (PROTECTIVE MITT), Substantially Equivalent on 1996-11-22. Applicant: Kenad SG Medical, Inc..

Clearance details

Applicant: Kenad SG Medical, Inc.
Product code: Code FMQ
Advisory panel: General Hospital
Date received: 1996-08-30
Decision date: 1996-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

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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.