COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES— 510(k) K013239

Substantially Equivalent

Med Gen, Inc.

FDA 510(k) clearance K013239 for COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES, Substantially Equivalent on 2001-11-20. Applicant: Med Gen, Inc..

Clearance details

Applicant: Med Gen, Inc.
Product code: Code FMQ
Advisory panel: General Hospital
Date received: 2001-09-28
Decision date: 2001-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, 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.