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

Name: FDA 510(k) clearance K013239
Creator: U.S. Food and Drug Administration
Published: 2001-11-20

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.. Device class: 1.

Clearance details

Applicant: Med Gen, Inc.
Product code: Code FMQ
Device class: Class 1
Regulation: 21 CFR 880.6760
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

Download summary PDF View on FDA.gov ↗

Recent devices under product code FMQ

view all

K110377 — PROTECTIVE RESTRAINT2011-04-25
K081264 — STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-0022009-02-13
K080448 — CENTURION PROTECTIVE RESTRAINT, SCR SERIES2008-08-28
K010818 — INFANT LIMB HOLDER, MODELS 306080 & 3060812001-05-24
K010644 — CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 9120252001-05-18

More clearances from Med Gen, Inc.

view all

K013244 — COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE2001-12-07

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.