COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE— 510(k) K013244

Name: FDA 510(k) clearance K013244
Creator: U.S. Food and Drug Administration
Published: 2001-12-07

Substantially Equivalent

Med Gen, Inc.

FDA 510(k) clearance K013244 for COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE, Substantially Equivalent on 2001-12-07. Applicant: Med Gen, Inc.. Device class: 1.

Clearance details

Applicant: Med Gen, Inc.
Product code: Code FQM
Device class: Class 1
Regulation: 21 CFR 880.5075
Advisory panel: General Hospital
Date received: 2001-09-28
Decision date: 2001-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FQM

view all

K040936 — PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE2004-05-03
K040054 — BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLE2004-04-27
K952738 — SKIN SAVER SYSTEMS1995-09-29
K872868 — ASPEN ESMARK BANDAGE1987-07-31
K840107 — TUBE-BANDAGE FOR HUMAN DIGITS 2001984-04-25

More clearances from Med Gen, Inc.

view all

K013239 — COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES2001-11-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.