Cleared Traditional

COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE

K013244 · Med Gen, Inc. · General Hospital

Dec 2001

Decision

70d

Days

Class 1

Risk

About This 510(k) Submission

K013244 is an FDA 510(k) clearance for the COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE, a Bandage, Elastic (Class I — General Controls, product code FQM), submitted by Med Gen, Inc. (Boca Raton, US). The FDA issued a Cleared decision on December 7, 2001, 70 days after receiving the submission on September 28, 2001. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5075.

Submission Details

510(k) Number	K013244 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 2001
Decision Date	December 07, 2001
Days to Decision	70 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF