Cleared Traditional

COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES

K013239 · Med Gen, Inc. · General Hospital

Nov 2001

Decision

53d

Days

Class 1

Risk

About This 510(k) Submission

K013239 is an FDA 510(k) clearance for the COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES, a Restraint, Protective (Class I — General Controls, product code FMQ), submitted by Med Gen, Inc. (Boca Raton, US). The FDA issued a Cleared decision on November 20, 2001, 53 days after receiving the submission on September 28, 2001. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6760.

Submission Details

510(k) Number	K013239 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 2001
Decision Date	November 20, 2001
Days to Decision	53 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF