Cleared Traditional

K013244 - COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE

K013244 is an FDA 510(k) clearance for COMFORTCARE COMPRESSION SUPPORT WITIH M..., manufactured by Med Gen, Inc.. The device is a Class 1 General Hospital device with product code FQM cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K013244 · Med Gen, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
70d
Days
Class 1
Risk

K013244 is an FDA 510(k) clearance for the COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFOR.... Classified as Bandage, Elastic (product code FQM), Class I - General Controls.

Submitted by Med Gen, Inc. (Boca Raton, US). The FDA issued a Cleared decision on December 7, 2001 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5075 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K013244

510(k) Number K013244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 129d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

FQM Device Classification - Class 1, General Controls

Product Code FQM Bandage, Elastic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5075
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FQM Bandage, Elastic

All 35
Devices cleared under the same product code (FQM) and FDA review panel - the closest regulatory comparables to K013244.
PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE
K040936 · Leda Co., Ltd. · May 2004
BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLE
K040054 · Theodore Barash · Apr 2004
SKIN SAVER SYSTEMS
K952738 · Skin Saver Systems, Inc. · Sep 1995
ASPEN ESMARK BANDAGE
K872868 · Aspen Laboratories, Inc. · Jul 1987
TUBE-BANDAGE FOR HUMAN DIGITS 200
K840107 · Zens Health Care Products · Apr 1984
MEDICALEX
K831728 · Medicalex · Jan 1984
K013244 · COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE
Download PDF FDA Summary Med Gen, Inc.