Cleared Traditional

K013239 - COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES

K013239 is an FDA 510(k) clearance for COMFORTCARE COMPRESSION SUPPORT WITH MA..., manufactured by Med Gen, Inc.. The device is a Class 1 General Hospital device with product code FMQ cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K013239 · Med Gen, Inc. · General Hospital
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Nov 2001
Decision
53d
Days
Class 1
Risk

K013239 is an FDA 510(k) clearance for the COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES. Classified as Restraint, Protective (product code FMQ), Class I - General Controls.

Submitted by Med Gen, Inc. (Boca Raton, US). The FDA issued a Cleared decision on November 20, 2001 after a review of 53 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6760 - 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.

View all Med Gen, Inc. devices

FDA 510(k) Submission Details - K013239

510(k) Number K013239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 129d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

FMQ Device Classification - Class 1, General Controls

Product Code FMQ Restraint, Protective
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6760
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 - FMQ Restraint, Protective

All 122
Devices cleared under the same product code (FMQ) and FDA review panel - the closest regulatory comparables to K013239.
PROTECTIVE RESTRAINT
K110377 · Medi-Tech Intl. Corp. · Apr 2011
CENTURION PROTECTIVE RESTRAINT, SCR SERIES
K080448 · Tri-State Hospital Supply Corp. · Aug 2008
INFANT LIMB HOLDER, MODELS 306080 & 306081
K010818 · Skil-Care Corp. · May 2001
CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025
K010644 · Skil-Care Corp. · May 2001
BIOTHANE PATIENT RESTRAINT
K991591 · Bioplastics · Jul 1999
VAGABOND SOFT RESTRAINT SYSTEM
K982178 · Emergent Innovations, Ltd. · Jan 1999