Cleared Traditional

K040054 - BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLE

K040054 is an FDA 510(k) clearance for BACK IN ACTION COMPRESSION & SUPPORT WI..., manufactured by Theodore Barash. The device is a Class 1 General Hospital device with product code FQM cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K040054 · Theodore Barash · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
106d
Days
Class 1
Risk

K040054 is an FDA 510(k) clearance for the BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AN.... Classified as Bandage, Elastic (product code FQM), Class I - General Controls.

Submitted by Theodore Barash (Delray Beach, US). The FDA issued a Cleared decision on April 27, 2004 after a review of 106 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K040054

510(k) Number K040054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2004
Decision Date April 27, 2004
Days to Decision 106 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
23d faster than avg
Panel avg: 129d · This submission: 106d
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 K040054.
PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE
K040936 · Leda Co., Ltd. · May 2004
COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE
K013244 · Med Gen, Inc. · Dec 2001
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
K040054 · BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLE
Download PDF FDA Summary Theodore Barash