Cleared Special

K091317 - LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK

K091317 is an FDA 510(k) clearance for LUMBOFIX CONDUCTIVE GARMENT, manufactured by Bio-Medical Research, Ltd.. The device is a Class 2 Neurology device with product code GZJ cleared through the Special 510(k) pathway after a 52-day FDA review.

K091317 · Bio-Medical Research, Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
52d
Days
Class 2
Risk

K091317 is an FDA 510(k) clearance for the LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Bio-Medical Research, Ltd. (Galway, IE). The FDA issued a Cleared decision on June 25, 2009 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K091317

510(k) Number K091317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2009
Decision Date June 25, 2009
Days to Decision 52 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 149d · This submission: 52d
Pathway characteristics
Modification to existing cleared device.

GZJ Device Classification - Class 2, Special Controls

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 597
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K091317.
NEUROCALM MODEL 1 AND 2
K090866 · Neuromed Devices, Inc. · Oct 2009
NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS
K083250 · Aa Neuromed Corp. · Aug 2009
MANTRA COMBO, MODEL MECS 320
K091236 · Mantra Intl. (Hk) , Ltd. · Jul 2009
EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR
K090922 · Empi · Jun 2009
FLEX-TENS
K090717 · Emsi · May 2009
LASER TOUCHONE
K083822 · Laser Health Technologies, LLC · May 2009
K091317 · LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK
Download PDF FDA Summary Bio-Medical Research,…