Cleared Traditional

K102614 - AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULD...

K102614 is the FDA 510(k) clearance for AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULD... by Bio-Medical Research, Ltd.. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K102614 · Bio-Medical Research, Ltd. · Neurology device
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Jun 2011
Decision
266d
Days
Class 2
Risk

K102614 is an FDA 510(k) clearance for the AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Bio-Medical Research, Ltd. (Galway, IE). The FDA issued a Cleared decision on June 3, 2011 after a review of 266 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bio-Medical Research, Ltd. devices

Submission Details

510(k) Number K102614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2010
Decision Date June 03, 2011
Days to Decision 266 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 148d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 142
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