Cleared Traditional

K944543 - BIOFLEX GARMENTS, ASSORTED MODELS

K944543 is an FDA 510(k) clearance for BIOFLEX GARMENTS, manufactured by Bioflex, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 307-day FDA review.

K944543 · Bioflex, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
307d
Days
Class 2
Risk

K944543 is an FDA 510(k) clearance for the BIOFLEX GARMENTS, ASSORTED MODELS. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Bioflex, Inc. (Columbus, US). The FDA issued a Cleared decision on July 19, 1995 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Bioflex, Inc. devices

FDA 510(k) Submission Details - K944543

510(k) Number K944543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1994
Decision Date July 19, 1995
Days to Decision 307 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
159d slower than avg
Panel avg: 148d · This submission: 307d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

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 315
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K944543.
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