Cleared Traditional

K912595 - AXIOM ELECTROMYOGRAPH

K912595 is an FDA 510(k) clearance for AXIOM ELECTROMYOGRAPH, manufactured by The Computerist, Inc.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K912595 · The Computerist, Inc. · Neurology device
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Sep 1991
Decision
88d
Days
Class 2
Risk

K912595 is an FDA 510(k) clearance for the AXIOM ELECTROMYOGRAPH. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by The Computerist, Inc. (Chelmsford, US). The FDA issued a Cleared decision on September 6, 1991 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - 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: 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 The Computerist, Inc. devices

FDA 510(k) Submission Details - K912595

510(k) Number K912595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1991
Decision Date September 06, 1991
Days to Decision 88 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 148d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCC Device Classification - Class 2, Special Controls

Product Code HCC Device, Biofeedback
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
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 - HCC Device, Biofeedback

All 57
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K912595.
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