Cleared Traditional

FOCUS EMG (K940050) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K940050 · Fasstech · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
415d
Days
Class 2
Risk

K940050 is an FDA 510(k) clearance for the FOCUS EMG. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Fasstech (Burlington, US). The FDA issued a Cleared decision on February 24, 1995 after a review of 415 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Fasstech devices

Submission Details

510(k) Number K940050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1994
Decision Date February 24, 1995
Days to Decision 415 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
267d slower than avg
Panel avg: 148d · This submission: 415d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.