Cleared Traditional

MYOSYSTEM 1000 ELECTROMYOGRAPH (K895635) - FDA 510(k) Clearance

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

K895635 · Noraxon USA, Inc. · Neurology device
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Apr 1990
Decision
212d
Days
Class 2
Risk

K895635 is an FDA 510(k) clearance for the MYOSYSTEM 1000 ELECTROMYOGRAPH. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Noraxon USA, Inc. (Scottsdale, US). The FDA issued a Cleared decision on April 19, 1990 after a review of 212 days - an extended review 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: 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 Noraxon USA, Inc. devices

Submission Details

510(k) Number K895635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1989
Decision Date April 19, 1990
Days to Decision 212 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 148d · This submission: 212d
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.