Cleared Traditional

K895635 - MYOSYSTEM 1000 ELECTROMYOGRAPH

K895635 is an FDA 510(k) clearance for MYOSYSTEM 1000 ELECTROMYOGRAPH, manufactured by Noraxon USA, Inc.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 212-day FDA review.

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

FDA 510(k) Submission Details - K895635

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.

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 K895635.
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K881416 · Thought Technology , Ltd. · Sep 1988