Cleared Traditional

K970051 - MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE (FDA 510(k) Clearance)

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

K970051 · Smith and Nephew Donjoy, Inc. · Neurology device
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Jul 1997
Decision
184d
Days
Class 2
Risk

K970051 is an FDA 510(k) clearance for the MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Smith and Nephew Donjoy, Inc. (Carsbad, US). The FDA issued a Cleared decision on July 10, 1997 after a review of 184 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 Smith and Nephew Donjoy, Inc. devices

Submission Details

510(k) Number K970051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1997
Decision Date July 10, 1997
Days to Decision 184 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
36d slower than avg
Panel avg: 148d · This submission: 184d
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.