Cleared Traditional

K970051 - MUSCLESENSE II CLINICAL ELECTROMYOGRAPH...

K970051 is an FDA 510(k) clearance for MUSCLESENSE II CLINICAL ELECTROMYOGRAPH..., manufactured by Smith and Nephew Donjoy, Inc.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K970051 · Smith and Nephew Donjoy, Inc. · Neurology device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K970051

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.

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 8
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K970051.
SONDREX P.A.L. SYSTEM
K010388 · Ohmeda Medical · Dec 2001
EAR MUFFINS
K012384 · Bio-Logic Systems Corp. · Oct 2001
EMG RETRAINER
K972487 · Chattanooga Group, Inc. · Sep 1997
J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS
K945826 · Medical Device Inspection Co., Inc. · Aug 1995