Musclesense Electromyography Device

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K951350 ↗

FDA Product Code

HCC

Device Class

Class II

Regulation

21 CFR Part 882.5050

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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• Musclesense II Clinical Electromyography Device

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See all devices from Smith and Nephew Donjoy, Inc. →

• What clinical specialties is the Musclesense Electromyography Device primarily intended for use in?

  The Musclesense Electromyography Device is specifically designed for use in neurology specialties. It measures and displays electrical activity in skeletal muscles to evaluate muscle function and nerve integrity, making it a valuable tool for diagnosing and monitoring neurological conditions.

• Is the Musclesense Electromyography Device reusable or single-use, and how should it be maintained?

  The Musclesense Electromyography Device is supplied as a reusable clinical instrument. Since it is not intended for single-use, proper cleaning, sterilization, and maintenance procedures must be followed as per manufacturer guidelines to ensure accuracy, reliability, and infection control in clinical settings.

• What regulatory pathway was used for FDA clearance of the Musclesense Electromyography Device, and what classification does it hold?

  The Musclesense Electromyography Device received FDA 510(k) clearance under the Traditional pathway and is classified as a Class II medical device. It is regulated under the FDA’s special controls for biofeedback devices (regulation number 882.5050), ensuring compliance with performance standards for electromyography assessments.

• How is the Musclesense Electromyography Device intended to be used in clinical practice?

  The device is intended for electromyography (EMG) assessments, which involve measuring and analyzing the electrical activity generated by skeletal muscles. This helps clinicians evaluate muscle function, nerve integrity, and diagnose conditions such as neuromuscular disorders, nerve compression, or muscle dysfunction in neurology settings.