PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20

• K Number: K960761
• Device Name: PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20
• Manufacturer: THE PROMETHEUS GROUP
• Date Cleared: 1996-08-07 ( 163 days)
• Product Code: HCC
• Regulation Number: 882.5050

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 882.5050 Biofeedback device.

(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.

Summary

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