HANDMASTER

• K Number: K010837
• Device Name: HANDMASTER
• Manufacturer: NEUROMUSCLAR ELECTRICAL STIMULATION SYSTEMS, LTD.
• Date Cleared: 2001-06-15 ( 87 days)
• Product Code: GZI , IPF , IRO
• Regulation Number: 882.5810
• Type: Traditional
• Panel: Neurology
• Age Range: N/A
• Reference & Predicate Devices: N/A
• Predicate For: K012823 , K031900

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

§ 882.5810 External functional neuromuscular stimulator.

(a)
Identification. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.(b)
Classification. Class II (performance standards).