NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT,

• K Number: K120853
• Device Name: NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT,
• Manufacturer: BIONESS, INC.
• Date Cleared: 2012-04-20 ( 30 days)
• Product Code: GZI
• Regulation Number: 882.5810
• Type: Special
• Panel: Neurology
• Reference & Predicate Devices: N/A
• Predicate For: K122784

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).