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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
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 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).