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K Number
K960489
Device Name
ULTRA IV
Manufacturer
EXCEL TECH. LTD.
Date Cleared
1996-03-27

(54 days)

Product Code
IPF,GZJ,IMG,IMI,LIH
Regulation Number
890.5850
Type
Traditional
Panel
Physical Medicine
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).