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K Number
K010665
Device Name
TRANSAMERICA DIGITAL EMS
Manufacturer
TRANSAMERICA MEDICAL SYSTEMS
Date Cleared
2001-04-27

(52 days)

Product Code
IPF
Regulation Number
890.5850
Type
Special
Panel
PM
Reference & Predicate Devices
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).