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K Number
K961261
Device Name
DYNATRON 525
Manufacturer
DYNATRONICS CORP.
Date Cleared
1996-09-05

(156 days)

Product Code
LIH
Regulation Number
882.5890
Type
Traditional
Panel
Neurology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).