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K Number
K200354
Device Name
Electronic stimulator
Manufacturer
Shenzhen Dongjilian Electronics Co.,Ltd.
Date Cleared
2020-06-29

(137 days)

Product Code
NUH
Regulation Number
882.5890
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, lower extremities (leg) and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.

Device Description

Not Found

AI/ML Overview

This document is an FDA 510(k) clearance letter for an Electronic stimulator and does not contain information about the acceptance criteria, study details, or performance data of the device.

Therefore, I cannot provide the requested information.

§ 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).