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K Number
K052711
Device Name
EMJOI TENS DEVICE
Manufacturer
EMJOI, INC.
Date Cleared
2006-06-23

(267 days)

Product Code
GZJ
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

The Emjoi TENS Device is intended for symptomatic relief of chronic intractable pain, posttraumatic and post-surgical pain.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to answer your request. The document is a 510(k) clearance letter from the FDA for a TENS device, but it does not describe any specific studies, acceptance criteria, or performance data for that device. It focuses on the regulatory aspect of market clearance based on substantial equivalence.

§ 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).