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K Number
K020032
Device Name
APEX MEDICAL MINI TENS
Manufacturer
APEX MEDICAL CORP.
Date Cleared
2002-01-31

(27 days)

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

Mini TENS is intended to be used in symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details (sample size, data provenance, ground truth, experts, adjudication), or comparative effectiveness studies. The document is a 510(k) clearance letter for the Apex Medical Mini TENS device, indicating its substantial equivalence to a predicate device for symptomatic relief of chronic intractable pain, post-traumatic, and post-surgical pain. It does not contain the kind of detailed study results or performance metrics you are asking for.

§ 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).