APEX MEDICAL LCD TENS-VII

• K Number: K012643
• Device Name: APEX MEDICAL LCD TENS-VII
• Manufacturer: APEX MEDICAL CORP.
• Date Cleared: 2001-10-29 ( 77 days)
• Product Code: GZJ
• Regulation Number: 882.5890
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

LCD TENS-VII 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

The provided document describes the FDA's 510(k) clearance for the "Apex Medical LCD TENS-VII" device. It is a regulatory letter stating that the device is substantially equivalent to legally marketed predicate devices for the specified indications for use.

This document does NOT contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The letter focuses on the regulatory clearance process and confirms that the device can be legally marketed based on its substantial equivalence to existing devices. It does not include the technical details of any performance studies.

Therefore, I cannot provide the requested information from the given text as it is not present in the document.

Regulation Number and Section

§ 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).