APEX MEDICAL DIGITAL TENS TS1211, TS1212

• K Number: K021755
• Device Name: APEX MEDICAL DIGITAL TENS TS1211, TS1212
• Manufacturer: APEX MEDICAL CORP.
• Date Cleared: 2002-06-12 ( 14 days)
• Product Code: GZJ
• Regulation Number: 882.5890
• Type: Special
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

Apex Medical Digital 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

This document is a 510(k) clearance letter from the FDA for a Transcutaneous Electrical Nerve Stimulator (TENS) device. It confirms that the device, Apex Medical Digital TENS Models TS-1211 and TS-1212, is substantially equivalent to legally marketed predicate devices.

The letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any other details typically found in a clinical or performance study report. The primary purpose of a 510(k) clearance letter is to state that the device is substantially equivalent to a predicate device, not to detail the results of its performance testing.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study that proves the device meets them based on the provided text.

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).