ACU-STIM TENS, AP-101082T

• K Number: K973980
• Device Name: ACU-STIM TENS, AP-101082T
• Manufacturer: APEX MEDICAL CORP.
• Date Cleared: 1998-07-29 ( 282 days)
• Product Code: GZJ
• Regulation Number: 882.5890
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

INDICATIONS: Transcutaneous Electrical Nerve Stimulator (TENS) devices are used for the symptomatic relief and management of chronic (long-term) intractable pain and as adjunctive treatment in the management of post surgical and post traumatic acute pain problems.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for two TENS devices: Multi-Stim TENS (AP-101081T) and Acu-Stim TENS (AP-101082T). This document does not contain information about acceptance criteria or a study proving device performance against such criteria.

The letter explicitly states that the devices are deemed "substantially equivalent" to legally marketed predicate devices. This means that the FDA reviewed documentation demonstrating that the new devices have the same intended use, technological characteristics, and safety and effectiveness as the predicate devices.

Therefore, I cannot provide the requested information based on the given text.

To be clear:

• No acceptance criteria are mentioned.
• No study proving device performance against acceptance criteria is described.
• No information on sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies is present.
• No human-in-the-loop performance or standalone algorithm performance is discussed.

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).