LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401

• K Number: K040512
• Device Name: LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401
• Manufacturer: WELL-LIFE HEALTHCARE, INC.
• Date Cleared: 2004-05-27 ( 90 days)
• Product Code: GZJ
• Regulation Number: 882.5890
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

• The model WL-2402, WL-2403 TENS are intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
• The model WL-2401 TENS is indicated for use in the relief of nausea and vomiting due to motion sickness, and for the relief of mild to moderate nausea and vomiting associated with pregnancy.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for Transcutaneous Electrical Nerve Stimulators (TENS) and does not contain information about acceptance criteria, device performance, study design, or ground truth establishment. It primarily discusses the regulatory classification and marketing authorization for the devices based on substantial equivalence to predicate devices.

Therefore, I cannot provide the requested information about acceptance criteria, study details, and ground truth from 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).