TENS and EMS Stimulation (OTC)

• K Number: K230164
• Device Name: TENS and EMS Stimulation (OTC)
• Manufacturer: Changsha Yuwen Medical Equipment Co., Ltd
• Date Cleared: 2023-04-10 ( 80 days)
• Product Code: NUH , NGX
• Regulation Number: 882.5890
• Type: Traditional
• Panel: Physical Medicine
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

TENS: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: To be used for stimulation healthy muscles in order to improve or facilitate muscle performance.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a TENS and EMS Stimulation device, confirming its substantial equivalence to predicate devices and outlining regulatory requirements. It does not contain details about specific performance studies, sample sizes, ground truth establishment, or expert reviews.

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).