TENS and EMS Stimulation (OTC)

• K Number: K230163
• Device Name: TENS and EMS Stimulation (OTC)
• Manufacturer: Changsha Yuwen Medical Equipment Co., Ltd
• Date Cleared: 2023-03-20 ( 59 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 the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for a TENS and EMS Stimulation device, detailing its regulatory classification and indications for use. It does not include specifics on performance metrics, study design, or data analysis as requested in your prompt.

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).