(84 days)
TENS: The device is designed 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: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.
The device of the model TU3424-F is a portable, battery powered (lithium battery 3.7V DC) multifunction device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (EMS) qualities in one device, it can be used for arm, shoulder, neck, back, waist, abdomen, and leg. 4 channels that effectively transfer your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. There are 24 modes of operations. The electrode pads are cleared by FDA, and 510(k) number is K092546 for the electrode pads. They are used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current is first transmitted via the lead wire or snap button then transmitted to the conductive gel which is adhered to patient skin. The electrode pads are composed of a cover, connector lead wire or snap button, conductive carbon film, conductive hydrogel, and an electrode carrier liner. It is non-sterile and intended for single adult patient (age ≥ 18) multiple application use. Its output waveform is provided 24 programs and 20 adjustable intensity levels. The LCD screen shows the information of program, level, operating time and channel.
This is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) & Powered Muscle Stimulator (EMS) device, indicating that its substantial equivalence to a predicate device was established based on non-clinical performance data and adherence to recognized standards. A clinical study proving acceptance criteria is not applicable for this type of submission, as the FDA has determined that clinical data is not required to demonstrate substantial equivalence for these devices.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to a legally marketed predicate device (K202866, Model: FM-B2403) by meeting recognized voluntary standards and confirming that performance differences do not raise new safety or effectiveness concerns.
| Acceptance Criteria (based on predicate equivalence and standards) | Reported Device Performance (New device: TU3424-F) |
|---|---|
| Regulatory Information: Aligns with predicate for regulation numbers (21 CFR 882.5890, 21 CFR 890.5850), classification (Class II), and product codes (NUH, NGX). | SE (Substantially Equivalent) |
| Intended Use: Identical indications for TENS and EMS. | SE (Substantially Equivalent) |
| Applied Parts of the Body: Identical areas for application. | SE (Substantially Equivalent) |
| Power Source: Built-in 3.7V lithium battery. | SE (Substantially Equivalent) |
| Method of Line Current Isolation: BF | SE (Substantially Equivalent) |
| Patient Leakage Current: Normal condition |
§ 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).