(361 days)
The Mini-TENS including a series of TENS models (WL-2401, WL-2402, WL-2403, and WL-2302) is intended for symptomatic relief of chronic intractable pain.
The Mini-TENS series, including WL-2401, WL-2402, WL-2403, and WL-2302 are transcutaneous electrical nerve stimulator used for pain relief by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the situation of patient.
Mini-TENS series, models WL-2401, WL-2402, WL-2403, and WL-2302, consist mainly of two parts: the stimulus generator, electrode. The stimulus generator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the patient's skin so as to transmit this stimulus current to the patient for pain relief.
The stimulation mode for Mini-TENS is burst mode with fixed pulse rate, frequency, and fixed timer. Only amplitude is adjustable. This operation way is considered the simplification from the burst mode of comparison clear model, WL-2102A. Every model of Mini-TENS has its individual stimulation operation cycle.
The Mini-TENS series (WL-2401, WL-2402, WL-2403, and WL-2302) are almost identical in function outlook and specification.
This document describes the 510(k) summary for the Well-Life Mini-TENS series (models WL-2401, WL-2402, WL-2403, and WL-2302), which are transcutaneous electrical nerve stimulators (TENS devices). The purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device (Well-TENS, model WL-2102A).
This submission does not contain information related to the performance of an AI/ML device in the context of acceptance criteria from a study. It focuses on the comparison of specifications and intended use of new TENS device models against a predicate TENS device for 510(k) clearance. Therefore, a table of acceptance criteria and reported device performance isn't applicable in the context of an "AI/ML device" and a study proving it meets acceptance criteria.
However, I can extract the comparative information presented in the document, which serves as the basis for determining substantial equivalence for these medical devices.
Summary of Device Comparison and Non-Clinical Tests (as presented in the 510(k) submission):
The document presents a comparison of the new Mini-TENS series with the predicate device (WL-2102A) to demonstrate substantial equivalence. The "acceptance criteria" here implicitly refer to the notion that the new devices should not raise new questions of safety or effectiveness, and their characteristics should be comparable to or within acceptable limits relative to the predicate device and relevant standards.
Table of Performance Comparisons for Substantial Equivalence (derived from the document):
| Feature/Specification | Predicate Device (WL-2102A) | New Device Models (WL-2401, WL-2402, WL-2403, WL-2302) | Comments on Equivalence |
|---|---|---|---|
| Intended Use | Pain relief (TENS device) | Symptomatic relief of chronic intractable pain | Same intended use |
| Operation Mode | 3 modes (B/C/M) | 1 mode (Burst mode) | Simplified operation, considered safe and effective by comparison to predicate's burst mode. |
| Output Channels | 2 | 1 | Different, but not raising new safety/effectiveness concerns. |
| Power Source | 1x9V Alkaline, Type BF | 1x3V Lithium, Type BF | Different battery, but still Type BF for isolation and leakage current within limits. |
| Normal Condition Line Current Isolation |
§ 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).