Search Results

The OTC TENS for Arm & Leg Pain Relief / model WL-2407 are intended for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

The Well Life TENS devices, WL-2407 is the model of OTC TENS intended for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. Basically the stimulation model WL-2407 is completely identical to that of model as mentioned in the Well-Life K063660- 510(K) cleared device. To change the indication for use for the treatment location as the chosen predicate devices. Well-Life change the design of electrode.

For the device included in this submission, we use the following third party 510(K) legally marketed predicate components: K022494, the Home Care Jelly.

WL-2407 is a selectable dual channel, 4.5V (3xAAA/Alkaline battery) operated TENS device with the following features:

• The operation function is dual channels completely identical to the model being modified, WL-2407 for low back pain relief(K063660).
• For the stimulation electrode. Well-Life uses upper arm belt as well as snap type adhesive electrode as standard accessories.
• The output waveform is selectable pre-programming change among P1~P8.
• The output strength is adjustable at 0~80 mA, with setting time 21 minutes counting from switchina ON.
• The LCD display is provided for the indication of operation status including operation mode, output program mode, output intensity, time to cut-off, and battery low warning.

The provided text describes a 510(k) summary for the "OTC TENS for Arm & Leg Pain Relief / Model: WL-2407". This device is a Transcutaneous Electrical Nerve Stimulator (TENS) intended for temporary relief of pain in the upper and lower extremities.

The relevant section for acceptance criteria and the study proving the device meets them is Section 6, "Power level testing comparison and acknowledge of comparison result with Prizm 5000Z system", and Section 7, "Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence".

Here's an analysis of the provided information:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria here are implicitly based on demonstrating "lower output power and power density" compared to the predicate device, the Prizm 5000-Z system, under standardized 1K ohm loading resistance. This is presented as proving safety rather than effectiveness in this specific comparison.

Note: The reported current for "Sleeve & Knee" for WL-2407 (0.00386) is slightly higher than for Prizm 5000-Z (0.00385). The document acknowledges that "the model WL-2407 has a lower output power and power density than that of Prizm 5000-Z system while using the same electrode". This suggests that the slight increase in current for "Sleeve & Knee" was deemed acceptable given the overall trend of lower power and power density, or perhaps due to rounding in the provided data. The focus seems to be on overall safety margins.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The described testing is a non-clinical, benchtop comparison of electrical output parameters. Therefore, there is no human "test set" or data provenance in the sense of patient data. The "test set" would refer to the electrical measurements taken from the device and the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This type of information is not applicable to this submission. The "ground truth" for the electrical output comparison is the objective measurement of current and power density using specified loading resistance. This does not involve expert interpretation or clinical ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are used to establish ground truth in studies involving human interpretation (e.g., medical imaging reads). This submission describes objective electrical measurements.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was done. This device is a TENS unit, not an AI-powered diagnostic tool. The submission focuses on substantial equivalence based on technical characteristics and safety, not on human reader performance with or without AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device (TENS unit), not an algorithm or software. The performance is assessed through direct electrical measurements, not algorithmic output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this particular demonstration is the physical measurement of electrical output parameters (current and power density) under specific, controlled conditions (1K ohm loading resistance). This is an objective, quantitative measurement rather than a subjective or clinical "ground truth."

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."

9. How the ground truth for the training set was established

Not applicable. As there is no training set, there is no ground truth for it to be established.

Ask a specific question about this device