(129 days)
The indication for use of this device includes the prescription TENS, NMS, Interferential stimulation as follows:
Transcutaneous Electrical Nerve Stimulator (TENS/IF TENS) & Program can be used for the following applications :
· For symptomatic relief of chronic intractable pain.
Neuromuscular electrical stimulation (NMS) & Program stimulation can be used for the following applications :
- · Relax muscle spasms
- · Prevent or retard disuse atrophy
- Increase local blood circulation
- · Re-educate muscles
- Maintain or increase the range of motion
The Well-Life 4 Channels Multiple Modes Electrical Stimulator/ Model: WL-2504A is the The Well-che of Channels Matiple Motion Leorve stimulator(TEMS) and Interferential Combination (IF) used for pain relief and/or powered muscle stimulator(EMS) by applying Stimulation (if ) ascu for pain rollor which are attached on the patient's skin. The output and waveform is adjustable according to the situation of patient.
The Well-Life 4 Channels Multiple Modes Electrical Stimulator/ Model: WL-250A consisted The Well-Life + Chamble Modisle Model Eloctive. The stimulus generator generator generator summer mainly of two parts. the stimulas gonorator, close. The output port transmits the output current oulput current Specificular to the patient's skin so as to transmit this stimulus current to the patient for pain relief or muscle stimulation of intended use purpose.
The Well-Life 4 Channels Multiple Modes Electrical Stimulator/ Model: WL-2504 includes The Well-Life + Channels Modes as mentioned on the comparison table. These its moin several unlerent operation modes as montonou on the microprocessor as its main control unit.
Here's a breakdown of the acceptance criteria and the study information based on the provided 510(k) summary:
This device (Well-Life 4 Channels Multiple Modes Electrical Stimulator/ Model: NuvoStim IV, WL-2504A) is an electrical stimulator. The 510(k) summary focuses primarily on demonstrating substantial equivalence to predicate devices through technical specifications and compliance with voluntary standards, rather than a clinical study evaluating diagnostic accuracy or reader performance typically associated with AI/imaging devices.
Therefore, many of the requested points related to AI studies, ground truth, and expert adjudication are not applicable to this type of device submission.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct pass/fail thresholds in the provided text. Instead, the "performance" shown is in the form of electrical output ranges for various functions of the device, which are implicitly compared to the performance of predicate devices. The claim of the study is that these output characteristics are "identical" or "substantial equivalent" to the predicate devices.
Table of Acceptance Criteria and Reported Device Performance:
| Function | Operation Function | Acceptance Criteria (Implicit) | Reported Device Performance (WL-2504A) |
|---|---|---|---|
| Current Density Range (mA/cm²) (measured against 500Ω loading at maximum pulse rate) | IF TENS | Output characteristics substantially equivalent to predicate (WL-2206D) | Minimum: |
§ 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).