(51 days)
APPLICABLE FOR EV-804 (TENS) AND EV-806 (TENS/EMS COMBINATION UNIT):
This device is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for (1) Symptomatic relief and management of chronic (long term) intractable pain and (2) adjunctive treatment in the management of post surgical and post traumatic pain problems
APPLICABLE FOR EV-805 (EMS) AND EV-806 (TENS/EMS COMBINATION UNIT):
This device is an electrically powered muscle stimulator indicated for use for medical purposes to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular, this device is indicated for use for (1) Relaxing muscle spasms, (2) Increasing local blood circulation, (3) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, (4) Muscle re-education, (5) Maintaining or increasing range of motion, and (6) Preventing or retarding disuse atrophy
The Comfy Series, which includes models EV-804, EV-805, EV-806, are Transcutaneous Electrical Nerve Stimulator for pain relief and/or Electrical Muscle Stimulator. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of units are controlled by the press buttons. Its intensity level is adjustable according to the needs of patients.
The three models have the same housing. The process to set the parameter and attach lead wires to the unit are also the same. Yet, they have different liguid crystal display and parameters for patients to create their own settings.
The EV-804 is a TENS device with 5 modes and adjustable pulse rate, pulse width and timer. The EV-805 is an EMS device with 3 modes and adjustable pulse rate, pulse width, contraction time, relaxation time, ramp time and timer. The EV-806 is a combination unit with both TENS and EMS functions. The function can be selected by press buttons. The range of settings are identical to those of EV-804 and EV-805. The difference on the three units can be identified by the liquid crystal display.
The provided text is a 510(k) summary for the Comfy series of TENS/EMS devices (Models EV-804, EV-805, EV-806). This type of submission focuses on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than conducting new clinical studies with defined acceptance criteria for device performance.
Therefore, the document does not contain the kind of information requested in the prompt, such as specific acceptance criteria, a study proving device performance against those criteria, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
Instead, the submission relies entirely on the premise that the new devices are safe and effective because they are substantially equivalent to previously cleared devices (Everyway Medical Instruments Co., Ltd.'s Digital TENS model EV-803, 510k# K020749, and Digital EMS model EV-807, 510k# K020750).
Here's a breakdown of why the requested information is absent:
- Acceptance Criteria and Reported Performance: The document states, "This series is safe and effective as the predicate devices cited above. The design modifications that EV-803 and EV-807 underwent did not affect safety and effectiveness of the new series EV-804, EV-805 and EV-806 as detailed within this submission." There are no new performance metrics or acceptance criteria presented because the claim is an equivalence to existing, already-cleared devices.
- Study Design/Sample Sizes/Data Provenance/Ground Truth/Adjudication/MRMC/Standalone Performance: These elements are typical of de novo clinical studies demonstrating the safety and effectiveness of a novel device. For a 510(k) based on substantial equivalence, especially for a device like a TENS/EMS unit with well-established technology, such studies are generally not required if the new device can be shown to have the same intended use, technological characteristics, and performance characteristics as a predicate device, or if any differences do not raise new questions of safety and effectiveness.
In summary, the provided text does not describe a study to prove the device meets acceptance criteria in the way a novel device might. It describes a submission to the FDA based on substantial equivalence.
§ 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).