Search Results

TENS:

[RS-18, RS-28, RS-38 models]: For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.

[RS-18, RS-38 models]: For temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medications.

[RS-18, RS-28 models]: It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

EMS:

[RS-18. RS-28]: To stimulate healthy muscles in order to improve and facilitate muscle performance.

Environments of Use: Clinics, hospital and home environments (over-the-counter) Patient Population: Adult

"Wireless Electrical Stimulator" is a battery-powered wireless electrical stimulator designed and intended to provide Transcutaneous Electrical Nerve Stimulation (TENS) and Electrical Muscular Stimulation (EMS) for the use of non-pharmacological pain relief and improve muscle performance and recovery.

The "Wireless Electrical Stimulator" includes a remote control, stimulator pod(s) and several accessories. Both the remote control and the stimulator pod are powered by a 3.7V lithium-ion polymer battery. The remote control has a 1.77" TFT LCD screen and 4 buttons to control multiple stimulator pod(s) at the same time. Each stimulator pod has two output channels, and will perform electrical stimulation according to the parameter settings sent by the remote control. The stimulator pods can also be used independently via its own 3 buttons based on preset parameter.

The accessories include self-adhesive electrodes, kneelelbow brace, and the USB Type-C charging cable. The adhesive electrodes for "Wireless Electrical Stimulator" are connected with the Stimulator Pod(s) via magnetic snap and lead wire. There are replaceable hydrogel pads on the self-adhesive electrode pads. Users can replace the hydrogel when it exceeds its useful life, but does not need to discard the entire electrode. To apply electrical stimulation to body joints (e.g. knees and elbows), users can easily place electrodes on specific body parts using the Knee/elbow brace. The remote control and stimulator pods are the same for all models. The 3 models have different accessories to match their specific usage instructions.

The provided text is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) / Electrical Muscle Stimulator (EMS) device. It details the device's characteristics, comparison to predicates, and performance testing for FDA clearance.

However, the provided text DOES NOT contain the type of AI/ML-specific acceptance criteria and study information requested in the prompt. The device is a medical stimulator, not an AI/ML-driven diagnostic or prognostic tool. Therefore, information like "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the-loop performance)," "ground truth established by experts/pathology," or sample sizes for training/test sets for AI models are not applicable to this document.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices through comparisons of indications for use, technological characteristics, and various non-clinical performance data (biocompatibility, electrical safety, EMC, software verification, human factors, bench testing).

Therefore, I cannot populate the requested table or answer the specific questions related to AI/ML acceptance criteria and studies based on the provided text.

Ask a specific question about this device