(60 days)
TENS device-EmeTerm 2 is a wearable device for the treatment of nausea and vomiting caused by motion sickness and pregnancy.
TENS device-EmeTerm 2 is a single-patient use wearable device, rechargeable, non-invasive device that is worn on the wrist like a watch. It is a non-invasive device that is indicated for the over-the-counter use in the relief of mild to moderate nausea and vomiting, motion sickness, mild to moderate nausea and vomiting associated with pregnancy.
TENS device-EmeTerm 2 includes a Rubber wristband with two electrodes must be placed at the center of the inner wrist, about 2 to 3cm from the wrist crease. The electrodes in the wristband provide relief of nausea and vomiting through electrical stimulation of the median nerve on the ventral side of the patient's wrist.
This is a submission for a TENS device, which is not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, human reader performance, ground truth, and training set information is not applicable in this context. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data and adherence to recognized standards.
§ 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).