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The "Elexoma Medic" is a battery operated portable cranial electrotherapy stimulator (CES) device that applies electrical current to a patient's head through electrodes clipped onto the patient's earlobes to treat insomnia, depression, or anxiety and The "Elexoma Medic" is a battery operated portable transcutaneous electrical nerve stimulator (TENS) device used to apply microcurrent through self-adhesive electrodes to a patient's skin for the symptomatic relief of intractable pain, chronic intractable pain, post-traumatic and postsurgical pain relief. The "Elexoma Medic" is a prescription device according to Federal law.

The "Elexoma Medic" is a battery operated portable cranial electrotherapy stimulator (CES) device that applies electrical current to a patient's head through electrodes clipped onto the patient's earlobes and a battery operated portable transcutaneous electrical nerve stimulator (TENS) device used to apply microcurrent through self-adhesive electrodes to a patient's skin.

The provided document is an FDA 510(k) clearance letter for the Elexoma Medic device. It states that the device is substantially equivalent to a legally marketed predicate device.

However, this document does not contain information about specific acceptance criteria for performance, nor does it detail a study proving the device meets particular performance metrics.

The letter focuses on the regulatory clearance process and substantial equivalence, not on the detailed technical performance study results. Therefore, I cannot provide the requested information based solely on this document.

To answer your questions thoroughly, I would need access to the 510(k) submission itself, which would include the performance data and methodologies used to demonstrate substantial equivalence.

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