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Everyway Analog OTC TENS, model N601L is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

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The provided text is a 510(k) clearance letter from the FDA for a Transcutaneous Electrical Nerve Stimulator (TENS) device. This document does not contain information on the acceptance criteria, study details, or performance metrics of the device as it would typically be presented in a clinical or validation study report.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the device was cleared based on its substantial equivalence to a predicate device, rather than through a dedicated study demonstrating performance against specific clinical acceptance criteria.

Therefore, I cannot extract the requested information from the provided text. To answer your questions, I would need access to the full 510(k) submission, device validation reports, or clinical study data if such studies were conducted and included in the submission.

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Everyway Analog OTC TENS, model N103A/N302 is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

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The provided text is a 510(k) clearance letter from the FDA for a medical device called "Everyway Analog OTC TENS, model N103A/N302." This document primarily focuses on the regulatory clearance process and does not contain information regarding the acceptance criteria, specific performance study details, or ground truth establishment for a medical device's AI or standalone performance.

Therefore, I cannot fulfill your request for the detailed information outlined in points 1-9 based on the provided text. The document confirms that the device is a Transcutaneous Electrical Nerve Stimulator For Pain Relief and is cleared for Over-The-Counter Use for temporary relief of pain associated with sore and aching muscles. However, it does not describe the technical performance evaluation or clinical study results that would typically be associated with AI or standalone device performance testing.

Ask a specific question about this device