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The device of this submission is designed to temporarily relieve muscle soreness and pain in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom caused by exercise or normal household activities. Also used to stimulate healthy muscles to improve muscle performance.

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The provided text is an FDA clearance letter for a medical device: "TENS and EMS Unit." This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.

Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a 510(k) summary.

The letter is a regulatory document stating market clearance and does not detail the technical performance or supporting studies for the device. Instead, it refers to the device's "Indications for Use" and mentions regulatory compliance.

Therefore, I cannot provide the requested information from the given text.

To answer your questions, I would need access to the 510(k) summary or the full 510(k) submission for K251706, which would typically contain the performance data and details of any studies conducted.

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