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MT9001 OTC TENS/EMS stimulator
TENS: The device is designed to be used 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.
EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
LT3060 OTC TENS stimulator
TENS: The device is designed to be used 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.

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This document is an FDA 510(k) clearance letter for two OTC Electrical stimulator models (MT9001, LT3060). It acknowledges that the devices are substantially equivalent to legally marketed predicate devices.

However, this document does not contain information about acceptance criteria for a study, nor does it present the results of a study to prove a device meets those criteria.

The letter is a regulatory approval, not a scientific study report. Therefore, I cannot extract the requested information from the provided text.

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