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Specific indications: used to apply an electrical current to electrodes on patient's skin to function as:

• Relaxation of muscle spasms;
• Prevention or retardation of disuse atrophy
• Muscle re-education
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Maintaining or increasing range of motion.
• Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for the treatment of medical diseases and conditions.

Home Care various models of Powered Muscle Stimulator, HT-311, HT-311N, HT-312

I apologize, but this document is a 510(k) clearance letter from the FDA for a Powered Muscle Stimulator. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter focuses on:

• Confirming that the device is substantially equivalent to legally marketed predicate devices.
• Outlining the regulatory classification and general controls provisions that apply to the device.
• Listing the indications for use for which the device was cleared.

Therefore, I cannot provide the requested information based on the provided text.

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