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The T.E.A.R. Tech3 IF/Muscle Stimulator is intended for the following applications:

The High Volt Pulsed Current Stimulation and Neuromuscular Electrical Stimulation can be used in the following applications:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy .
• Increases local blood circulation .
• Muscle re-education •
• Maintaining or increasing range of motion
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

Interferential Stimulation can be used in the following applications:

• Symptomatic relief of post traumatic acute pain
• . Symptomatic relief of chronic pain intractable pain
• . Relaxation of muscle spasms
• Maintaining or increasing range of motion
• Increases local blood circulation

Pulsed Direct Current stimulation can be used in the following applications:

• Reduction of edema (under negative electrode)
• Relaxation of muscle spasm
• . Increasing local blood circulation
• Retardation or prevention of disuse atrophy
• Muscle re-education
• Maintaining or increasing of range of motion

The T.E.A.R. Tech 3 IF/Muscle Stimulator is a device which combines the functionality of Interferential (IF), Neuromuscular (NM), High Voltage (HV) and Pulsed Direct Current (PDC) in one device. The device produces a low electrical current that is transmitted via lead wires to electrodes placed on the area predetermined by a clinician. Operating parameters can be adjusted throughout their range by a trained clinician but the end-user is limited to protocol selection and amplitude. The user interface consists of an LCD display and keypad.

This 510(k) summary does not contain details about acceptance criteria or a study proving device performance against such criteria.

The document is a 510(k) submission for an Interferential/Muscle Stimulator (T.E.A.R. Tech 3). It focuses on establishing substantial equivalence to previously cleared devices based on design, composition, and intended use.

Therefore, I cannot populate the table or answer the questions regarding acceptance criteria and performance studies, as that information is not present in the provided text. The document primarily describes the device, its indications for use, and its substantial equivalence to other predicate devices, which is typical for a 510(k) summary seeking market clearance.

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