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POWERTONE PT-11 is intended to be used for:

• Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of a firmer abdomen.
• Strengthening, toning and firming of buttocks & thigh .

Powertone is a Muscle stimulator with two different outputs. This battery powered unit is designed for men & women to provide exercise technology anytime-whether relaxing at home or to use as a part of exercise routine . The stimulation is the most comfortable & this technology makes it easier to combine active & passive exercise.
PT-11 stimulator provides selections of different programs through one output to treat Abdominal muscles (ABS) & through two outputs Bottom /Thighs muscles (BTS). Four body areas can be treated. LCD shows the selected program & balance treatment time.
The MKB panel with the LCD simplifies the selections. This unit is ergonomically designed, being portable it is easy and simple to use, yet works as a Clinical model (two output channels) rechargeable batteries power it. The unit can perform anytime & anywhere. Powertone is suitable for use by all healthy adults. However as with other form of exercise, some care is needed when using them. The electrical muscle stimulator (Powertone) contracts muscles rhythmically to achieve muscle tone and strength. This unit contains six self-adhesive electrodes, which can be fixed to the belt with buttons.

This document is a 510(k) premarket notification for the Powertone PT-11 muscle stimulator. It does not contain information about acceptance criteria or a study proving device performance against such criteria. Instead, it describes the device, its intended use, and establishes its substantial equivalence to previously marketed devices.

Therefore, I cannot provide the requested information from the provided text. The document focuses on regulatory approval based on equivalence rather than clinical study results demonstrating performance against specific acceptance criteria.

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