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The RS-4i Sequential Stimulator is indicated for use as adjunctive therapy in reducing the level of pain associated with osteoarthritis of the knee.

The RS-4i Sequential Stimulator consists of a hardware/software svstem that is the same as was described in its previous 510(k) notification (K032652). The RS-4i Sequential Stimulator also includes a TENS output. The RS-4i Sequential Stimulator incorporates traditional muscle stimulation and interferential current stimulation modalities, as well as TENS output into one unit. Only one modality may be operated at a time, but modalities can be automatically sequenced. The RS-4i is housed in a plastic enclosure. The front of the enclosure houses the LCD patient display and the operator keypad. The accessories provided with the RS-4i include the output cables, the electrode pads, and the AC Charging Adapter.

The provided text is a 510(k) summary for the RS-4i Sequential Stimulator, a medical device. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The document primarily focuses on describing the device, its indications for use, and its substantial equivalence to predicate devices, which is typical for a 510(k) submission. Therefore, I cannot extract the requested information from this text.

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