(a) Identification. A transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms is a prescription device that transcutaneously stimulates a patient's sensory nerves through electrodes placed on the skin to treat fibromyalgia symptoms.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. This testing must include:

(i) Characterization of the electrical stimulation parameters, including the following: waveforms; output modes; maximum output voltage and maximum output current (at 500Ω, 2kΩ, and 10kΩ loads); pulse duration; frequency; net charge per pulse; maximum phase charge, maximum current density, maximum average current, and maximum average power density (at 500Ω);

(ii) Characterization of the impedance monitoring system; and

(iii) Characterization of electrode performance, including the electrical performance, adhesive integrity, shelf life, reusability, and current distribution of the electrode surface area.

(2) The patient-contacting components of the device must be demonstrated to be biocompatible.

(3) Performance testing must demonstrate electrical, thermal, and mechanical safety along with electromagnetic compatibility of the device in the intended use environment.

(4) Software verification, validation, and hazard analysis must be performed.

(5) Labeling must include the following:

(i) Recommended treatment regimes, including but not limited to, frequency and duration of use, application site(s), and typical sensations experienced during treatment;

(ii) A shelf life for the electrode and reuse information;

(iii) Summaries of the electrical stimulation parameters and device technical parameters (including any wireless specifications); and

(iv) Instructions on how to correctly use and maintain the device, including all user-interface components.