- (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.
[91 FR 31897, May 29, 2026]