§ 882.5887 External lower extremity nerve stimulator for Restless Legs Syndrome.
(a)Identification. An external lower extremity nerve stimulator for Restless Legs Syndrome is a prescription device that uses external electrical stimulators and cutaneous electrodes to stimulate nerves in the lower extremity (e.g., peroneal nerves) and evoke tonic, sustained muscle activation in the legs to reduce the symptoms of Restless Legs Syndrome.
(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;
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§ 882.5887 External lower extremity nerve stimulator for Restless Legs Syndrome.
(a) Identification. An external lower extremity nerve stimulator for Restless Legs Syndrome is a prescription device that uses external electrical stimulators and cutaneous electrodes to stimulate nerves in the lower extremity (e.g., peroneal nerves) and evoke tonic, sustained muscle activation in the legs to reduce the symptoms of Restless Legs Syndrome.
(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; and maximum phase charge, maximum current density, maximum average current, and maximum average power density (at 500Ω);
(ii) Characterization of the therapy output across sudden and rapid changes in load impedance; and
(iii) Characterization of electrode performance, including electrical performance, adhesive integrity, shelf life, reusability, and variation of impedance over the use of therapy.
(2) The tissue-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) Physician and patient labeling must include the following:
(i) Recommended treatment regimens, including frequency and duration of use, and identification of application site(s);
(ii) Typical sensations experienced during treatment;
(iii) Methods for identifying the appropriate stimulation intensity that is needed to reduce symptoms of Restless Legs Syndrome and is tolerable to patients;
(iv) A shelf life for the electrode and reuse information;
(v) Summaries of the electrical stimulation parameters and device technical parameters (including any wireless specifications); and
(vi) Instructions on how to maintain the device, including all user-interface components.
[91 FR 38510, June 26, 2026]