(a) Identification. A vibratory counter-stimulation device is a prescription device that provides electrically powered mechanical vibration to improve the quality of sleep in patients with primary Restless Legs Syndrome.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §882.9. The special controls for this device are:

(1) Appropriate analysis/testing must demonstrate electromagnetic compatibility (EMC), electrical safety, and thermal safety.

(2) If the device contains software or firmware, appropriate verification, validation, and hazard analysis must be performed.

(3) The elements of the device that contact the patient must be assessed to be biocompatible.

(4) Non-clinical testing data (including vibration frequency, amplitude, and acceleration) must demonstrate that the device performs as intended under anticipated conditions of use.

(5) Labeling must include:

(i) Specific information pertinent to use of the device by the intended patient population and the treatment regimen;

(ii) Warning to only use the device on normal, intact, clean, healthy skin;

(iii) Warning to not use the device if the user has leg skin disorders, such as eczema, psoriasis, cellulitis, non-healing wounds;

(iv) Warning to discontinue use if Restless Leg Syndrome symptoms worsen; and

(v) Instructions for end users to contact the device manufacturer and MedWatch in case they experience any adverse events when using this device.

[82 FR 13554, Mar. 14, 2017, as amended at 84 FR 71815, Dec. 30, 2019]