---
kind: "section"
citation: "21 C.F.R. § 882.5895"
title: "21"
number: "882.5895"
heading: "Vibratory counter-stimulation device."
url: "https://uscodex.org/cfr/21/882.5895"
---

# §882.5895. Vibratory counter-stimulation device.

- (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](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 882.9](/cfr/21/882.9.md). 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.

## Notes

### Amendments

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

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.

### Amendments

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