Skip to main content
Find a Lawyer

Code of Federal Regulations Title 21. Food and Drugs § 21.882.5895 Vibratory counter-stimulation device

Current as of January 02, 2025 | Updated by Findlaw Staff

(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.

Previous Part of Code Next Part of Code
Back to Chapter List

Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.882.5895 Vibratory counter-stimulation device - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-882-5895/

FindLaw Codes may not reflect the most recent version of the law in your jurisdiction. Please verify the status of the code you are researching with the state legislature before relying on it for your legal needs.

Was this helpful?

Welcome to FindLaw's Cases & Codes

A free source of state and federal court opinions, state laws, and the United States Code. For more information about the legal concepts addressed by these cases and statutes, visit FindLaw’s Learn About the Law.

Go to Learn About the Law

Latest Blog Posts

For Legal Professionals

Learn About The Law

Get help with your legal needs

FindLaw’s Learn About the Law features thousands of informational articles to help you understand your options. And if you’re ready to hire an attorney, find one in your area who can help.

Go to Learn About the Law

Need to Find an Attorney?

Search our directory by legal issue

Enter information in one or both fields (Required)

Copied to clipboard