---
kind: "section"
citation: "21 C.F.R. § 872.5575"
title: "21"
number: "872.5575"
heading: "Neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea."
url: "https://uscodex.org/cfr/21/872.5575"
---

# §872.5575. Neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea.

- (a) **Identification.** A neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea consists of a removable intraoral mouthpiece that uses electrodes to deliver neuromuscular stimulation to the tongue to strengthen tongue musculature to reduce snoring and obstructive sleep apnea.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Performance testing must demonstrate the wireless compatibility, electrical safety, battery safety, and electromagnetic compatibility of the device in its intended use environment.
  - (2) Software verification, validation, and hazard analysis must be performed.
  - (3) The patient-contacting components of the device must be demonstrated to be biocompatible.
  - (4) Patient labeling must include:
    - (i) Information on device components, setup, and use of the device including placement of sensors and mouthpieces, and images or illustrations;
    - (ii) A summary of technical specifications;
    - (iii) Instructions on how to clean and maintain the device;
    - (iv) A statement that the patient should maintain regular follow up visits with dentist and sleep specialist; and
    - (v) **A statement that patients should have a comprehensive dental examination prior to using this device.**
  - (5) A human factors assessment must evaluate simulated use of the device to demonstrate that the user can correctly use device based on the labeling and instructions for use.

## Notes

### Amendments

[89 FR 71154, Sept. 3, 2024]

### Authority

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

### Source

Source: 52 FR 30097, Aug. 12, 1987, unless otherwise noted.

### Amendments

[89 FR 71154, Sept. 3, 2024]