21 CFR §872.5575

1. (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.
2. (b)Classification. Class II (special controls). The special controls for this device are:
   1. (1)Performance testing must demonstrate the wireless compatibility, electrical safety, battery safety, and electromagnetic compatibility of the device in its intended use environment.
   2. (2)Software verification, validation, and hazard analysis must be performed.
   3. (3)The patient-contacting components of the device must be demonstrated to be biocompatible.
   4. (4)Patient labeling must include:
      1. (i)Information on device components, setup, and use of the device including placement of sensors and mouthpieces, and images or illustrations;
      2. (ii)A summary of technical specifications;
      3. (iii)Instructions on how to clean and maintain the device;
      4. (iv)A statement that the patient should maintain regular follow up visits with dentist and sleep specialist; and
      5. (v)A statement that patients should have a comprehensive dental examination prior to using this device.
   5. (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.