2024-19725. Medical Devices; Dental Devices; Classification of the Neuromuscular Tongue Muscle Stimulator for the Reduction of Snoring and Obstructive Sleep Apnea

Table 1—Neuromuscular Tongue Muscle Stimulator for the Reduction of Snoring and Obstructive Sleep Apnea Risks and Mitigation Measures

Identified risks to health	Mitigation measures
Adverse tissue reaction	Biocompatibility evaluation.
Interference with other devices/electrical shock	Electrical safety testing, Electromagnetic compatibility (EMC) testing, Battery safety testing, Wireless coexistence testing, and Labeling.
Use error leading to pain, discomfort, or injury	Human factors assessment; Software verification, validation, and hazard analysis; Electrical safety testing; and Labeling.
Mucosal or skin overheating or burn	Software validation, verification, hazard analysis; Electrical safety testing; Electromagnetic compatibility (EMC) testing; and Labeling.
Infection	Labeling.