# Medical Devices; Dental Devices; Classification of the Neuromuscular Tongue Muscle Stimulator for the Reduction of Snoring and Obstructive Sleep Apnea
> **Food and Drug Administration** · Final amendment; final order. · Published 2024-09-03 · Effective 2024-09-03 · 89 FR 71153
## Document
- **Document number:** 2024-19725
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 89 FR 71153
- **CFR reference:** 21 CFR 872
- **Publication date:** 2024-09-03
- **Effective date:** 2024-09-03
- **HHS docket:** Docket No. FDA-2024-N-3948
## Abstract

The Food and Drug Administration (FDA, Agency, or we) is classifying the neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2024/09/03/2024-19725/medical-devices-dental-devices-classification-of-the-neuromuscular-tongue-muscle-stimulator-for-the)
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