Federal Register #2026-22657

FDA Class II classification for external mechanical stimulators used for congestion relief

The FDA issued a regulatory classification order for external mechanical stimulators intended to relieve congestion; this notice is not a procurement opportunity. - Issuing agency: U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA). The FDA is the regulatory authority, not a purchasing agency. - OEM/requester named: Sound Health Systems, Inc., identified as the requester of De Novo classification for its Sonu device. No other vendors are named. - Device type: External mechanical stimulators that deliver vibrations to the sinus and nasal areas for congestion relief. No products, quantities, or part numbers are being solicited for purchase. - Classification and requirements: Class II under 21 CFR 874.6010, with special controls covering non-clinical performance testing, electrical and battery safety, electromagnetic compatibility, software verification and validation, biocompatibility, human factors testing, and labeling. The device type remains subject to 510(k) premarket notification requirements.

Description

The FDA classifies the external mechanical stimulator for the relief of congestion as a class II medical device subject to special controls. The device delivers vibrations to the sinus and nasal areas to relieve congestion. The order codifies the classification in 21 CFR 874.6010 and identifies special controls, including performance, safety, software, biocompatibility, human factors, and labeling requirements. The device is subject to premarket notification requirements under section 510(k).

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