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Open for comment Health and Human Services Department, Food and Drug Administration Docket Docket No. FDA-2026-N-12211

FDA Classifies Wearable Vibration Device for Orthopedic Use as Class II Medical Device

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FDA Classifies Wearable Vibration Device for Orthopedic Use as Class II Medical Device

Establishes special controls for a new orthopedic device category, providing regulatory clarity while balancing safety and access. The FDA has classified the wearable vibration device for orthopedic use as a Class II medical device, subject to special controls.

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Health and Human Services Department, Food and Drug Administration · Medical Devices; Orthopedic Devices; Classification of the Wearable Vibration Device for Orthopedic Use · Nov 5