Final rule · 2026-22589

Medical Devices; Orthopedic Devices; Classification of the Wearable Vibration Device for Orthopedic Use

The Food and Drug Administration (FDA) is classifying the wearable vibration device for orthopedic use 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 classification of the wearable vibration device for orthopedic use. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.