FDA classifies wearable vibration device for orthopedic use as class II
The FDA finalized an order classifying the wearable vibration device for orthopedic use into class II with special controls, stating the classification will provide a reasonable assurance of the safety and effectiveness of the device. The agency said the action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Primary source
Federal Register rule, November 5, 2026
Medical Devices; Orthopedic Devices; Classification of the Wearable Vibration Device for Orthopedic Use
Read the source: Medical Devices; Orthopedic Devices; Classification of the Wearable Vibration Device for Orthopedic Use federalregister.gov
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