The Food and Drug Administration (FDA) is classifying the wearable vibration device for orthopedic use into class II (special controls) effective November 5, 2026. According to the FDA, this classification will provide a reasonable assurance of the safety and effectiveness of the device and enhance patients' access to beneficial innovative devices. The classification was applicable on January 12, 2024, and details can be found in the Federal Register document.

Press Release: Food and Drug Administration

Published November 5, 2026. Reproduced in full from the Food and Drug Administration.

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

Action: Final amendment; final order.

Summary

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.

Key dates

  • Takes effect: November 5, 2026

This order is effective November 5, 2026. The classification was applicable on January 12, 2024.

Full text: Federal Register document 2026-22589