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FDA classifies wearable bone-vibration devices class II

FDA published a final order classifying wearable vibration devices for orthopedic use as class II with special controls. The device type is a wearable that uses mechanical vibrations aimed at specific skeleton regions to reduce loss of bone strength or bone mineral density. It remains prescription-path 510(k) gear, not a home DIY cure, and labeling must cover duration, limits of clinical testing, and risks such as pain, dizziness, and balance trouble.

Who it covers

Everyone

Official source

U.S. Food and Drug Administration (Federal Register)

Checked on

November 12, 2026. We opened the official page and confirmed the wording and every number.

to reduce loss of bone strength or bone mineral density