FDA product code QZO

Wearable Vibration Device For Orthopedic Use

Orthopedic·Class 2·21 CFR 888.5895
US regulatory classifications
US Product Code (FDA)
QZO
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 888.5895
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Medical specialty
Orthopedic
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

A wearable vibration device for orthopedic use is a wearable device that uses mechanical vibrations, targeted to specific regions of the skeleton, to reduce loss of bone strength or bone mineral density.

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About this record

Wearable Vibration Device For Orthopedic Use is a medical device type in the Orthopedic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.