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U.S. Department of Health and Human Services

Product Classification
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Device wearable vibration device for orthopedic use
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.
Physical State Vibrator hardware. The device may include a motor, pressure sensor, and accelerometers within a casing, seated on a belt. The device may include software to regulate the magnitude of vibration generated and to control treatment duration.
Technical Method Consists of a vibration pack which incorporates a motor that is designed to transmit low-amplitude, high-frequency vibration to the skeleton.
Target Area Skeleton, excluding the skull and face.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeQZO
Premarket Review Office of Orthopedic Devices (OHT6)
Restorative, Repair and Trauma Devices (DHT6C)
Submission Type 510(k)
Regulation Number 888.5895
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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