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U.S. Department of Health and Human Services

Product Classification
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Device extracorporeal shock wave treatment
Definition For use for extracorporeal shock wave treatment of atrophic nonunion fractures. The device delivers a shock wave to the patient via a water-filled coupling membrane whic is intented to help atrophic nonunion fractures heal.
Physical State Length of arm 600/700mm, Reflecture aperture: 620-1010mm, weight: 152 kg
Technical Method The device delivers a shock wave to the patient via a water-filled coupling membrane whic is intented to help atrophic nonunion fractures heal.
Target Area Bone that has an atrophic nonunion fracture
Review Panel Orthopedic
Product CodeOME
Premarket Review Office of Orthopedic Devices (OHT6)
Restorative, Repair and Trauma Devices (DHT6C)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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