Orthofix AccelStim Manual De Instrucciones página 37

Conclusions Drawn from the Studies
The information provided provides reasonable assurance of the safety and
effectiveness of the AccelStim device for the noninvasive except skull and vertebra
treatment of established nonunions, fresh, closed, posteriorly displaced distal radius
fractures and fresh, closed, or Grade I open tibial diaphysis fractures. Clinical studies
leveraged to support the safety and effectiveness of the AccelStim device may not
necessarily be applicable to patients of all races and ethnicities. Such demographic
details were not provided in the referenced clinical studies.
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