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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceAccelStimTM Bone Growth Stimulator
Generic NameStimulator, bone growth, non-invasive
ApplicantOrthofix US LLC
3451 Plano Parkway
Lewisville, TX 75056
PMA NumberP210035
Date Received10/13/2021
Decision Date05/03/2022
Product Code LOF 
Docket Number 22M-0751
Notice Date 05/06/2022
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the AccelStim Ultrasound Bone Growth Stimulator, a non-invasive Low-Intensity Pulsed Ultrasound (LIPUS) device intended to aid fracture healing. The device is Rx only, and intended for single patient use in adult patients only.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S002 
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