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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namestimulator, ultrasound and muscle, for use other than applying therapeutic deep
Generic Namelow-intensity pulsed ultrasonic device for the treatment on nonunion
PMA NumberP900009
Supplement NumberS022
Date Received12/16/2005
Decision Date06/26/2006
Product Code
LPQ[ Registered Establishments with LPQ ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the modification of the existing exogen 2000+ and exogen 3000 low intensity ultrasound fracture treatment systems - sonic accelerated fracture healing system (safhs) to the exogen 4000+. The exogen 4000+ is modified to incorporate user-interface modifications and design modifications to compensate for changes in electronic component availability. The device, as modified, will be marketed under the trade name exogen 4000+ bone healing system. The exogen 4000+ is indicated for the non-invasive treatment of established non-unions excluding skull and vertebra. In addition, it is indicated for accelerating the time to a healed fracture, for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or grade i open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopaedically managed by closed reduction and cast immobilization.