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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 Namestimulator, ultrasound and muscle, for use other than applying therapeutic deep
4721 emperor blvd suite 100
durham, NC 27703
PMA NumberP900009
Supplement NumberS022
Date Received12/16/2005
Decision Date06/26/2006
Product Code
LPQ[ Registered Establishments with LPQ ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
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.