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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, bone growth, non-invasive
Generic Namestimulator, bone growth, non-invasive
ApplicantDJO, LLC
PMA NumberP910066
Supplement NumberS024
Date Received10/12/2007
Decision Date12/10/2007
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee Physical Medicine
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the modification of the existing coil geometry, the addition of a wired control box, the reconfiguration of the patient padding system, and the removal of the infrared patient compliance component. The device, as modified, will be marketed under the trade name ol1000 dual coil medium bone growth stimulation device and is indicated for the non-invasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones.