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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.
 
Trade NameORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR
Classification Namestimulator, bone growth, non-invasive
Generic Namebone growth stimulator
ApplicantORTHOLOGIC CORP.
PMA NumberP910066
Supplement NumberS005
Date Received02/26/1997
Decision Date05/09/1997
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee Physical Medicine
Supplement Typereal-time process
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of in vitro, and in vivo data from studies investigating the biological effects of combined magnetic fields on bone healing at the cellular level.
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