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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 NamePHYSIO-STIM BONE GROWTH STIMULATOR
Classification Namestimulator, bone growth, non-invasive
Generic Namenon-invasive bone growth stimulator
ApplicantORTHOFIX, INC.
PMA NumberP850007
Supplement NumberS025
Date Received03/13/2000
Decision Date05/31/2000
Product Code
LOF
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 to modify the physio-stim, model 7215 as follows: 1. Combine the transducer and control units into a single unit; 2. Power the device with one 9-volt disposable battery rather than a multiple cell ni-cad battery pack with charger unit; 3. Based on the above changes, reduce the weight and overall dimensions of the device; 4. Indicate the operating status of the device with three led signal lights rather than an lcd readout; and 5. Control power to the device with an on/off button rather.
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