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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 Namenon-invasive bone growth stimulator
PMA NumberP850022
Supplement NumberS012
Date Received07/09/1999
Decision Date07/26/1999
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for addition of a 3x5-inch package insert (to be used as a daily patient reminder of the key elements of orthopak unit maintenance) into the case of every shipped orthopak(r) unit. Each card contains the following information: bioelectron, inc. , 800-524-0677 call this number for batteries, electrodes, questions or billing inquiries. 1) change battery every morning. 2) change electrodes every 3-7 days or when they will not stick to your skin. Make sure yoru skin is clean and dry before applying new electrodes.