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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 Namebone growth stimulator
PMA NumberP900009
Supplement NumberS002
Date Received12/15/1995
Decision Date04/02/1996
Product Code
LPQ[ Registered Establishments with LPQ ]
Advisory Committee Physical Medicine
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new manufacturing facility which is owned and operated by hi-tronics designs, inc. And located at 999 willow grove st. , building 2, suites 4a, 4b and 18e, hackettstown, nj 07840. The safhs model 2a will be manufactured at this site.