• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePHYSIO-STIM BONE GROWTH STIMULATOR
Classification Namestimulator, bone growth, non-invasive
Generic Namestimulator, bone growth, non-invasive
Applicant
Orthofix, Inc.
3451 plano parkway
lewisville, TX 75056
PMA NumberP850007
Supplement NumberS025
Date Received03/13/2000
Decision Date05/31/2000
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
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
-
-