PMA P850007S025

Device: PHYSIO-STIM BONE GROWTH STIMULATOR
Applicant: Orthofix, Inc.
PMA number: P850007
Supplement: S025
Product code: LOF
Decision date: 2000-05-31
Classification: Stimulator, Bone Growth, Non-invasive
Generic name: Stimulator, bone growth, non-invasive
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

Current openFDA PMA Record#

Device: PHYSIO-STIM BONE GROWTH STIMULATOR
Applicant: Orthofix, Inc.
PMA number: P850007
Supplement: S025
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 2000-05-31
Decision code: APPR
Date received: 2000-03-13
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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