FDA.reportPublic FDA data

PMA P850007S038

Device
PhysioStim and SpinalStim
Applicant
Orthofix, Inc.
PMA number
P850007
Supplement
S038
Product code
LOF
Decision date
2018-03-07
Classification
Stimulator, Bone Growth, Non-invasive
Generic name
Stimulator, bone growth, non-invasive
Approval order statement
Approval for updates to the STIM onTrack mobile application for compatibility with Android OS. The optional mobile application is identical in functionality to the previously approved iOS version. The application is compatible with the CervicalStim Model 5505, SpinalStim Model 5212, and PhysioStim Models 5302, 5303, 5313, 5314, and 5315.

Current openFDA PMA Record#

Device
PhysioStim and SpinalStim
Applicant
Orthofix, Inc.
PMA number
P850007
Supplement
S038
Product code
LOF
Generic name
Stimulator, bone growth, non-invasive
Decision date
2018-03-07
Decision code
APPR
Date received
2017-12-07
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for updates to the STIM onTrack mobile application for compatibility with Android OS. The optional mobile application is identical in functionality to the previously approved iOS version. The application is compatible with the CervicalStim Model 5505, SpinalStim Model 5212, and PhysioStim Models 5302, 5303, 5313, 5314, and 5315.