PMA P850007S037

Device: Physio-Stim
Applicant: Orthofix, Inc.
PMA number: P850007
Supplement: S037
Product code: LOF
Decision date: 2017-10-31
Classification: Stimulator, Bone Growth, Non-invasive
Generic name: Stimulator, bone growth, non-invasive
Approval order statement: approval for design modifications to garment, control unit housing, liquid crystal display (LCD), battery, printed circuit assembly, power supply, firmware, and mobile application to the Physio-Stim non-invasive bone growth stimulator devices. Labeling was updated to reflect design changes.

Current openFDA PMA Record#

Device: Physio-Stim
Applicant: Orthofix, Inc.
PMA number: P850007
Supplement: S037
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 2017-10-31
Decision code: APPR
Date received: 2017-08-15
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for design modifications to garment, control unit housing, liquid crystal display (LCD), battery, printed circuit assembly, power supply, firmware, and mobile application to the Physio-Stim non-invasive bone growth stimulator devices. Labeling was updated to reflect design changes.