PMA P210035S003

Device: AccelStim
Applicant: Orthofix US, LLC
PMA number: P210035
Supplement: S003
Product code: LOF
Decision date: 2025-03-21
Classification: Orthopedic
Generic name: Stimulator, bone growth, non-invasive
Approval order statement: Approval for an updated "next generation/AccelStim 2.0" version of the AccelStim device to include modifications to the controller user interface, ergonomics, aesthetics, and the integration of Bluetooth data transfer for connectivity with the optional Stim onTrack mobile application. The Stim onTrack mobile application has also been updated to optionally incorporate activity tracker data.

Current openFDA PMA Record#

Device: AccelStim
Applicant: Orthofix US, LLC
PMA number: P210035
Supplement: S003
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 2025-03-21
Decision code: APPR
Date received: 2024-09-09
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for an updated "next generation/AccelStim 2.0" version of the AccelStim device to include modifications to the controller user interface, ergonomics, aesthetics, and the integration of Bluetooth data transfer for connectivity with the optional Stim onTrack mobile application. The Stim onTrack mobile application has also been updated to optionally incorporate activity tracker data.