AccelStim
FDA premarket approval P210035/S003 · decided 2025-03-21
Approval details
- PMA number
- P210035
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AccelStim
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Orthofix US, LLC
- Date received
- 2024-09-09
- Decision date
- 2025-03-21
- Days to decision
- 193 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lewisville, TX
- 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.
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| Firebird SI Navigation System (K252088) | Orthofix US, LLC | 2025-10-31 |
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