Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
Basic Information
- Device Name
- Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
- Trade Name
- EXOGEN 4000+ BONE HEALING SYSTEM
- PMA Number
- P900009
- Supplement Number
- S022
- Device Class
- FDA Class 3
- Product Code
- LPQ
- Generic Name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- June 26, 2006
- Date Received
- December 16, 2005
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE MODIFICATION OF THE EXISTING EXOGEN 2000+ AND EXOGEN 3000 LOW INTENSITY ULTRASOUND FRACTURE TREATMENT SYSTEMS - SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) TO THE EXOGEN 4000+. THE EXOGEN 4000+ IS MODIFIED TO INCORPORATE USER-INTERFACE MODIFICATIONS AND DESIGN MODIFICATIONS TO COMPENSATE FOR CHANGES IN ELECTRONIC COMPONENT AVAILABILITY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EXOGEN 4000+ BONE HEALING SYSTEM. THE EXOGEN 4000+ IS INDICATED FOR THE NON-INVASIVE TREATMENT OF ESTABLISHED NON-UNIONS EXCLUDING SKULL AND VERTEBRA. IN ADDITION, IT IS INDICATED FOR ACCELERATING THE TIME TO A HEALED FRACTURE, FOR FRESH, CLOSED, POSTERIORLY DISPLACED DISTAL RADIUS FRACTURES AND FRESH, CLOSED OR GRADE I OPEN TIBIAL DIAPHYSIS FRACTURES IN SKELETALLY MATURE INDIVIDUALS WHEN THESE FRACTURES ARE ORTHOPAEDICALLY MANAGED BY CLOSED REDUCTION AND CAST IMMOBILIZATION.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LPQ | Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep | FDA class 3 | Unknown |