| Device Type ID | 4710 |
| Device Name | Stimulator, Bone Growth, Non-invasive |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | LOF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4710 |
| Device | Stimulator, Bone Growth, Non-invasive |
| Product Code | LOF |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Patient-Device Incompatibility | 50 |
Adverse Event Without Identified Device Or Use Problem | 46 |
Biocompatibility | 13 |
Insufficient Information | 13 |
Overheating Of Device | 2 |
Off-Label Use | 1 |
Use Of Device Problem | 1 |
No Apparent Adverse Event | 1 |
Appropriate Term/Code Not Available | 1 |
Sparking | 1 |
Inappropriate Shock | 1 |
| Total Device Problems | 130 |