Device Type ID | 4731 |
Device Name | Generator, Shock-wave, For Pain Relief |
Review Panel | Orthopedic |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2) |
Submission Type | PMA |
FDA Device Classification | Class 3 Medical Device |
Product Code | NBN |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4731 |
Device | Generator, Shock-wave, For Pain Relief |
Product Code | NBN |
FDA Device Classification | Class 3 Medical Device |