Generator, Shock-wave, For Pain Relief

Device Code: 4731

Product Code(s): NBN

Device Classification Information

Device Type ID4731
Device NameGenerator, Shock-wave, For Pain Relief
Review PanelOrthopedic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Orthopedic Devices (DOD)
Joint And Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2)
Submission TypePMA
FDA Device ClassificationClass 3 Medical Device
Product CodeNBN
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4731
DeviceGenerator, Shock-wave, For Pain Relief
Product CodeNBN
FDA Device ClassificationClass 3 Medical Device
TPLC Last Update: 2019-04-02 20:54:38

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