Device Type ID | 5172 |
Device Name | Stimulator, Muscle, Diagnostic |
Regulation Description | Diagnostic Muscle Stimulator. |
Regulation Medical Specialty | Physical Medicine |
Review Panel | Physical Medicine |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB) |
Submission Type | 510(k) |
CFR Regulation Number | 890.1850 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | ISB |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
Device Type ID | 5172 |
Device | Stimulator, Muscle, Diagnostic |
Product Code | ISB |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Diagnostic Muscle Stimulator. |
CFR Regulation Number | 890.1850 [🔎] |