Part 890 Subpart B—Physical Medicine Diagnostic Devices
FDA submissions for Part 890 Subpart B—Physical Medicine Diagnostic Devices in the Physical Medicine (PM) review panel, including product codes and regulations.
Section range: §§ 890.1175–890.1925
CFR Part: 890
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| IKD | Cable, Electrode | 890.1175 | 2 | 6 |
| IKP | Chronaximeter | 890.1225 | 2 | 0 |
| IKN | Electromyograph, Diagnostic | 890.1375 | 2 | 75 |
| KZM | Device, Muscle Monitoring | 890.1375 | 2 | 19 |
| OAL | Exercise Equipment, Powered, Emg-Triggered | 890.1375 | 2 | 1 |
| IKT | Electrode, Needle, Diagnostic Electromyograph | 890.1385 | 2 | 43 |
| IKO | Hammer, Reflex, Powered | 890.1450 | 2 | 1 |
| KHX | Platform, Force-Measuring | 890.1575 | 1 | 15 |
| JFC | System, Pressure Measurement, Intermittent | 890.1600 | 1 | 11 |
| IKE | Transducer, Miniature Pressure | 890.1615 | 1 | 15 |
| LYH | Arthrometer | 890.1615 | 1 | 5 |
| ISB | Stimulator, Muscle, Diagnostic | 890.1850 | 2 | 5 |
| IKK | System, Isokinetic Testing And Evaluation | 890.1925 | 2 | 61 |