| Device Type ID | 3818 |
| Device Name | Electromyograph, Diagnostic |
| Regulation Description | Diagnostic Electromyograph. |
| Regulation Medical Specialty | Physical Medicine |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 890.1375 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | IKN |
| 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 | 3818 |
| Device | Electromyograph, Diagnostic |
| Product Code | IKN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Diagnostic Electromyograph. |
| CFR Regulation Number | 890.1375 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CADWELL INDUSTRIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DORSA VI PTY. LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DORSAVI PTY LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NATUS MEDICAL INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 9 |
Device-Device Incompatibility | 7 |
Defibrillation Problem | 5 |
Device Operational Issue | 5 |
Appropriate Term/Code Not Available | 2 |
Use Of Device Problem | 1 |
Invalid Sensing | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Compatibility Problem | 1 |
Loose Or Intermittent Connection | 1 |
Unable To Obtain Readings | 1 |
Display Or Visual Feedback Problem | 1 |
Temperature Problem | 1 |
Sensing Intermittently | 1 |
| Total Device Problems | 37 |