| Device Type ID | 3819 |
| Device Name | Electrode, Needle, Diagnostic Electromyograph |
| Regulation Description | Diagnostic Electromyograph Needle Electrode. |
| 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 | 890.1385 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | IKT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 3819 |
| Device | Electrode, Needle, Diagnostic Electromyograph |
| Product Code | IKT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Diagnostic Electromyograph Needle Electrode. |
| CFR Regulation Number | 890.1385 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIO PROTECH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NATUS MEDICAL INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Material Separation | 26 |
Detachment Of Device Component | 5 |
Break | 4 |
Lead(s), Burn(s) From | 3 |
Bent | 3 |
Device Operational Issue | 1 |
Device Stops Intermittently | 1 |
Misassembled | 1 |
Contamination / Decontamination Problem | 1 |
Biocompatibility | 1 |
Material Deformation | 1 |
Out-Of-Box Failure | 1 |
Component Or Accessory Incompatibility | 1 |
False Negative Result | 1 |
| Total Device Problems | 50 |