| Device Type ID | 5059 |
| Device Name | Cable, Electrode |
| Regulation Description | Electrode Cable. |
| 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) Exempt |
| CFR Regulation Number | 890.1175 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | IKD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5059 |
| Device | Cable, Electrode |
| Product Code | IKD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electrode Cable. |
| CFR Regulation Number | 890.1175 [🔎] |
| Device Problems | |
|---|---|
Connection Problem | 55 |
Break | 11 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Device Operates Differently Than Expected | 3 |
Pacing Problem | 3 |
Failure To Deliver Energy | 2 |
Misconnection | 2 |
Device Displays Incorrect Message | 2 |
No Pacing | 1 |
Electrical /Electronic Property Problem | 1 |
Invalid Sensing | 1 |
Capturing Problem | 1 |
No Apparent Adverse Event | 1 |
High Sensing Threshold | 1 |
Failure To Capture | 1 |
Device Component Or Accessory | 1 |
Fracture | 1 |
Device Issue | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Low Sensing Threshold | 1 |
Disconnection | 1 |
Detachment Of Device Or Device Component | 1 |
| Total Device Problems | 96 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ad-Tech Medical Instrument Corporation | II | Apr-15-2016 |
| 2 | GE Healthcare, LLC | III | Mar-26-2019 |
| 3 | Oscor, Inc. | I | Apr-10-2017 |