| Device Type ID | 3675 |
| Device Name | Media, Electroconductive |
| Regulation Description | Electroconductive Media. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| 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 | 882.1275 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GYB |
| 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 | 3675 |
| Device | Media, Electroconductive |
| Product Code | GYB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electroconductive Media. |
| CFR Regulation Number | 882.1275 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CAROL COLE COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 3 |
Use Of Device Problem | 2 |
Appropriate Term/Code Not Available | 2 |
Electrical /Electronic Property Problem | 1 |
Device Operates Differently Than Expected | 1 |
Adhesive | 1 |
Patient Device Interaction Problem | 1 |
Failure To Conduct | 1 |
| Total Device Problems | 12 |