| Device Type ID | 142 |
| Device Name | Stimulator, Nerve, Peripheral, Electric |
| Regulation Description | Electrical Peripheral Nerve Stimulator. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Anesthesiology Devices Branch (ANDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.2775 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KOI |
| 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 | 142 |
| Device | Stimulator, Nerve, Peripheral, Electric |
| Product Code | KOI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electrical Peripheral Nerve Stimulator. |
| CFR Regulation Number | 868.2775 [🔎] |
| Device Problems | |
|---|---|
Inappropriate Shock | 4 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Appropriate Term/Code Not Available | 1 |
Computer Operating System Problem | 1 |
Computer Software Problem | 1 |
| Total Device Problems | 8 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | GE Healthcare, LLC | II | May-21-2014 |