| Device Type ID | 38 |
| Device Name | Stimulator, Nerve, Battery-powered |
| 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 | BXN |
| 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 | 38 |
| Device | Stimulator, Nerve, Battery-powered |
| Product Code | BXN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electrical Peripheral Nerve Stimulator. |
| CFR Regulation Number | 868.2775 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
EASYMED INSTRUMENT CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HALYARD HEALTH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PAJUNK GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PAJUNK GMBH MEDIZINTECHNOLOGIE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
XAVANT TECHNOLOGY (PTY) LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Alarm System | 1 |
Failure To Shut Off | 1 |
Temperature Problem | 1 |
High Impedance | 1 |
| Total Device Problems | 4 |