| Device Type ID | 3683 |
| Device Name | Stimulator, Peripheral Nerve, Implanted (pain Relief) |
| Regulation Description | Implanted Peripheral Nerve Stimulator For Pain Relief. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurostimulation Devices Psychiatry Branch (NSDP) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.5870 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GZF |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3683 |
| Device | Stimulator, Peripheral Nerve, Implanted (pain Relief) |
| Product Code | GZF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Implanted Peripheral Nerve Stimulator For Pain Relief. |
| CFR Regulation Number | 882.5870 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIONESS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STIMQ LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 636 |
Device Operates Differently Than Expected | 169 |
Impedance Problem | 64 |
High Impedance | 63 |
Migration Or Expulsion Of Device | 23 |
Fracture | 13 |
Therapy Delivered To Incorrect Body Area | 12 |
Break | 6 |
Inappropriate Shock | 5 |
Low Impedance | 4 |
Self-Activation Or Keying | 4 |
Temperature Problem | 4 |
Insufficient Information | 3 |
No Device Output | 3 |
Disconnection | 2 |
Malposition Of Device | 2 |
Unintended Movement | 2 |
Failure To Deliver Energy | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Communication Or Transmission Problem | 2 |
Unauthorized Access To Computer System | 1 |
Premature Discharge Of Battery | 1 |
Failure To Charge | 1 |
Use Of Device Problem | 1 |
Off-Label Use | 1 |
Patient Device Interaction Problem | 1 |
Difficult To Advance | 1 |
Low Battery | 1 |
| Total Device Problems | 1029 |