| Device Type ID | 3638 |
| Device Name | Stimulator, Electrical, Evoked Response |
| Regulation Description | Evoked Response Electrical Stimulator. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.1870 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GWF |
| 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 | 3638 |
| Device | Stimulator, Electrical, Evoked Response |
| Product Code | GWF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Evoked Response Electrical Stimulator. |
| CFR Regulation Number | 882.1870 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CADWELL INDUSTRIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EB NEURO, S.P.A. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SAFEOP SURGICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 41 |
Use Of Device Problem | 19 |
Sensing Intermittently | 12 |
False Negative Result | 10 |
Mechanical Problem | 10 |
Adverse Event Without Identified Device Or Use Problem | 9 |
Inappropriate Shock | 8 |
Device Stops Intermittently | 7 |
Appropriate Term/Code Not Available | 6 |
Signal Artifact | 4 |
Connection Problem | 3 |
Circuit Failure | 3 |
Electrical /Electronic Property Problem | 3 |
Failure To Sense | 3 |
Computer Software Problem | 3 |
Loose Or Intermittent Connection | 3 |
Unable To Obtain Readings | 3 |
Impedance Problem | 2 |
Audible Prompt / Feedback | 2 |
Overheating Of Device | 2 |
Output Problem | 2 |
Insufficient Information | 2 |
Device Issue | 2 |
Patient Data Problem | 2 |
Defective Component | 2 |
Device Sensing Problem | 2 |
Device Displays Incorrect Message | 2 |
Failure To Calibrate | 2 |
Intermittent Continuity | 1 |
Application Program Freezes, Becomes Nonfunctional | 1 |
Device Inoperable | 1 |
Decoupling | 1 |
Energy Output Problem | 1 |
Fire | 1 |
Intermittent Program Or Algorithm Execution | 1 |
Application Program Problem | 1 |
Device Emits Odor | 1 |
Fitting Problem | 1 |
Device-Device Incompatibility | 1 |
Incomplete Or Inadequate Connection | 1 |
Noise, Audible | 1 |
Temperature Problem | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Break | 1 |
Display Or Visual Feedback Problem | 1 |
Failure To Analyze Signal | 1 |
| Total Device Problems | 187 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Natus Medical Incorporated | II | Feb-09-2015 |
| 2 | Nexstim PLC | II | May-22-2017 |
| 3 | Nihon Kohden America Inc | II | Feb-17-2016 |