| Device Type ID | 3685 |
| Device Name | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Regulation Description | Transcutaneous Electrical 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 | 882.5890 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GZJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 3685 |
| Device | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Product Code | GZJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Transcutaneous Electrical Nerve Stimulator For Pain Relief. |
| CFR Regulation Number | 882.5890 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AVAZZIA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOWAVE CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
DJ ORTHOPEDICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FUJI DYNAMICS LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MID-AMERICA MEDICAL INNOVATIONS, LLC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RELIEFBAND TECHNOLOGIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RITM OKB ZAO | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THRISOINT, PTY LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WELL-LIFE HEALTHCARE LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
XANACARE TECHNOLOGIES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
XAVANT TECHNOLOGY (PTY) LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 67 |
Temperature Problem | 8 |
Charred | 7 |
Device Issue | 4 |
Human Factors Issue | 3 |
Electrical /Electronic Property Problem | 3 |
Inappropriate Shock | 2 |
Electronic Property Issue | 2 |
Device Operational Issue | 2 |
Insufficient Information | 2 |
Mechanical Problem | 1 |
Overheating Of Device | 1 |
Output Problem | 1 |
Loose Or Intermittent Connection | 1 |
Material Protrusion / Extrusion | 1 |
Low Test Results | 1 |
Burst Container Or Vessel | 1 |
Device Operates Differently Than Expected | 1 |
Compatibility Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Circuit Failure | 1 |
Explosion | 1 |
Melted | 1 |
Physical Property Issue | 1 |
| Total Device Problems | 114 |