Definition: Electrical Stimulation Unit With Leads And Cutaneous Electrodes Used To Apply An Electrical Current Through Electrodes On Patient's Skin To Provide Relief Of Pain Associated With Arthritis (including Osteoarthritis And Rheumatoid Arthritis).
| Device Type ID | 3756 |
| Device Name | Stimulator, Electrical, Transcutaneous, For Arthritis |
| Physical State | Electrical Stimulation Unit With Leads And Cutaneous Electrodes. |
| Technical Method | Applies An Electrical Current Through Electrodes On Patient's Skin. |
| Target Area | Over Or In Proximity To Affected Joint. |
| 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 | NYN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3756 |
| Device | Stimulator, Electrical, Transcutaneous, For Arthritis |
| Product Code | NYN |
| 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 | |
VISION QUEST INDUSTRIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |