Definition: Electrical Stimulation Of Nerves For Relief Of Pain Associated With Arthritis (including Osteoarthritis And Rheumatoid Arthritis). Relief Of Pain Associated With Arthritis (including Osteoarthritis And Rheumatoid Arthritis).
Device Type ID | 3762 |
Device Name | Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief |
Physical State | Electrical Stimulation Unit With Leads And Cutaneous Electrodes. |
Technical Method | Applies An Electrical Current Through Electrodes On A Patient's Skin. |
Target Area | Electrodes Are Placed On The Skin To Stimulate Nerves In Proximity To The Painful 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 | OCF |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 3762 |
Device | Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief |
Product Code | OCF |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Transcutaneous Electrical Nerve Stimulator For Pain Relief. |
CFR Regulation Number | 882.5890 [🔎] |