Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief

Device Code: 3762

Product Code(s): OCF

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 Classification Information

Device Type ID3762
Device NameStimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief
Physical StateElectrical Stimulation Unit With Leads And Cutaneous Electrodes.
Technical MethodApplies An Electrical Current Through Electrodes On A Patient's Skin.
Target AreaElectrodes Are Placed On The Skin To Stimulate Nerves In Proximity To The Painful Joint.
Regulation DescriptionTranscutaneous Electrical Nerve Stimulator For Pain Relief.
Regulation Medical SpecialtyNeurology
Review PanelNeurology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Neurological And Physical Medicine Devices (DNPMD)
Neurostimulation Devices Psychiatry Branch (NSDP)
Submission Type510(k)
CFR Regulation Number882.5890 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeOCF
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3762
DeviceStimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief
Product CodeOCF
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionTranscutaneous Electrical Nerve Stimulator For Pain Relief.
CFR Regulation Number882.5890 [🔎]
TPLC Last Update: 2019-04-02 20:36:09

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