External Upper Limb Tremor Stimulator

Device Code: 3806

Product Code(s): QBC

Definition: An External Upper Limb Tremor Stimulator Is A Prescription Device Which Is Placed Externally On The Upper Limb And Designed To Aid In Tremor Symptom Relief Of The Upper Limb.

Device Classification Information

Device Type ID3806
Device NameExternal Upper Limb Tremor Stimulator
Physical StateStimulator And Wrist Band
Technical MethodExternal Electrical Stimulator
Target AreaWrist
Regulation Medical SpecialtyNeurology
Review PanelNeurology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Neurological And Physical Medicine Devices (DNPMD)
Neurostimulation Devices Neurology Branch (NSDN)
Submission Type510(k)
CFR Regulation Number882.5897 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeQBC
GMP ExemptNo
Summary MRIneligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3806
DeviceExternal Upper Limb Tremor Stimulator
Product CodeQBC
FDA Device ClassificationClass 2 Medical Device
CFR Regulation Number882.5897 [🔎]
TPLC Last Update: 2019-04-02 20:37:14

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