Thermal System For Insomnia

Device Code: 3788

Product Code(s): PLU

Definition: A Thermal System For Insomnia Is A Prescription Device For Use In Patients With Insomnia That Is Used To Apply A Specified Temperature To The Skin Surface.

Device Classification Information

Device Type ID3788
Device NameThermal System For Insomnia
Physical StateApplies A Specified Temperature To The Skin Surface In Patients With Insomnia.
Technical MethodApplies A Specified Temperature To The Skin Surface In Patients With Insomnia.
Target AreaSkin Surface.
Regulation DescriptionThermal System For Insomnia.
Regulation Medical SpecialtyNeurology
Review PanelNeurology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Neurological And Physical Medicine Devices (DNPMD)
Neurodiagnostic And Neurosurgical Devices Branch (NDNB)
Submission Type510(k)
CFR Regulation Number882.5700 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodePLU
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3788
DeviceThermal System For Insomnia
Product CodePLU
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionThermal System For Insomnia.
CFR Regulation Number882.5700 [🔎]
TPLC Last Update: 2019-04-02 20:36:55

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