Device, Discharge, Electrostatic (for Pain Relief)

Device Code: 3821

Product Code(s): NHH

Definition: An Electrostatic Discharge Device Which Applies An Electrostatic Or Coronal Discharge To Or Near A Person's Skin For The Symptomatic Relief Of Pain

Device Classification Information

Device Type ID3821
Device NameDevice, Discharge, Electrostatic (for Pain Relief)
Regulation DescriptionInfrared Lamp.
Regulation Medical SpecialtyPhysical Medicine
Review PanelNeurology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Neurological And Physical Medicine Devices (DNPMD)
Physical Medicine And Rehabilitation Devices Branch (PMDB)
Submission Type510(k)
CFR Regulation Number890.5500 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeNHH
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3821
DeviceDevice, Discharge, Electrostatic (for Pain Relief)
Product CodeNHH
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionInfrared Lamp.
CFR Regulation Number890.5500 [🔎]
TPLC Last Update: 2019-04-02 20:37:32

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