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 Type ID | 3821 |
Device Name | Device, Discharge, Electrostatic (for Pain Relief) |
Regulation Description | Infrared Lamp. |
Regulation Medical Specialty | Physical Medicine |
Review Panel | Neurology |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB) |
Submission Type | 510(k) |
CFR Regulation Number | 890.5500 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | NHH |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 3821 |
Device | Device, Discharge, Electrostatic (for Pain Relief) |
Product Code | NHH |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Infrared Lamp. |
CFR Regulation Number | 890.5500 [🔎] |