• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device device, discharge, electrostatic (for pain relief)
Regulation Description Infrared lamp.
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
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeNHH
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)
Regulation Number 890.5500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
-
-