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U.S. Department of Health and Human Services

Product Classification

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Device lamp, infrared, therapeutic heating
Regulation Description Infrared lamp.
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeILY
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Physical Medicine and Neurotherapueutic Devices Branch (PNDB)
Submission Type 510(k)
Regulation Number 890.5500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons