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U.S. Department of Health and Human Services

Product Classification

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Device infant heel warmer (chemical heat pack)
Regulation Description Hot or cold disposable pack.
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeMPO
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 890.5710
Device Class 1
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
Third Party Review
Accredited Persons

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