Product Classification

• Device: infant heel warmer (chemical heat pack)
• Regulation Description: Hot or cold disposable pack.
• Regulation Medical Specialty: Physical Medicine
• Review Panel: Physical Medicine
• Product Code: MPO
• Premarket Review: Office of Neurological and Physical Medicine Devices (OHT5); Neuromodulation and Physical Medicine Devices (DHT5B)
• Submission Type: 510(k)
• Regulation Number: 890.5710
• Device Class: 1
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Guidance Document

• Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc