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
• 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

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• dekra certification b.v.
• intertek testing services
• pharmalink technical group, llc
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.