Product Classification

• Device: holder, infant position
• Regulation Description: Pediatric position holder.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: FRP
• Submission Type: 510(k)
• Regulation Number: 880.5680
• Device Class: 1
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: Yes

    Note: This device is also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.

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
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.