Product Classification

• Device: device, warning, overload, external limb, powered
• Regulation Description: Powered external limb overload warning device.
• Regulation Medical Specialty: Physical Medicine
• Review Panel: Physical Medicine
• Product Code: IRN
• Submission Type: 510(k)
• Regulation Number: 890.5575
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.