Product Classification

• Device: transport, patient, powered
• Regulation Description: Powered patient transport.
• Regulation Medical Specialty: Physical Medicine
• Review Panel: Physical Medicine
• Product Code: ILK
• Premarket Review: Office of Neurological and Physical Medicine Devices (OHT5); Neuromodulation and Physical Medicine Devices (DHT5B)
• Submission Type: 510(k)
• Regulation Number: 890.5150
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 16-199 ISO 7176-28 First edition 2012-10-1
  Wheelchairs Part 28: Requirements and test methods for stairclimbing devices
• 16-203 ASME A18.1-2017
  Safety Standard for Platform Lifts and Stairway Chairlifts

Guidance Document

• Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment - Guidance for Industry and FDA Staff

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc