FDA Product Code ILK: Transport, Patient, Powered
A Powered Patient Transport Is A Motorized Device Intended For Use In Mitigating Mobility Impairment Caused By Injury Or Other Disease By Moving A Person From One Location Or Level To Another, Such As Up And Down Flights Of Stairs (e.g., Attendant-operated Portable Stair-climbing Chairs). This Generic Type Of Device Does Not Include Motorized Three-wheeled Vehicles Or Wheelchairs.
Leading manufacturers include Stryker Medical and Climbing Steps, Inc..
FDA 510(k) Cleared Transport, Patient, Powered Devices (Product Code ILK)
About Product Code ILK - Regulatory Context
510(k) Submission Activity
36 total 510(k) submissions under product code ILK since 1977, with 36 receiving FDA clearance (average review time: 78 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under ILK have taken an average of 194 days to reach a decision - up from 75 days historically. Manufacturers should account for longer review timelines in current project planning.
ILK devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →