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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 046 Date of Recognition 12/23/2016 
FR Recognition Number 16-199
ISO 7176-28 First edition 2012-10-1
Wheelchairs Part 28: Requirements and test methods for stairclimbing devices
ISO 7176-28:2012 is applicable to stair-climbing chairs and stair-climbing wheelchair carriers where the stair-climbing device climbs backwards up the stairs, with the occupant facing downstairs, and climbs forwards down the stairs with the occupant also facing downstairs.

ISO 7176-28:2012 is applicable to stair-climbing devices which are intended for the transport of adults and those intended for the transport of children. It is not applicable to stair-climbing devices which are intended to be operated by children as operating occupants or assistants.

ISO 7176-28:2012 specifies requirements and test methods for electrically powered stair-climbing devices. It is not applicable to manually powered stair-climbing devices.

ISO 7176-28:2012 specifies tests to demonstrate the stair-climbing device's ability to perform safely on stairs with a pitch of 35°, or higher if declared by the manufacturer. It also includes ergonomic, labelling and disclosure requirements.

Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§890.5150 Transport, Patient, Powered Class 2 ILK
§890.3890 Wheelchair, Stair Climbing Class 2 IMK
§890.3930 Elevator, Wheelchair, Portable Class 2 ING
Relevant FDA Guidance and/or Supportive Publications
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles, Issued July 1995.
FDA Technical Contact
 Ian Marcus
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Physical Medicine