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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 046 Date of Entry 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
§890.3890 Wheelchair, Stair Climbing Class 2 IMK
§890.3930 Elevator, Wheelchair, Portable Class 2 ING
§890.5150 Transport, Patient, Powered Class 2 ILK
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.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Kathryn Delaurentis
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Physical Medicine
*These are provided as examples and others may be applicable.