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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 052 Date of Recognition 07/15/2019 
FR Recognition Number 16-206
Standard
ISO 7176 - 30 First edition 2018-12
Wheelchairs --Part 30: Wheelchairs for changing occupant posture --Test methods and requirements
Scope/Abstract
This document specifies the test methods and requirements for determining the safety and performance of a manual and/or power wheelchair that incorporates technology to alter the posture of the wheelchair occupant, which are either electrically or manually operated by the occupant or assistant during normal wheelchair use. This can include recline, tilt, elevate and stand-up mechanisms or a combination of these. In order for a wheelchair to be able to recline, tilt, elevate and/or stand-up, the wheelchair requires additional mechanisms and mechanical structures to allow these features to operate. This document specifies the different functional and strength tests required to test these wheelchairs in critical configurations of their adjustable range.

This document does not cover wheelchairs where the only operator adjustable body support system (OABSS) is adjustable limb or head postural support devices alone (e.g. elevating leg supports).

This document does not include wheelchair and postural support device customization during initial or subsequent setup of a wheelchair for an individual occupant. It also does not reflect other factors that can influence wheelchair stability such as occupant movement, cushion thickness, and the addition of ancillary equipment (e.g. respiratory support items).

Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

NOTE: For questions regarding the testing positions, the manufacturer should contact the review team to address testing positions prior to submission.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§890.3800 Vehicle, Motorized 3-Wheeled Class 2 INI
§890.3850 Wheelchair, Mechanical Class 1 IOR
§890.3860 Wheelchair, Powered Class 2 ITI
§890.3880 Wheelchair, Special Grade Class 2 IQC
§890.3890 Wheelchair, Stair Climbing Class 2 IMK
§890.3900 Wheelchair, Standup Class 2 IPL
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.
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Physical Medicine
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