Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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053
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Date of Entry 12/23/2019
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FR Recognition Number
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16-222
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Standard | |
RESNA ANSI WC-1:2019 Section 20 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 20: Determination of the Performance of Stand-up Type Wheelchairs |
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Scope/AbstractThis section of RESNA WC-1 specifies test methods and requirements for determining the safety and performance of manual and powered wheelchairs that have a mode to assist the occupant to/and support the occupant while in the stand-up position. Included are wheelchairs that are stationary and those that are mobile while in the stand-up mode. This section of RESNA WC-1 is an addition to existing wheelchair standards, which apply to standup type wheelchairs when they are configured for the sit-down mode. Before testing a stand-up wheelchair in the stand-up configuration in accordance with this section of RESNA WC-1, the wheelchair shall first be tested in the sit-down configuration in accordance with the existing RESNA WC-1 wheelchair standards with modifications that are noted in this section of RESNA WC-1. |
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Extent of Recognition
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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. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§890.3900 |
Wheelchair, Standup
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Class 2
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IPL
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Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contact
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Standards Development Organizations
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |