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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16-225
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Standard | |
RESNA ANSI WC-1:2019 Section 26 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 26: Vocabulary |
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Scope/AbstractThis section of RESNA WC-1 specifies a vocabulary consisting of terms and definitions used in the field of manual and electrically powered wheelchairs (including scooters) and associated seating systems. This section of RESNA WC-1 includes, but is not limited to, the preferred terms used in two or more sections of the RESNA WC-1, WC-2, WC-3, and WC-4 standards, but does not include terms considered to be adequately defined in everyday English. |
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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)*
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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. |