Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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034
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Date of Entry 01/30/2014
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FR Recognition Number
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16-162
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Standard | |
ISO 7176-4 Third edition 2008-10-01 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range |
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Scope/AbstractISO 7176-4:2008 specifies methods for determining theoretical distance range of electrically powered wheelchairs, including scooters, using measurements of energy consumed while driving and the nominal energy capacity of the wheelchair's battery set. It is applicable to electrically powered wheelchairs with a maximum nominal speed no greater than 15 km/h, intended to provide indoor and/or outdoor mobility for one disabled person whose mass is within the range represented by ISO 7176-11. ISO 7176-4:2008 also includes requirements for test reports and information disclosure. |
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Extent of Recognition
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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 Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |