电动轮椅是在传统手动轮椅的基础上，叠加高性能动力驱动装置、智能操纵装置、电池等部件，改造升级而成的。
具备人工操纵智能控制器，就能驱动轮椅完成前进、后退、转向、站立、平躺、等多种功能的新一代智能化轮椅，是现代精密机械、智能数控、工程力学等领域相结合的高新科技产品。
电动轮椅出口美国需要办理FDA 510(k)认证，下面详细来了解下电动轮椅FDA 510(k)认证办理。
FDA是食品和药物管理局（Food and DrugAdministration）的简称,被公认为是世界上*大的食品与药物管理机构之一。其职责是确保美国本国生产或进口的食品、化妆品、药物、生物制剂、医疗设备和放射产品的安全。出口到美国的食品，药品，医疗设备，化妆品等必须要注册了FDA才能顺利清关。
根据风险等级的不同，FDA将医疗器械分为三类（Ⅰ，Ⅱ，Ⅲ），Ⅲ类风险等级*高。
Ⅰ类医疗器械：一般管制
这些器材只要经过一般管制就可以确保其功效与安全性，如拐杖、眼镜片、胶布等，约占全部医疗器材的47%。
这些管制包括：禁止粗制滥造及不当标示的产品销售；FDA得禁止不合格产品销售；必须报告FDA有关危害性、修理、置换等事项；限制某些器材的贩卖、销售、及使用。
实施GMP:要求国内制造商、进口商及销售者都要向FDA注册，制造者须列明所制造的产品，Class II及ClassIII同样要遵守以上要求。
Ⅱ 类医疗器械：特别管制
这些产品尚须符合FDA所订定的特别要求或其它工业界公认的标准，此类产品包含医用手套、电动轮椅、助听器、血压计、诊疗导管等，约占所有器材的46%。FDA的特别要求之中，对特定产品另有强制性的标准(mandatoryperformance standards)、病患登记及上市后监督等。
Ⅲ 类医疗器械：上市前许可
这些产品多为维持、支持生命或植入体内的器材，对病患具有潜在危险，可能引起伤害或疾病，如心律调节器、子宫内器材及婴儿保温箱等，约占所有器材的7%。这些器材必须取得FDA的PMA之后方能销售。
FDA将每一种医疗器械都明确规定其产品分类和管理要求，FDA医疗器械产品目录中共有1700多种。任何一种医疗器械想要进入美国市场，必须弄清申请上市产品分类和管理要求。电动轮椅FDA注册属于医疗器械2类，需要办理FDA510(k)认证。
电动轮椅FDA510K申请企业需要提供什么资料？
申请510K涉及的产品相关资料：
器械名称及类别
指定用途声明
器械标签包装
零部件清单
与实质等同性器械的对比
电动轮椅510（K）认证流程：
第一步：根据产品以及FDA相关法规，指导原则制定510(k)申请信息清单。清单包含编写510(k)申请文件所需的所有材料及要求，例如：图纸，规格，原材料，测试项目及测试方案（如有）等。
第二步：根据客户提供的初步材料，例如说明书，产品手册等，及产品的特点选定对比产品。
第三步：准备测试样品。测试样品应当包含客户的申请产品以及选定的对比产品。
第四步：申请DUNS编号
第五步：测试准备工作，联系检测机构，获取报价，说明检测项目和检测要求等。
第六步：准备510(k)申请信息清单所列材料。
第七步：协助客户准备材料
第八步：产品测试，由实验室对产品进行测试。
第九步：编写510(k)文件，并向FDA递交文件
第十步：FDA受理行政审核
第十一步：FDA技术审核（第一次）
第十二步：FDA技术审核（交互）
第十三步、审核通过，获得K号
电动轮椅相关测试标准
· 16-25 ISO 7176-13First edition 1989-08-01
Wheelchairs - Part 13: Determination of coefficient of friction oftest surfaces
· 16-27 ISO 7176-15First edition 1996-11-15
Wheelchairs - Part 15: Requirements for information disclosure,documentation and labeling
· 16-162 ISO 7176-4Third edition 2008-10-01
Wheelchairs - Part 4: Energy consumption of electric wheelchairsand scooters for determination of theoretical distancerange
· 16-163 ISO 7176-5Second edition 2008-06-01
Wheelchairs - Part 5: Determination of overall dimensions, mass andmanoeuvring space
· 16-164 ISO 7176-10Second edition 2008-11-01
Wheelchairs - Part 10: Determination of obstacle-climbing abilityof electrically powered wheelchairs
· 16-165 ISO 7176-14Second edition 2008-02-15
Wheelchairs - Part 14: Power and control systems for electricallypowered wheelchairs and scooters - Requirements and testmethods
· 16-166 ISO 7176-21Second edition 2009-04-01
Wheelchairs - Part 21: Requirements and test methods forelectromagnetic compatibility of electrically powered wheelchairsand scooters, and battery chargers
· 16-167 ISO 7176-9Third edition 2009-11-15
Wheelchairs - Part 9: Climatic tests for electricwheelchairs
· 16-190 ISO 7176-11Second edition 2012-12-01
Wheelchairs - Part 11: Test dummies
· 16-191 ISO 7176-16Second edition 2012-12-01
Wheelchairs - Part 16: Resistance to ignition of postural supportdevices
· 16-192 ISO 7176-3Third edition 2012-12-15
Wheelchairs - Part 3: Determination of effectiveness ofbrakes
· 16-194 ISO 7176-25First edition 2013-07-15
Wheelchairs - Part 25: Batteries and chargers for poweredwheelchairs
· 16-195 ISO 7176-1Third edition 2014-10-01
Wheelchairs - Part 1: Determination of static stability
· 16-196 ISO 7176-7First Edition 1998-05-15
Wheelchairs - Part 7: Measurement of seating and wheeldimensions
· 16-197 ISO 7176-8Second editon 2014-12-15
Wheelchairs - Part 8: Requirements and test methods for static,impact and fatigue strengths
· 16-198 ISO 7176-22Second edition 2014-09-01
Wheelchairs - Part 22: Set-up procedures
· 16-201 ISO 7176-19Second Edition 2008-07-15
Wheelchairs Part 19: Wheeled mobility devices for use as seats inmotor vehicles [Including AMENDMENT 1 (2015)]
· 16-202 ISO 7176-2Third edition 2017-10
Wheelchairs - Part 2:Determination of dynamic stability ofelectrically powered wheelchairs
· 16-203 ASME A18.1-2017
Safety Standard for Platform Lifts and Stairway Chairlifts
· 16-204 ISO 7176-6Third edition 2018-06
Wheelchairs - Part 6: Determination of maximum speed, accelerationand deceleration of electric wheelchairs
· 16-206 ISO 7176- 30 First edition 2018-12
Wheelchairs --Part 30: Wheelchairs for changing occupant posture--Test methods and requirements
· 16-207 ANSI RESNA WC-1:2019p 1
American National Standard for Wheelchairs - Volume 1: Requirementsand Test Methods for Wheelchairs (including Scooters) p 1:Determination of static stability
· 16-208 ANSI RESNA WC-2:2019p 2
American National Standard for Wheelchairs - Volume 2: AdditionalRequirements for Wheelchairs (including Scooters) with ElectricalSystems p 2: Determination of dynamic stability of electricallypowered wheelchairs
· 16-209 ANSI RESNA WC-1:2019p 3
American National Standard for Wheelchairs - Volume 1: AdditionalRequirements for Wheelchairs (including Scooters) p 3:Determination of effectiveness of brakes
· 16-210 ANSI RESNA WC-2:2019p 4
American National Standard for Wheelchairs - Volume 2: AdditionalRequirements for Wheelchairs (including Scooters) with ElectricalSystems p 4: Energy consumption of electrically powered wheelchairsand scooters for determination of theoretical distancerange
· 16-211 ANSI RESNA WC-1:2019p 5
American National Standard for Wheelchairs - Volume 1: Requirementsand Test Methods for Wheelchairs (including Scooters) p 5:Determination of dimensions, mass and maneuvering space
· 16-212 ANSI RESNA WC-2:2019p 6
American National Standard for Wheelchairs - Volume 2: AdditionalRequirements for Wheelchairs (including Scooters) with ElectricalSystems p 6: Determination of maximum speed of electrically poweredwheelchairs.
· 16-213 ANSI RESNA WC-1:2019p 7
American National Standard for Wheelchairs - Volume 1: Requirementsand Test Methods for Wheelchairs (including Scooters) p 7: Methodof measurement of seating and wheel dimensions
· 16-214 ANSI RESNA WC-1:2019p 8
American National Standard for Wheelchairs - Volume 1: Requirementsand Test Methods for Wheelchairs (including Scooters) p 8:Requirements and test methods for static, Iipact and fatiguestrengths
· 16-215 ANSI RESNA WC-2:2019p 9
American National Standard for Wheelchairs - Volume 2: AdditionalRequirements for Wheelchairs (including Scooters) with ElectricalSystems p 9: Climatic tests for Eeectrically poweredwheelchairs
· 16-216 ANSI RESNA WC-2:2019p 10
American National Standard for Wheelchairs - Volume 2: AdditionalRequirements for Wheelchairs (including Scooters) with ElectricalSystems p 10: Determination of obstacle-climbing ability ofelectrically powered wheelchairs
· 16-217 ANSI RESNA WC-1:2019p 11
American National Standard for Wheelchairs - Volume 1: Requirementsand Test Methods for Wheelchairs (including Scooters) p 11: Testmannequins
· 16-218 ANSI RESNA WC-1:2019p 13
American National Standard for Wheelchairs - Volume 1: Requirementsand Test Methods for Wheelchairs (including Scooters) p 13:Determination of Coefficient of Friction of Test Surfaces
· 16-219 ANSI RESNA WC-2:2019p 14
American National Standard for Wheelchairs - Volume 2: AdditionalRequirements for Wheelchairs (including Scooters) with ElectricalSystems p 14: Power and Control Systems for Electrically PoweredWheelchairs Requirements and Test Methods
· 16-220 ANSI RESNA WC-1:2019p 15
American National Standard for Wheelchairs - Volume 1: Requirementsand Test Methods for Wheelchairs (including Scooters) p 15:Requirements for Information Disclosure, Documentation andLabeling
· 16-221 ANSI RESNA WC-1:2019p 16
American National Standard for Wheelchairs - Volume 1: Requirementsand Test Methods for Wheelchairs (including Scooters) p 16:Resistance to Ignition of Upholstered Parts - Requirements and TestMethods
· 16-223 ANSI RESNA WC-1:2019p 22
American National Standard for Wheelchairs - Volume 1: Requirementsand Test Methods for Wheels chairs (including Scooters) p 22:Set-up Procedures
· 16-224 ANSI RESNA WC-2:2019p 21
American National Standard for Wheelchairs - Volume 2, AdditionalRequirements for Wheelchairs (including Scooters) with ElectricalSystems p 21: Requirements and test methods for electromagneticcompatibility of electrically powered wheelchairs and motorizedscooters
· 16-225 ANSI RESNA WC-1:2019p 26
American National Standard for Wheelchairs - Volume 1: Requirementsand Test Methods for Wheelchairs (including Scooters) p 26:Vocabulary
· 16-230 ANSI RESNA WC-2:2019p 25
American National Standard for Wheelchairs - Volume 2: AdditionalRequirements for Wheelchairs (including Scooters) with ElectricalSystems p 25: Batteries and Chargers for PoweredWheelchairs
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