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 Drug Administration）的简称,被公认为是世界上最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类风险等级最高。
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Class III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(mandatory performance 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，必须首先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FDA 510(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 7176-13
First edition 1989-08-01
Wheelchairs -
Part 13: Determination of coefficient of friction of test surfaces
· 16-27 ISO 7176-15
First edition 1996-11-15
Wheelchairs -
Part 15: Requirements for information disclosure, documentation and labeling
· 16-162 ISO 7176-4
Third edition 2008-10-01
Wheelchairs -
Part 4: Energy consumption of electric wheelchairs and scooters for
determination of theoretical distance range
· 16-163 ISO 7176-5
Second edition 2008-06-01
Wheelchairs -
Part 5: Determination of overall dimensions, mass and manoeuvring space
· 16-164 ISO 7176-10
Second edition 2008-11-01
Wheelchairs -
Part 10: Determination of obstacle-climbing ability of electrically powered
wheelchairs
· 16-165 ISO 7176-14
Second edition 2008-02-15
Wheelchairs -
Part 14: Power and control systems for electrically powered wheelchairs and
scooters - Requirements and test methods
· 16-166 ISO 7176-21
Second edition 2009-04-01
Wheelchairs -
Part 21: Requirements and test methods for electromagnetic compatibility of
electrically powered wheelchairs and scooters, and battery chargers
· 16-167 ISO 7176-9
Third edition 2009-11-15
Wheelchairs -
Part 9: Climatic tests for electric wheelchairs
· 16-190 ISO 7176-11
Second edition 2012-12-01
Wheelchairs -
Part 11: Test dummies
· 16-191 ISO 7176-16
Second edition 2012-12-01
Wheelchairs -
Part 16: Resistance to ignition of postural support devices
· 16-192 ISO 7176-3
Third edition 2012-12-15
Wheelchairs -
Part 3: Determination of effectiveness of brakes
· 16-194 ISO 7176-25
First edition 2013-07-15
Wheelchairs -
Part 25: Batteries and chargers for powered wheelchairs
· 16-195 ISO 7176-1
Third edition 2014-10-01
Wheelchairs -
Part 1: Determination of static stability
· 16-196 ISO 7176-7
First Edition 1998-05-15
Wheelchairs -
Part 7: Measurement of seating and wheel dimensions
· 16-197 ISO 7176-8
Second editon 2014-12-15
Wheelchairs -
Part 8: Requirements and test methods for static, impact and fatigue strengths
· 16-198 ISO 7176-22
Second edition 2014-09-01
Wheelchairs -
Part 22: Set-up procedures
· 16-201 ISO 7176-19
Second Edition 2008-07-15
Wheelchairs
Part 19: Wheeled mobility devices for use as seats in motor vehicles [Including
AMENDMENT 1 (2015)]
· 16-202 ISO 7176-2
Third edition 2017-10
Wheelchairs -
Part 2:Determination of dynamic stability of electrically powered wheelchairs
· 16-203 ASME A18.1-2017
Safety
Standard for Platform Lifts and Stairway Chairlifts
· 16-204 ISO 7176-6
Third edition 2018-06
Wheelchairs -
Part 6: Determination of maximum speed, acceleration and 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-1:2019
Section 1
American
National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for
Wheelchairs (including Scooters) Section 1: Determination of static stability
· 16-208 ANSI RESNA WC-2:2019
Section 2
American
National Standard for Wheelchairs - Volume 2: Additional Requirements for
Wheelchairs (including Scooters) with Electrical Systems Section 2:
Determination of dynamic stability of electrically powered wheelchairs
· 16-209 ANSI RESNA WC-1:2019
Section 3
American
National Standard for Wheelchairs - Volume 1: Additional Requirements for
Wheelchairs (including Scooters) Section 3: Determination of effectiveness of
brakes
· 16-210 ANSI RESNA WC-2:2019
Section 4
American
National Standard for Wheelchairs - Volume 2: Additional Requirements for
Wheelchairs (including Scooters) with Electrical Systems Section 4: Energy
consumption of electrically powered wheelchairs and scooters for determination
of theoretical distance range
· 16-211 ANSI RESNA WC-1:2019
Section 5
American
National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for
Wheelchairs (including Scooters) Section 5: Determination of dimensions, mass
and maneuvering space
· 16-212 ANSI RESNA WC-2:2019
Section 6
American
National Standard for Wheelchairs - Volume 2: Additional Requirements for
Wheelchairs (including Scooters) with Electrical Systems Section 6:
Determination of maximum speed of electrically powered wheelchairs.
· 16-213 ANSI RESNA WC-1:2019
Section 7
American
National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for
Wheelchairs (including Scooters) Section 7: Method of measurement of seating
and wheel dimensions
· 16-214 ANSI RESNA WC-1:2019
Section 8
American
National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for
Wheelchairs (including Scooters) Section 8: Requirements and test methods for
static, Iipact and fatigue strengths
· 16-215 ANSI RESNA WC-2:2019
Section 9
American
National Standard for Wheelchairs - Volume 2: Additional Requirements for
Wheelchairs (including Scooters) with Electrical Systems Section 9: Climatic
tests for Eeectrically powered wheelchairs
· 16-216 ANSI RESNA WC-2:2019
Section 10
American
National Standard for Wheelchairs - Volume 2: Additional Requirements for
Wheelchairs (including Scooters) with Electrical Systems Section 10:
Determination of obstacle-climbing ability of electrically powered wheelchairs
· 16-217 ANSI RESNA WC-1:2019
Section 11
American
National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for
Wheelchairs (including Scooters) Section 11: Test mannequins
· 16-218 ANSI RESNA WC-1:2019
Section 13
American
National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for
Wheelchairs (including Scooters) Section 13: Determination of Coefficient of
Friction of Test Surfaces
· 16-219 ANSI RESNA WC-2:2019
Section 14
American
National Standard for Wheelchairs - Volume 2: Additional Requirements for
Wheelchairs (including Scooters) with Electrical Systems Section 14: Power and
Control Systems for Electrically Powered Wheelchairs Requirements and Test
Methods
· 16-220 ANSI RESNA WC-1:2019
Section 15
American
National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for
Wheelchairs (including Scooters) Section 15: Requirements for Information
Disclosure, Documentation and Labeling
· 16-221 ANSI RESNA WC-1:2019
Section 16
American
National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for
Wheelchairs (including Scooters) Section 16: Resistance to Ignition of
Upholstered Parts - Requirements and Test Methods
· 16-223 ANSI RESNA WC-1:2019
Section 22
American
National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for
Wheels chairs (including Scooters) Section 22: Set-up Procedures
· 16-224 ANSI RESNA WC-2:2019
Section 21
American
National Standard for Wheelchairs - Volume 2, Additional Requirements for
Wheelchairs (including Scooters) with Electrical Systems Section 21:
Requirements and test methods for electromagnetic compatibility of electrically
powered wheelchairs and motorized scooters
· 16-225 ANSI RESNA WC-1:2019
Section 26
American
National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for
Wheelchairs (including Scooters) Section 26: Vocabulary
· 16-230 ANSI RESNA WC-2:2019
Section 25
American
National Standard for Wheelchairs - Volume 2: Additional Requirements for
Wheelchairs (including Scooters) with Electrical Systems Section 25: Batteries
and Chargers for Powered Wheelchairs
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