电动轮椅进入美国消费者市场必须提供FDA 510(K)，否则无法清关

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*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 p 1
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) p 1: Determination of static stability

·        16-208 ANSI RESNA WC-2:2019 p 2
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems p 2: Determination of dynamic stability of electrically powered wheelchairs

·        16-209 ANSI RESNA WC-1:2019 p 3
American National Standard for Wheelchairs - Volume 1: Additional Requirements for Wheelchairs (including Scooters) p 3: Determination of effectiveness of brakes

·        16-210 ANSI RESNA WC-2:2019 p 4
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems p 4: Energy consumption of electrically powered wheelchairs and scooters for determination of theoretical distance range

·        16-211 ANSI RESNA WC-1:2019 p 5
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) p 5: Determination of dimensions, mass and maneuvering space

·        16-212 ANSI RESNA WC-2:2019 p 6
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems p 6: Determination of maximum speed of electrically powered wheelchairs.

·        16-213 ANSI RESNA WC-1:2019 p 7
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) p 7: Method of measurement of seating and wheel dimensions

·        16-214 ANSI RESNA WC-1:2019 p 8
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) p 8: Requirements and test methods for static, Iipact and fatigue strengths

·        16-215 ANSI RESNA WC-2:2019 p 9
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems p 9: Climatic tests for Eeectrically powered wheelchairs

·        16-216 ANSI RESNA WC-2:2019 p 10
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems p 10: Determination of obstacle-climbing ability of electrically powered wheelchairs

·        16-217 ANSI RESNA WC-1:2019 p 11
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) p 11: Test mannequins

·        16-218 ANSI RESNA WC-1:2019 p 13
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) p 13: Determination of Coefficient of Friction of Test Surfaces

·        16-219 ANSI RESNA WC-2:2019 p 14
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems p 14: Power and Control Systems for Electrically Powered Wheelchairs Requirements and Test Methods

·        16-220 ANSI RESNA WC-1:2019 p 15
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) p 15: Requirements for Information Disclosure, Documentation and Labeling

·        16-221 ANSI RESNA WC-1:2019 p 16
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) p 16: Resistance to Ignition of Upholstered Parts - Requirements and Test Methods

·        16-223 ANSI RESNA WC-1:2019 p 22
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheels chairs (including Scooters) p 22: Set-up Procedures

·        16-224 ANSI RESNA WC-2:2019 p 21
American National Standard for Wheelchairs - Volume 2, Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems p 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters

·        16-225 ANSI RESNA WC-1:2019 p 26
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) p 26: Vocabulary

·        16-230 ANSI RESNA WC-2:2019 p 25
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems p 25: Batteries and Chargers for Powered Wheelchairs

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