斯特鲁特的电动轮椅不算轮椅(出于法律原因)
Strutt's Powered Wheelchair Is Not a Wheelchair (For Legal Reasons)

原始链接: https://www.core77.com/posts/145378

新加坡初创公司 Strutt 将其 ev¹ 推向市场时,将其称为“智能日常出行车辆”,而不是轮椅,从而避开了美国食品药品监督管理局(FDA)的医疗器械认证要求。 这款外形类似轮椅的车辆配备四个电动机、电子稳定控制系统、防抱死制动系统、操纵杆控制装置,以及用于避障和自主导航的摄像头和传感器。它能够攀爬 13 度的斜坡、越过 2 英寸高的路缘和 4.7 英寸宽的沟坎,还可在草地和碎石路面上行驶,并可配备车载储物空间。 不过,该车售价为 7,500 美元。由于未获得医疗器械认证,通常无法购买保险;其 640 瓦时的电池目前也未获准用于航空运输。Strutt 正在开发符合航空标准的电池。

Hacker News 上的一场讨论聚焦于 Strutt 设计的时尚电动椅。它采用类似摩托车车把的控制方式,能够攀爬陡坡、越过路缘,还能跨越较大的缺口。尽管功能亮眼,但由于电动轮椅被监管机构归类为医疗器械,因此这款椅子不能以轮椅的名义合法销售。 评论者对这种分类是否合理意见不一。支持者认为,医疗器械相关要求以及责任和保险规则能够保护使用者,但同时也会保护现有制造商、阻挡竞争,并阻碍创新产品进入市场。他们将这一情况与助听器通过非处方销售变得更便宜、更容易买到进行了比较。 另一些人则强调,轮椅在坡道上发生故障可能危及生命,因此他们质疑这款椅子的直立式设计及其无需操纵杆的控制方式是否带来了不可接受的风险。一位评论者指出,许多用户不喜欢操纵杆,更偏好车把式控制。讨论中还夹杂着一些讽刺:一些不安全的产品不依赖监管,而是靠用户评价、诉讼和市场声誉来约束。
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原文

Let's say you've assembled a team and designed an awesome powered wheelchair. One that works better than incumbent designs and is easy on the eyes.

How do you bring it to market? In the U.S., the process is onerous and regulation-ridden. Wheelchairs are considered Class II medical devices, like an infusion pump or an X-ray system. That means that you have to file tons of paperwork with the FDA proving that your design clears numerous hurdles.

Or you can do what Singaporean startup Strutt did: Just not label it a wheelchair and bring it to market, demonstrating what it can do. The Strutt ev¹ has four electric motors—one in each wheel—and features both electronic stability control and anti-lock brakes.

It is joystick-driven, but onboard cameras and sensors allow you to use Pathfinder and Waypoint modes, where it can avoid obstacles and self-drive to user-mapped points.

It can climb a 13° slope, clear a 2-inch curb and cross a 4.7-inch gap.

If you're heading down a steep slope, the powered wheels ease the descent.

Its wheels are also designed to drive over grass and gravel.

It can be fitted with onboard storage.

There are two potential downsides for wheelchair users. One is that insurance won't cover it, since it's not a certified medical device. Two is that its 640 Wh battery isn't cleared for air travel, so you can't fly with the chair. (The company says they're working on an airline-compliant battery.)

The ev¹ runs $7,500. You can learn more about it on the company's website, where they take pains to refer to it as a "smart everyday vehicle," rather than a wheelchair.

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