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。

《The Hacker News》的一个讨论帖围绕 Strutt 的新型电动椅展开。这款椅子外形类似轮椅,但出于法律原因被宣传为“行动辅助设备”。尽管该帖被标记为广告,评论者主要讨论的是创新与医疗器械监管之间的矛盾。 支持者认为,安全审批至关重要,因为行动辅助设备一旦发生故障,可能危及生命;而监管负担也可能阻碍有前景的产品交付给用户。其他人则表示,客户目前已经可以直接购买这些创新椅子,而获得监管批准后,未来可能有助于获得更广泛的保险覆盖。 用户还讨论了现有电动椅的局限,尤其是摇杆控制方式,并表达了对车把式替代方案的兴趣。将这些产品与助听器进行比较,也引发了相关讨论:受监管的设备价格昂贵,但能提供个性化调适和编程服务,这是 AirPods 等产品所不具备的。另一个旁支讨论涉及“incumbent”一词 recently increasingly common in technology and business, alongside concerns about market consolidation《The Hacker News》的一个讨论帖围绕 Strutt 的新型电动椅展开。这款椅子外形类似轮椅,但出于法律原因被宣传为“行动辅助设备”。尽管该帖被标记为广告,评论者主要讨论的是创新与医疗器械监管之间的矛盾。 支持者认为,安全审批至关重要,因为行动辅助设备一旦发生故障,可能危及生命;而监管负担也可能阻碍有前景的产品交付给用户。其他人则表示,客户目前已经可以直接购买这些创新椅子,而获得监管批准后,未来可能有助于获得更广泛的保险覆盖。 用户还讨论了现有电动椅的局限,尤其是摇杆控制方式,并表达了对车把式替代方案的兴趣。将这些产品与助听器进行比较,也引发了相关讨论:受监管的设备价格昂贵,但能提供个性化调适和编程服务,这是 AirPods 等产品所不具备的。另一个旁支讨论涉及“incumbent”一词 recently increasingly common in technology and business, alongside concerns about market consolidation.
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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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