Strutt's Powered Wheelchair Is Not a Wheelchair (For Legal Reasons)
Singaporean startup Strutt avoided the FDA's Class II medical device approval process by not labeling its ev¹ as a wheelchair. The four-motor vehicle features electronic stability control, anti-lock brakes, and self-driving modes, and can climb a 13° slope, clear a 2-inch curb, and cross a 4.7-inch gap. It costs $7,500, but insurance won't cover it and its 640 Wh battery isn't cleared for air travel.
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.
- probably_wrong
Leaving aside for a second that this post is clearly an ad.
There are reasons why you can't just say "here's a new wheelchair, have fun suckers!" and that's because a medical device is major part of someone's life and disruptions that would annoy healthy people can be life threatening to them. Worst case scenario you end up in a Second-Sight situation [1].
Let's take a random example: the page says "If you're heading down a steep slope, the powered wheels ease the descent". When the brakes of my bike suddenly stopped working on a steep slope I could just throw myself to the side and brake with my legs. If you're a using this "mobility device" as a wheelchair and this happens to you well, tough luck. You should have bought a wheelchair instead.
- chris_st
As a resident of an independent living facility, I live among a lot of people who use various makes and models of powered chairs. And a great many who have the joystick dislike it immensely, and would prefer to have the handlebars-style navigation. But it's kind of the only way to have the "chair" style, nothing in front of you design. Some of the more scooter-style have rotating chairs, so you can park parallel to a table and turn, but that depends on lower limb mobility, so no easy solutions here.
The "climb a 13° slope, clear a 2-inch curb and cross a 4.7-inch gap" is quite impressive.
- Legend2440
Reminds me of the situation with hearing aids. They're not particularly complicated devices compared to, say, $130 apple airpods. But because they were regulated as medical devices they often cost $3000 or more.
This has changed somewhat since 2022 now that they allow OTC hearing aids, although I believe they're still more expensive than airpods.