[renewiltord]

I only just noticed that the wheelchair https://libertymemesfoundation.org/donations/endurance-the-o... is actually a Class 2 device. That sounds really hard to get past the FDA. I think it's pretty cool still because folks with the knowhow could make their own, but the disabled are probably SOL because you can't really make these for sale without that.

I suppose the FDA's reasoning is that they're better off having no mobility than having a device that doesn't work properly.

[HillRat]

Without commenting on the specific standards and regulations, the parade of horribles that could go wrong with a powered wheelchair is pretty extensive, when realizing that when a wheelchair goes wrong the user cannot move away from it. Consider the risks of a battery fire you can't escape, a drivetrain that could grab loose clothing around a pair of immobile legs, or a user whose wheelchair dies on an empty street at night at -10°F because it couldn't handle the cold for long enough. This doesn't mean the incumbents aren't fixing the regulations to ensure they've got a manufacturing moat -- this being healthcare, I assume that's exactly what they're doing -- but the FDA definitely has reasons to make sure these are regulated.

[zmgsabst]

Do they?

I don’t think the FDA is in a position to asses whether those risks versus the benefits of mobility are an appropriate trade off for any individual.

The FDA is deciding that some people should have no mobility so that others have… what, exactly?

The people who bought $65,000 chairs still could — and they’d be equally reliable. But because one person needs to use it in Alaska, all people need to pay a premium… even if they live somewhere that cold rating is completely irrelevant and adding a needless $5000-10000 to the price.

While there’s a reason to regulate for truth in advertising and basic safety, eg, not catching fire on its own, the actual regulations extend far beyond that into adjudicating personal risk management without clear benefit.

I’m not a fan of technocracy — I think people themselves know what’s best for them.

[harimau777]

Under that model, what about the people who can't afford a more reliable wheelchair because insurance is no longer obligated to cover it?

[wolverine876]

> I don’t think the FDA is in a position to asses whether those risks versus the benefits of mobility are an appropriate trade off for any individual.

Why wouldn't the FDA, which employs experts for that exact task, assess risks? Who is in a better position?

> I think people themselves know what’s best for them.

How can anyone but an expert evaluate the safety of a powered wheelchair?

[icegreentea2]

I don't think powered wheelchairs should be Class II, but we should be a bit kinder to the FDA.

The FDA is not comparing no mobility and simply an inoperable device, the FDA is comparing no mobility vs the possible outcomes of an malfunctioning device. Like perhaps what happens if the throttle gets stuck on forward.

[readyman]

The FDA serves many compromised purposes that, in sum, prioritize the interests of the capitalists who predominately control it. The same can be said for the entire US government.

[wolverine876]

Everyone keeps repeating it, but could you give evidence of that happening? Who are the commissioners? What about the staff?

[readyman]

The rich keep getting richer faster at the expense of everyone else.

[wolverine876]

That could have many causes. What evidence connects it to regulations? Usually, regulation limits excesses and can keep markets more open.

[throwaway173738]

I can assure you that the FDA does no such thing, as I have been through a very difficult 510k at a previous employer.