Why Strutt's Electric Wheelchair Refuses to Call Itself a Wheelchair: The Product Design Logic Behind Regulations

A Product Redefined by Regulation

Strutt's electric wheelchair has sparked an interesting conversation: a device that looks like a wheelchair and functions like a wheelchair, yet officially insists it is not a "wheelchair." The reason is straightforward — it comes down to legal considerations. This reflects a long-standing regulatory dilemma in the assistive mobility industry, and the difficult balance startups must strike between compliance and innovation.

When a product is formally classified as a "medical device" or "wheelchair," it must navigate a comprehensive certification process, safety standards, and liability definitions. For startups, this means steep costs, lengthy approval timelines, and significant legal exposure. So "it's not a wheelchair" becomes a pragmatic product positioning strategy.

How Regulatory Classification Shapes Product Form

In many countries and regions, wheelchairs — especially electric ones — fall under the medical device category and are subject to specialized regulations. These cover product safety, reliability, and usage environment restrictions (such as indoor/outdoor use and road access rights). Once a product is classified as a medical device, manufacturers must fulfill corresponding compliance obligations and product liability requirements.

By defining the product as a "non-wheelchair" personal mobility device or mobility aid, manufacturers can, to a certain extent, sidestep the rigorous medical device regulatory pathway and bring their product to market faster. This "art of naming" is not uncommon in tech products — similar dynamics have played out in regulatory discussions around electric scooters, hoverboards, and other personal mobility devices.

Take the United States as an example: the FDA classifies power wheelchairs as Class II medical devices, requiring manufacturers to go through the 510(k) premarket notification process to demonstrate "substantial equivalence" to a legally marketed predicate device. The entire process can take months to years and cost anywhere from tens of thousands to hundreds of thousands of dollars. The EU, under MDR (Medical Device Regulation 2017/745), manages wheelchairs through a tiered classification system, requiring manufacturers to complete CE certification and establish a full post-market surveillance system. By contrast, products classified as "Personal Mobility Devices" currently face no unified specialized regulatory standard in most regions — they generally only need to meet general consumer product safety requirements to reach market. This enormous gap in regulatory thresholds is the fundamental driver behind manufacturers' carefully crafted naming strategies.

The Tension Between Innovation and Compliance

This case reveals a deeper industry issue: existing regulatory frameworks often lag behind the pace of technological innovation. As new mobility devices continue to emerge, classification systems remain anchored to the definitions of traditional products, forcing manufacturers to "push the boundaries" in product naming and positioning.

On the positive side, this flexibility allows innovative products to reach users who genuinely need them more quickly. But from a risk perspective, ambiguous classification can also create problems — unclear liability, insufficient user protections, and more. For instance, if a device is not recognized as a wheelchair, users may be unable to access related health insurance reimbursements or public facility access rights.

Real-World Impact from the User's Perspective

For end users, the product's name may not matter much — what matters is whether it solves their mobility needs. But differences in "legal identity" can directly affect the user experience: whether it can be used on sidewalks, whether it qualifies for insurance coverage, and how after-sale liability is defined — all of these are closely tied to the product's legal classification.

Discussion of this topic on Hacker News was modest in scale, but it reflects the tech community's ongoing interest in the intersection of regulation and product design. How to drive innovation while protecting user rights is a challenge the entire industry must collectively address.

Insurance reimbursement is where users feel the most direct impact. In the United States, Medicare Part B can cover qualifying power wheelchairs (referred to as Power Wheelchairs or Motorized Scooters), but only if the product has an HCPCS code and a physician provides a "medical necessity" certification. Once a device is reclassified as a non-medical device, users lose this reimbursement pathway — and device costs that often run into thousands of dollars become entirely out-of-pocket expenses. On the question of access rights, the Americans with Disabilities Act (ADA) explicitly protects the right of wheelchair users to access public spaces, but protections for "personal mobility devices" are subject to interpretation, with varying enforcement standards across states. This creates potential risk for users who rely on these devices for daily mobility.

Conclusion

Strutt's positioning of its electric wheelchair as "not a wheelchair" is a textbook case of product strategy versus regulatory friction. It reminds us that a product's definition is shaped not only by its function and form, but also by the regulatory environment it operates within. As personal mobility technology continues to evolve rapidly, building a modern regulatory framework that encourages innovation while protecting users will be a shared challenge for the industry and policymakers alike.