80% of the new scooter FDA Serious Injury reports are from tip overs and falls. Many of these new scooter users could be placed in unnecessary, increased risk situations because of the way the regulatory process and scooters work (or do not work)!
There is the presumption that “FDA Approved” products must be safe. In fact, it is a violation of FDA Regulations to claim your 510-K product is “FDA approved”.
A 510-K is a Class II Medical Device premarket
process in which
paperwork for clearance
to sell the product.
The FDA does not test products for 510-K’s. The FDA reviews 510-K premarket paperwork voluntarily provided by the manufacturer/distributor. The FDA relies on the honesty of the applicant to do the required RESNA tests and accurately report the results.
As we have previously reported, we are very concerned about the safety of super short, narrow, lightweight scooters for everyday indoor usage. A major U.S. manufacturer’s owner’s manuals warned these scooters are so unstable that driving over a 1/2” indoor threshold or hitting an object in reverse on a flat surface could cause the scooter to completely tip over.
The following video graphically demonstrate how unstable a less than 40” long scooter can be.
Competitors Travel Scooter Fails U.S. Testing Requirements
This scooter has a FDA 510-K listing and is currently reimbursed by Medicare. The manufacturer owners manual rated the scooter safe for a 250 lb. user at a 13 degree incline. The driver is 240 lb. The scooter is on a flat level concrete surface. The test is per the RESNA Standard. The seat is in the worst case position as far up and back as the seat allows. The scooter is traveling backward and is not stopped by hitting an object. The scooter throttle is simply released and the scooter tips completely over just by its own braking system. Does the scooter tip over every time? No; but this is a flat surface. We are not crazy enough or don’t have the guts (take your pick) to repeat this test on a 5 degree incline, no less a 13 degree ramp.
It is not possible for new technology to make these super short, narrow, lightweight scooters overcome the basic laws of physics. What we really have is another import manufacturer inaccurately reporting the safety of their product. Unfortunately, another generation of senior citizens may have to be hurt to relearn the lesson of 15 years ago that these units are not safe in everyday use.
Medicare’s first three new scooter codes call out a scooter with only a 6 degree incline rating required. These new scooters are basically back to the original small size, low incline rated scooters that the travel industry moved away from 15 years ago because of injuries.
Medicare is paying for the scooter to be used indoors, but limited outdoor use is allowed. (We believe scooter users have a need and right to vote, go to the doctor, the pharmacy, the grocery store and church safely.) Two new FDA Serious Injury reports accurately predict what will happen if dealers are required to supply super short, narrow, 6 degree scooters instead of the 45” or 46” long - 24” wide, much safer industry standard units. The reporting manufacturer’s scooter is 40” long and 19.75:” wide. The first report states Serious Injury, Required Intervention “Tipped backward going up a ramp.” The second report states Serious Injury, Required Intervention “Customer rode unit on uneven terrain.”
In this day and age of undersized and unsafe scooters, we recommend that you confirm that the "Product you buy Passes the test, not just bears a label"