Dona Bhamra It is a medical device. As Joanne said, requirements depend on where you intend to market your device. According to Health Canada, it is class I medical device and in US, it is class II medical device. Each Country has specific Regulatory requirements.

Robert Christensen I don't have any great feeling about them being classified as a device. Interestingly, as a surgeon- innovator in my 91st year I just found out I have Poly Myalgia Rheumatica which causes much weakness and pain in many muscles, now causing me to begin to look into a scooter for my disability. I will look into the lighter weight scooters which will be helpful for my problem. Anyone have any excellent ideas?

For the U.S. there are standards outside of 60601 that may apply to the device, depending on how the intended use is phrased and the specific technology. It would be wise to consult with a certification body, before trying to go to market to make sure your bases are covered. You can contact me if you have any questions

William (Bill) Jackson The FDA and ISO has a good number of guidelines and standards for scooters, wheelchairs, etc. To market they would need a 510 k. It is not easy but I have submitted over 40 510 k's for these types of devices

Dona Bhamra http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080524.htm.

Hi Chris, Interesting story. I can possibly help your neighbor with finding manufacturers. I currently help startups in the same manner on a pro bono (i.e. no charge) basis. Feel free to contact me at your convenience.

Anthony Zelinko You need to look at the reimbursement criteria under Obamacare with a fine tooth comb. Your manufacturing and materials cost are critical for success. Contrary to popular belief having the best product or even a patent is not a sure fire winner. Determine market volume vs manufacturing costs vs reimbursement. Then calc whether the product profit est. Over a 5 to 6 yr period. You will lose money for the first few years of manufacturing if your building a business &marketing with distribution.
Taking all this into account you want to tighten up your legal or patent position by planning for future improvements & extend it's utility or life. Then shop your package to current wheelchair manufacturers. Let them absorb all the costs and you receive the royalties.

Don't fall in love with the idea that manufacturing your product is what you have to do. Many here will offer free advice and attorneys involved in all aspects will bleed you dry.

Worked with a company,spent months working together. At end of the day they basically stole proprietary rights even though they signed non disclosure agreements. Now I had every right to prosecute but that would stretch out a legal battle and even if I won at what cost.
Basically watch your back.

Julie Omohundro I will add that you can get it on the US market via the 510(k) process, then that means it is "substantially equivalent" to one or more devices that are already legally marketed in the US.

This immediately raises the question of why anyone is going to want to buy this one instead of the one(s) that are already available. This isn't to say there isn't good reason why they might prefer his device over the others, but that's one of the first questions I ask when I hear "510(k)," and needs to be answered earlier rather than later.

William (Bill) Jackson All the testing for this type of device would not be inexpensive, if electrically controlled, the two safety standards plus the scooter ( wheelchair standards) and let us not forget the software standards for the control mechanism could run into the thousands of dollars.

You will need a project plan no matter what source of action to take.

Good luck and my recommendation is talk to existing scooter companies first not scooter distributors,

Julie Omohundro Here is a link to a warning letter FDA issued to a manufacturer of electric scooters a few years ago:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm252701.htm

FYI, getting a warning letter from FDA is not a happy experience

There is a good chance his scooter would be regulated by FDA under 21 CFR 890 Subpart D (Physical Medicine Prosthetic Devices):

http://www.gpo.gov/fdsys/pkg/CFR-2012-title21-vol8/pdf/CFR-2012-title21-vol8-part890-subpartD.pdf

Don't waste one second of your life trying to decide if you agree that an electric scooter meets the legal definition of a medical device. Just accept it and move on.

Before he goes any farther, he needs to do his business homework. He need to determine up front whether his device will generate enough profit to warrant the expenditures needed to develop it, get it legally on the market, and keep it there (eg, avoid getting Warning Letters from the FDA).

This is not a DIY proposition. He will need to avail himself of a range of different types of expertise and all of us experts want to be fairly compensated for our hard-earned knowledge.

I don't want to discourage him, but I do want him understand that it can be very difficult for someone without prior experience in the development and marketing of medical devices to bring a new medical device to market. Unfortunately, it is not always so difficult to waste a lot of time and money in an effort to nowhere.