I have alot of experience in this. I’ll give you the whole story.

When I started with the Handi-Straps commercialization everyone asked me for testing. Manufacturers, big companies/end users and insurance companies. I thought this was a hurdle I could not overcome but I did. I did not expect a hurdle this big. I still have sold to many Fortune 100 companies and every division of military.

Turns out that the biggest testing lab known, Underwriters Laboratory reviewed my invention and just did not have a classification to test it against so they declined testing which usually costs about $10,000

There are other RESPECTED, not gov’t certified or anything like that will test your medical related inventions for about $10,000 to $20,000

As far as Federal agencies. The very top directors of the CDC and NIOSH (National Institute of Safety and Health) know about me and even had a meeting to figure how to mandate a study for Handi-Straps. They declined and told me how hard it is to get the authority to study something that is not doing harm. They basically go after things that are doing damage.

I still tried for testing and got some technical testing with numbered results from a very large physical therapy/clinic with multiple locations in many states and that info is on my website. I also got the Texas Governor’s office to test with military and they gave me an exact response that they allowed me to put on my website. They ONLY did this they said to let military know of the great help they found with Handi-Straps in controlled testing of specific military tasks in that division of military.

Currently I have one of President Obama’s Chiefs trying to get a study mandated but that is going slow it seems, I have to follow up.

The FDA is for FOOD and DRUG. Your invention should not need to be certified at all by them. There are millions of ergonomic devices out there. There really is no certification anywhere that I know of, but start hurting people and they will be checking you out real soon.

My product is distributed by a few ergonomic/physical therapy/chiropractic distributors. Maybe start there. Just being listed with them will give you credibility and give you access to any possible testing opportunities.

So, are knee scooters certified or otherwise regulated by FDA? What about regular crutches? I’ve found references that they (crutches) are exempt from FDA, but it wasn’t clear if they would still require registration of the company manufacturing/selling them.