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Special Needs, Mobility and Disabled Use Information and discussion for those with special needs interested in the Segway.

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Old 10-18-2014, 11:15 PM   #21
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Originally Posted by bgrh@mac.com View Post
Hate to be a pain, but, the reason the SegSurrey never went into production is that it violates FDA rules regarding wheelchairs. A wheelchair needs to have more than two wheels. A wheelchair is for a person restricted to a sitting position. Since the SegSaddle can be used standing or sitting it is NOT a wheelchair. However, the SegSurrey, a SegSaddle with a platform instead of a bike seat, can't be used standing up, is therefore a wheelchair, and therefore violates FDA rules. Obviously I didn't know all this when we first designed it, because we designed it to be switchable from one mode to the other.

Now, there is a Swedish solution that is wheel chair height, and does exactly what you want, and since it's made in Sweden it doesn't violate US rules. You just have to import it on your own.

It's called the AddSeat. http://addmovement.se/en/theaddseat/
I was not aware of an FDA definition of a wheelchair that required it to have more than 2 wheels. Could you post a link to that FDA document?

I wonder if this might be a good place to focus for someone looking to make a change...
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Old 10-20-2014, 04:44 AM   #22
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Thanks, Brian. The AddSeat looks great:





http://addmovement.se/en/theaddseat/
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Old 10-20-2014, 10:38 PM   #23
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Karl:

I think you are correct - it's not the FDA - it's the standards. I was told about this by a senior person at the VA responsible for wheelchairs. When I went looking for the standards I found this,

http://www.resna.org/sites/default/f...0140418rev.pdf

The standard costs $900... I didn't download it. What I was told is that a medical device requires at least three wheels, and if you can't stand up in the device, i.e., if you are restricted to a sitting position, that does meet the FDA definition of a wheelchair, at which point the Standard is applied to you.

The FDA rule is simple.


[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2014]
[CITE: 21CFR890.3860]
See Related Information on Powered wheelchair. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 890 -- PHYSICAL MEDICINE DEVICES

Subpart D--Physical Medicine Prosthetic Devices

Sec. 890.3860 Powered wheelchair.
(a) Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

(b) Classification. Class II (performance standards).

So, as long as you don't claim any medical purpose for the device you can market it, but, since the market is folks with a medical need, you get stuck... I got cautioned by an FDA official for using the phrase "Freedom to Move". He thought it was too close to the line...

Bottom line, that's why we abandoned the SegSurrey and focused on the SegSaddle.

Final note, the SegSaddle is currently out of production, but, we've signed an agreement with a manufacturer with good global distribution and we hope it will be back in the market in 2015.
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Old 10-20-2014, 11:19 PM   #24
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Quote:
Originally Posted by bgrh@mac.com View Post
Karl:

I think you are correct - it's not the FDA - it's the standards. I was told about this by a senior person at the VA responsible for wheelchairs. When I went looking for the standards I found this,

http://www.resna.org/sites/default/f...0140418rev.pdf

The standard costs $900... I didn't download it. What I was told is that a medical device requires at least three wheels, and if you can't stand up in the device, i.e., if you are restricted to a sitting position, that does meet the FDA definition of a wheelchair, at which point the Standard is applied to you.

The FDA rule is simple.


[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2014]
[CITE: 21CFR890.3860]
See Related Information on Powered wheelchair. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 890 -- PHYSICAL MEDICINE DEVICES

Subpart D--Physical Medicine Prosthetic Devices

Sec. 890.3860 Powered wheelchair.
(a) Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

(b) Classification. Class II (performance standards).

So, as long as you don't claim any medical purpose for the device you can market it, but, since the market is folks with a medical need, you get stuck... I got cautioned by an FDA official for using the phrase "Freedom to Move". He thought it was too close to the line...

Bottom line, that's why we abandoned the SegSurrey and focused on the SegSaddle.

Final note, the SegSaddle is currently out of production, but, we've signed an agreement with a manufacturer with good global distribution and we hope it will be back in the market in 2015.
Brian,

I thank you for your candor, and your information. I wish you luck with your business, and your devices.

I must also add however, that I have been told incorrect data many times from government employees who did not actually understand what they were talking about, but did not know that they did not know what they were talking about. Even once informed they were wrong, it did not matter to them, as they were not used to, nor willing to document what they said.

VA officials are government employees. FDA rules are administered by government employees. These rules, if they actually exist, may be germane when dealing with these two agencies, but that is a far cry from making them universal or binding...

You know best what to do with your company, your time and your battles. I would not attempt to say otherwise. Whatever certification process you decide to embark upon or not is your own choice. I wish you luck with this as well.
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Old 10-21-2014, 11:14 AM   #25
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Quote:
Originally Posted by Gimpy guy View Post
While all those conversions are very cool they all share the same failure for use as a true powerchair. The control shaft up front makes it cumbersome to say the least.

There is a one that is a chair, the Ally.
Now if I could just buy one!
Hi Gimpy Guy.

Moving the steering off to one side is a very simple procedure. I initially had the same design, but in doing high speed turns, my wife (T5 para) was very unstable. I then changed the design back to the original. The steering columns is also height adjustable, and I could very easily make a short knob type stick, that could sit front and centre, and fit under a table.

Most guys with stronger transfers, do so without removing the steering shaft. It seats with a tapered plate, so removal is very very quick. It also weighs next to nothing as I have fabricated it from alluminium.

Below is a link to our Facebook page for almost daily production updates, and a link to prototype no 3 with side steering.

Cheers.
Mario.

Sorry, I can't post links yet, but please look for my channel on youtube, midvaal1.
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Old 10-21-2014, 02:06 PM   #26
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Hi Gimpy Guy.

Moving the steering off to one side is a very simple procedure. I initially had the same design, but in doing high speed turns, my wife (T5 para) was very unstable. I then changed the design back to the original. The steering columns is also height adjustable, and I could very easily make a short knob type stick, that could sit front and centre, and fit under a table.

Most guys with stronger transfers, do so without removing the steering shaft. It seats with a tapered plate, so removal is very very quick. It also weighs next to nothing as I have fabricated it from alluminium.

Below is a link to our Facebook page for almost daily production updates, and a link to prototype no 3 with side steering.


I'm as strong as you're going to find and the center shaft is a problem on many levels. Lowering and removing things are not convenient if it needs to be done fifty times a day.

Look its a great product, as a speciality seat. As a viable chair option it's just too flawed.
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Old 10-25-2014, 05:02 PM   #27
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Quote:
Originally Posted by Gimpy guy View Post
I'm as strong as you're going to find and the center shaft is a problem on many levels. Lowering and removing things are not convenient if it needs to be done fifty times a day.

Look its a great product, as a speciality seat. As a viable chair option it's just too flawed.

Thx for your input, I know we cant be all things to all people. The Segfree started as a single unit built for my wife, and as such I designed to a very narrow scope. The Segfree is meant as a second chair, and not a primary one.

Centre controll, very easy to remove, actuator driven seatpan for very aggresive riding, and higher seat height for better offroad performance, and a more natural walking height when next to me, that was our scope.

For me, I just wanted to walk hand in hand with my wife again...

I value your guys input tremendously. My wife only got hurt 8 Dec 2012, so I have been working on this for a very short time. Ultimately I want the seat to drop down under a desk, or restaurant table, and lift almost as high as the ibot.
With new technology like spiral lifts , I am one step closer!

Hopefully I can realise these ambitions, but with a target price of under $10,000-00 including Segway, I hope the Segfree will get a whole lot of people into the woods, and onto the beach!
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Old 01-30-2015, 08:53 AM   #28
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I am looking for "stablizers" (i guess i would call them). Hand activated that hold the unit upright, stationary and stable so You can get on or off without it moving. In an emergency shut down they would give you extra time to get off the unit.

Many of us do stand then use many of the devices discussed here as temporary seats. Yes we can step up and down, and get off in the required 10 seconds. But a little extra stability would be convenient. (Sometimes using a wall just isn't an option...)

Thanks for all the posts and info from those of us that read more than post!

Grace
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Old 01-30-2015, 11:36 AM   #29
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I had conersation with www.seg-solutions.com and they are working on a stabilizer solution. I am waiting patiently for an email that it's out of their shop and onto the Segway. I will post when I get verifcation it's ready.

Perhaps if you and others email regarding interest it would be helpful to reinforce the fact that there is a market for a universal Segway stabilizer/kickstand.

Last edited by rickb; 01-30-2015 at 11:41 AM..
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Old 01-30-2015, 11:46 AM   #30
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Quote:
Originally Posted by gbrandwood View Post
Thanks, Brian. The AddSeat looks great:





http://addmovement.se/en/theaddseat/
I had email conversation with the addseat inventor and she stated concerns and issues about USA FDA rules and regulations would prevent the addseat from being sold and marketed in the USA. It is a very high cost unit.
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