As written by the FDA regarding the walkaide I also found this information. In my opinion, this may add to why the product isn't found internationally. I put an asterisk (*) in front of information of great importance/need to know for readers to have an informed decision by high credibility/FDA. Attached you will find the link to find/read the document in its entirety.

"The Agency acknowledged your commitments to improve your firm's compliance with the quality system regulation. (*) However, your firm's response does not completely resolve several inspectional observations for the reasons explained in this warning letter. (*) Your firm has not implemented a formal quality plan to improve the quality of your devices and verified its effectiveness. (*)The Agency expects your firm to work closely with the contract manufacturer in order to correct quality issues of your devices, and will conduct follow-up inspections to assure that your firm's corrections are adequate.

(*) These violations include, but are not limited to, the following:

Quality System Violations

(*) 1. Failure to sufficiently evaluate and select potential contractors, suppliers, and consultants on the basis of their ability to meet specified requirements, including quality requirements, as required by 21 C.F.R. § 820.50(a). FDA 483 Item 11.
Specifically, your firm has not adequately evaluated the contract manufacturer for its ability to meet your quality requirements despite the fact that your firm experienced quality issues which resulted in many complaints and two product removals (recalls) initiated between December 2006 and February 2007, and August 6, 2008.

(*) Your response is incomplete. (*) Your response indicated that your firm has been evaluating the contract manufacturer in the past two years but that your firm's evaluation has not been formalized. Your firm plans to put in place a formal quality plan for the contract manufacturer with specific requirements to be met in the next 30 days. The Agency expects your firm to verify the effectiveness of your quality plan in order to effectively correct the past quality issues and prevent new quality issues from occurring in the future..." (cont.)

(*) "2. Failure to establish and maintain adequate procedures for identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems, as required by 21 C.F.R. § 820.100(a)(3); and (***) failure to verify or validate the corrective and preventive action and document its results to ensure that- such action is effective, as required by 21 C.F.R § 820.100(a)(4) and (. FDA 483 Item 7. Specifically,...” (cont.)

This public viewable document for those that go to the FDA site or follow this link to bring you there directly is:

http://www.fda.gov/ICECI/EnforcementAction.../ucm1048075.htm

If this page was moved view this site info and note the date of it:
http://www.fda.gov/ICECI/EnforcementAction.../ucm1048075.htm
This should allow you to know where to find information to make a better informed decision per FDA's findings.

Aah McCann, you've done it again!

When I followed your link I got a message back which said that page didn't exist. I am interested in all of the info you can give both negative and positive before I make up my mind on purchasing a walk aide and whether it will be after my convertible or before. Please post a working one because what you posted in the topic could mean they haven't been through some sort of quality assurance programme or not filled out some forms and doesn't mean particularly that there is anything particularly wrong with the product itself. It could all just be part of getting it FDA approved which is extremely difficult from what I hear. If you are interested in participating in the debate on the walk aide, perhaps you should start posting back to the original one instead of starting all these separate topics with mysteriously odd titles that don't seem to relate to what they contain.

All I am saying is it gets confusing finding relevant posts and info when they are all spread out as they are. Could we possibly keep this all in the one post or perhaps start up a new one which mentions in the topic the name walk aide. If you are interested in consumers making an informed choice then perhaps it would make it easier for them if all the info were in the same place. While you are at it, perhaps you could post the website of the company who sells the NMES equipment you used. While I have seen some pretty good guesses by others, I am still not sure I have seen anything other than a phone number from you thus far.

One other thing, whilst FDA approval is generally looked on in high regard, the FDA is an American governmental regulatory group and doesn't necessarily apply in countries outside the USA

Thanks

Actually if the link is properly followed you will get to the spot mentioned. If you do not get there directly the FDA may have moved it.

I am not putting down the product simply stating where and how people should and can find credible information.

I have no personal problems with the company or product. What I state is my supported opinion by documents, research, experiences and perspectives of mine and others("users") and only want people to know where to see and/or find information. Problem is the deadline dates given for corrective actions to take place; some meet them while others don't/fail.

Try this link to go view the FDA's warning letter and quality system violations (view the date also):

http://www.fda.gov/ICECI/EnforcementAction.../ucm1048075.htm

Thanks for fixing it but I didn't know there was any other way to make a link work other than clicking on it or pasting into the web browser. Is there another way? The first one still isn't working so perhaps they moved it? To me it appears the rear case cover was shorting out and reversing the current to the electrodes which won't actually make a difference to the way the unit works unless both contacts are putting out the same polarity in which case nothing will happen. This would be a nuisance a long way from home to say the least.

The other issues sound like they could perhaps be teething trouble a lot of companies developing things go through trying to get things to market. What you have posted though is of value though and it is a shame you couldn't post it into the walk aide post as I think it would possibly help with the discussion somewhat. I would definitely want a guarantee that nothing like the fault mentioned above didn't occur though and definitely wouldn't be purchasing if faults like that were the norm. Having said that though, I have had to take back two expensive pieces of electronic equipment in the last five years. Perhaps the problem is that the tight clearances and tolerances introduced recently with the advances in electronic and CAD CAM technology means occurences like this could be more common than we know about. Personally though I think medical equipment design should be just that one step above the rest as we need to rely on this sort of thing far more than a user of i-pod or video equipment which is why FDA compliance is and should be so strict and rigidly controlled.

On a lighter side note, the "Aah McCann, you've done it again" was a joke which probably only Australians and Kiwis will get. There is a company McCain (slightly different spelling) Foods Limited which sells food in New Zealand, Australia and I think Canada. They had a rather nasty habit of including (by accident) frogs in their frozen veges. I remember two reports of it I think and one may have been a mouse but I may be wrong. Then last year or early this year they were also picked up for including deadly nightshade berries in their frozen peas and as far as I remember it was quite an unbelievably high percentage, perhaps almost 20% in some packs. Their advertising slogan in those days was "Ah McCain you've done it again". Each time we saw a food scare from them on TV my sister and I would both repeat their ad slogan. Just goes to show that some of the manufactured things (including food) we buy have probably never even been seen by the human eye. Anyway, sorry for the post hijack.
Once again, it would be good to see this on the walk aide topic.