It's an intriguing idea. By extension, every device used to maintain a healthy lifestyle might similarly be classified as a medical device. If I were a bicycle manufacturer, I'd be quite happy keeping things as they are.

Lars Oddsson The by far most broadly applicable and cost effective intervention we have against disease in general would be exercise and nutrition. The problem is compliance on a broader scale. We have a culture of popping a pill (especially I believe in the U.S.) for most every ailment and expecting a medical device for everything else. I think emerging wearable technology will become increasingly important in the near future and even a necessity and requirement sooner than we think to help us stay healthy, motivated and engaged.

christophe dohen interesting. I went to a conference a month ago with a presentation from a large and well-known company (not mentionning). The business manager was explaining how its company wants to focus on the medical market and his idea was not focus particularly on medical devices the way we all think but more on all the other devices we use daily and essential for an healthy life.

Klaas Van 'T Klooster As a legacy physical therapist I can only smile at a statement that "No currently approved medication can rival the effects of exercise and a healthy lifestyle". Because there are no big budgets available (as for meds research) for exercise clinical research, published outcomes like this are rather scarce.
However, I am confident that when a smart stationary (or regular) bike manufacturer makes some creative slight disease specific modifications (like additional stabilizers?) and approve the design as a class I medical device, that with the results of the literature clinical evidence, Health Care Insurers are willing to reimburse the substantial increase costs because it is a medical device...

Klaas Van 'T Klooster As a legacy physical therapist I can only smile at a statement that "No currently approved medication can rival the effects of exercise and a healthy lifestyle". Because there are no big budgets available (as for meds research) for exercise clinical research, published outcomes like this are rather scarce.
However, I am confident that when a smart stationary (or regular) bike manufacturer makes some creative slight disease specific modifications (like additional stabilizers?) and approve the design as a class I medical device, that with the results of the literature clinical evidence, Health Care Insurers are willing to reimburse the substantial increase costs because it is a medical device...

Steve Weisner FDA sites shows 5 510(k) clearances for various bicycles, obviously more on the exercise end. They are under the categories: ISD Exerciser (21CFR 890.5360) , Measuring or DRT Cardiac Monitor (21CFR870.2300). You would probably find more devices (e.g. treadmills) if you searched for 'exercise'.

Of course bicycles keep cyclists healthy. I am surprised that is news.
By the same evidence, televisions and motor cars cause a lot of disease.

Mia Spiegelman BSc, RAQC Some bikes are already Medical devices as they provide data for the management of different physical conditions - they are diagnostic devices. not aware of a bike that has approval as a therapeutic device though... but I think this is what this article is about. The difficulty around the therapeutic device is that it is very hard to have an effective therapy unless it is in physician office because of lack of compliance. interesting.

Jean Bigoney, RAC, CQE There is a perceived grey area between various types of exercise equipment (not just bicycles) and medical devices. Of course exercise has health benefits! Even FDA is aware of that! :)

What matters is how the device is marketed.

Here is what FDA has to say on the subject:

"Note that FDA regulates exercise equipment only if the equipment is intended to be used for
medical purposes, such as to redevelop muscles or restore motion to joints or for use as an
adjunct treatment for obesity. FDA does not regulate exercise equipment intended only for
general physical conditioning and/or for the development of athletic abilities in individuals
who lack physical impairment. Therefore, it is not necessary to notify FDA of an intent to
market a device if it will not be labeled or promoted for medical uses. However, FDA will
regulate the equipment and may require premarket notification if any promotional material
appears which makes medical claims after marketing begins"

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080405.pdf

Use it or lose it is still a valid scientific statement.

Pat Chelf To all of the great folks who commented to me about my sharing of the study summary on exercise as a preventive and/or palliative treatment for some Alzheimers/dementia etc. The comment about the "bike as a medical device" was kind of a joke. The bike was meant as a symbol for exercise generically. I should know better than to go literary on a bunch of scientists and engineers....

I don't understand people who don't understand this from day 1, and the other percentage who are so attached to what they learned in school that common sense goes out the window. I know this problem (and healthcare in general) runs much deeper than that, but still, I don't get it. We're creating all these algorithms to sell back-end software data. Why not put that energy toward the front end of the medical space to determine what patients really need or could be doing before hitting the medicine cabinet.

http://www.sunrisemedical.com/mobile/products/product-list.aspx?id=778&brand=541 #OneSunrise

Julie Omohundro Jessica, no ka-ching.