After a small hiatus, the Mobile Medical Apps blog series is back! Today we'll take a look into wellness and weight-loss applications.

The market is flooded with mobile applications focused on wellness, from circuit training (I love the Sworkit app) to running (Nike+ is great to track runs), calorie logs (my family is using MyFitnessPal at the moment) to applications interfacing with devices (BodyMedia, Jawbone Up, etc.).

The use of these applications has revolutionized the way my family and I look at fitness, especially in that it begins to remove all of the tell-tale excuses that are prevalent when trying to lose weight or build muscle:
- I don't have time to workout! Sworkit allows the user to set workout circuits from 5 to 60 minutes. Everyone has 5 minutes to quickly "Swork out!"
- I don't know how much I burn with my workouts! Many apps (like Nike+, MyFitnessPal) can provide estimates of calorie burn. Also, the BodyMedia, and Jawbone Up products are able to calculate burn for those of us that like require accurate and personal data.
- It's just too hard! Too hard to pull your phone out, scan a few barcodes, and log your lunch? I don't think so. The MyFitnessPal app allows the user to scan the barcodes of the food containers for quick nutrition inputs. Manual entry of food becomes complicated, time consuming, and dissuades users from continuing (either using a written log or other electronic logs - LoseIt!, Sparkpeople.com, Weight Watchers, etc.). MyFitnessPal has taken that annoyance away!

Enough with my new-found interest in fitness, what does this have to do with the FDA? Wellness products currently live within a gray area of the FDA. The Jawbone Up and the BodyMedia armband track activity, sleep, and their mobile apps allow for food logging. All of this results in a dashboard of data to characterize the user's fitness and health. As of this morning, a quick scan of the listing and registration database with the FDA shows BodyMedia, among others, as a device under product code IKK - System, Isokinetic Testing and Evaluation under the Physical Medicine review panel (Class II, 510(k) Exempt). Under 21 CFR 890.1925, it is defined as a "rehabilitative exercise device intended for medical purposes, such as to measure, evaluate, and increase the strength of muscles and the range of motion of joints."

Conversely, the Jawbone Up did not appear in the IKK product code search results, nor did it appear in individual searches based on the product name or manufacturer. How, then, can Jawbone and other manufacturers of these monitoring systems continue to sell product outside of FDA oversight? Likely, their regulatory strategy is to avoid making claims of rehabilitation or medical purposes as seen in the 21 CFR 890.1925 above. That strategy carries potential business risk, but both strategies carry validity.

So, not only do mobile apps have the challenge of determining whether their software is a device, many of them have the second step of working within a product regulation that is equally muddled.

-RTK

Image Credit: Frank B. Daugaard on Flikr

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