stappone Can Now Be Used in Clinics and Medical Practices Across the United States

As a 510(k)-exempt Class II medical device, our smart insole is launching in the U.S., and treatments using it may be reimbursable.

What the therapist’s eye can’t see, stappone shows in color. Our sensor insole measures how the foot is loaded with every step and displays it instantly on a tablet.
Proven in European clinics, stappone is now officially registered with the FDA in the U.S. as a Class II medical device, exempt from 510(k) requirements. The 510(k) is a review process that many medical devices must complete before entering the U.S. market to show that they are as safe as devices already on the market. For device categories whose use is well understood and clearly regulated, the FDA waives this requirement, and stappone falls into one of these categories.

What this means
• For patients: They see live what their foot is doing and understand exercises in minutes instead of months.
• For practices: They get objective measurements instead of estimates, and the system fits quickly into daily routines.
• For reimbursement: Depending on the payer, services using stappone may be reimbursable through remote monitoring, biofeedback, or therapeutic CPT codes.
An example: An 80-year-old patient from Austria spent more than a year training his foot arch without being able to put his therapist’s instructions into practice. With stappone, he understood them in less than five minutes.

Take a look at the video below, what CEO Peter Krimmer is commenting on the FDA registration!

For professionals

stappone captures stance and swing phase duration, cadence, step length symmetry, center of pressure (CoP) trajectory, and peak plantar pressure distribution in real time. The lightweight sensor insoles work in the clinic, on the treadmill, and during free walking. This gives physical therapists, podiatrists, orthopedic specialists, and rehabilitation centers an objective tool for gait analysis and partial weight-bearing training.