Andante Medical Devices, Ltd.
IsraelFDA applicant, unverified
- Devices
- 1
What Andante Medical Devices, Ltd. makes
Andante Medical Devices manufactures the SMARTSTEP System and SMARTSTEP Clinic System, which are designed for gait analysis and rehabilitation assessment in clinical and home settings. These systems provide data-driven insights to support patient mobility evaluation and therapeutic planning.
The company’s products fall under FDA Class II regulation and are listed via the 510(k) pathway. The devices are based in the United States.
Catalogue
Smartstep System/Smarstep Clinic System Ref K060150
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Andante Medical Devices, Ltd. have in the registry?
The registry currently lists 1 device for Andante Medical Devices, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Andante Medical Devices, Ltd.'s devices?
Among its 1 most recently registered device, Andante Medical Devices, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Andante Medical Devices, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Andante Medical Devices, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Andante Medical Devices, Ltd. in the registry?
The most recently registered devices listed for Andante Medical Devices, Ltd. include SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM.