# K060150: Smartstep System/Smarstep Clinic System

- Pathway: 510(k) (Special)
- Applicant: Andante Medical Devices, Ltd.
- Decided: Feb 23, 2006 after 34 days
- Product code: IRN (Device, Warning, Overload, External Limb, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5575
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K770405 (1977). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023161: Smartstep System, Andante Medical Device, Ltd. (2002) Summary page 1.

## Indications for use
The SmartStep T System/ SmartStepT m Clinic System is intended to sense the amount of weight applied to the planter surface of the foot during rehabilitation. The System alerts the user and/or therapist with alarm when the weight exceeded the pre-selected value. Furthermore, the SmartStepTM System/ SmartStep TM Clinic System is intended to be used in any situation in which therapist and/or patient would benefit from objectively assessing the amount of weight that is being applied to a lower limb.

Source page: https://510kreport.com/device/K060150
Methodology: https://510kreport.com/methodology