# K023161: Smartstep System

- Pathway: 510(k) (Traditional)
- Applicant: Andante Medical Device, Ltd.
- Decided: Dec 10, 2002 after 78 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: 2 generations back to K770405 (1977). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950656: Ped Alert, Orbitec Technologies Corp. (1995) Summary page 2.
- K955034: Forceguard, Impact Monitors, Inc. (1996)
- K991313: Accutred Shoe, Orthopedic Technology Research, Inc. (1999) Summary page 2.

## Most influential descendants
- K060150: Smartstep System/Smarstep Clinic System (2006), 0 descendants of its own

## Indications for use
The Smartstep System is intended to sense the amount of weight applied to the plantar surface of the foot during rehabilitation. The device alerts the user andor therapist with alarm when the weight exceeded the pre-selected value. Furthermore, the Smartstep System is intended to be used in any situation in which therapist andor patient would benefit from objectively assessing the amount of weight that is being applied to a lower limb.

Source page: https://510kreport.com/device/K023161
Methodology: https://510kreport.com/methodology