# K052771: Sensor Walk

- Pathway: 510(k) (Traditional)
- Applicant: Otto Bock Healthcare LP
- Decided: May 3, 2006 after 215 days
- Product code: IQI (Orthosis, Limb Brace)
- Device class: 1
- Regulation: 21 CFR 890.3475
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) OTTO BOCK FreeWalk: named in the summary without a submission number

## Indications for use
The SensorWalk is intended to lock the knee joint during the stance phase and to unlock the knee joint during the swing phase when walking forward on level surfaces. It is intended solely for the orthotic fitting of the lower limbs of patients who are community ambulators and who: * Exhibit knee instability in the sagittal plane while bearing weight during the stance phase of their gait cycle; * Have hip extensor strength of at least grade 3 (against gravity); * Have the muscle strength in their torso or pelvis required to swing the SensorWalk forward while they are walking; * Have a gait in which the step length on level ground exceeds the length of the opposing foot; * Weigh 300 pounds or less; and * Are able to understand and carry out the instructions.

Source page: https://510kreport.com/device/K052771
Methodology: https://510kreport.com/methodology