510(k) · Cleared
ClearedSensor Walk
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Otto Bock Healthcare LP · IQI Orthosis, Limb Brace
Cleared on May 3, 2006 after a 215-day review. The FDA summary names its predicate without a number.
- Decided
- May 3, 2006
- Review
- 215 days
- Class
- Class I
- Product code
- IQI
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IQI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | OTTO BOCK FreeWalk Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All IQI devicesIQI Orthosis, Limb Brace: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IQI
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · IQI
Too few IQI 510(k)s in any year since 2007 to give a median.
Recalls per year · IQI
3in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IQI
8in 2025
MAUDE reports naming product code IQI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 5 |
| 2008 | 0 | — | 0 | 12 |
| 2009 | 0 | — | 0 | 33 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 0 | — | 0 | 16 |
| 2012 | 0 | — | 0 | 31 |
| 2013 | 0 | — | 0 | 36 |
| 2014 | 0 | — | 0 | 39 |
| 2015 | 1 | — | 0 | 20 |
| 2016 | 0 | — | 2 | 14 |
| 2017 | 0 | — | 0 | 93 |
| 2018 | 0 | — | 2 | 19 |
| 2019 | 0 | — | 0 | 19 |
| 2020 | 0 | — | 0 | 11 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 3 | 3 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (136 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052771 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052771: Sensor Walk.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052771
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026