510(k) · Cleared
ClearedKeeogo Dermoskeleton System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B-Temia, Inc. · PHL Powered Exoskeleton
Cleared on Sep 9, 2020 as substantially equivalent to K181294 (Honda Motor Company, Ltd., 2018) after a 92-day review. Its family tree reaches back 4 generations to 2014.
- Decided
- Sep 9, 2020
- Review
- 92 days
- Class
- Class II
- Product code
- PHL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN130034 (2014). No later device cites it as a predicate yet.
- Root · 4 generations backDEN130034 RewalkArgo Medical Technologies, Inc. · 2014
- 3 generations backK143690 Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Ekso Bionics, Inc. · 2016
- 2 generations backK161443 Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Ekso Bionics, Inc. · 2016
- 1 generation backK181294 Honda Walking Assist DeviceHonda Motor Company, Ltd. · 2018
- This deviceK201539 Keeogo Dermoskeleton SystemB-Temia, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN130034 | Rewalk | Argo Medical Technologies, Inc. | 2014 | — |
| −3 | K143690 | Ekso™ (version 1.1) and Ekso GT™ (version 1.2) | Ekso Bionics, Inc. | 2016 | — |
| −2 | K161443 | Ekso™ (version 1.1) and Ekso GT™ (version 1.2) | Ekso Bionics, Inc. | 2016 | — |
| −1 | K181294 | Honda Walking Assist Device | Honda Motor Company, Ltd. | 2018 | — |
| 0 (this device) | K201539 | Keeogo Dermoskeleton System | B-Temia, Inc. | 2020 | — |
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 PHL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PHL device
- #1 K250904 Atalante Xscore 15.0 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K181294 | Honda Walking Assist DeviceSummary page 4…exoskeletons Device Classification: Class II Premarket Notification: K181294 Indications for The KeeogoTM Dermoskeleton System is robotic exoskeleton that fits Use: orthotically on the us… | 2018 |
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.
What does this lineage say?
- The line of descent spans 6 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K181294.
How does its category compare?
All PHL devicesPHL Powered Exoskeleton: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · PHL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PHL
177in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PHL
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PHL
6in 2025
MAUDE reports naming product code PHL, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 4 | 145 | 0 | 4 |
| 2017 | 2 | — | 1 | 8 |
| 2018 | 2 | — | 0 | 21 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 4 | 110 | 0 | 3 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 3 | 177 | 0 | 2 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 2 | — | 0 | 6 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Keeogo is robotic exoskeleton that fits orthotically on the user's waist, thigh, and shin, outside of clothing. The device is intended to help assist ambulatory function in rehabilitation settings under the supervision of a trained healthcare professional for the following population:
Individuals with stroke who have gait deficits and sufficient hip (MMT Hip > 3) and knee strength (MMT Knee > 2) and who are capable of standing and initiating gait movement without assistance.
The trained healthcare professional must successfully complete a training program prior to fitting and tuning the device. The device is not intended for sports.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201539 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201539: Keeogo Dermoskeleton System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201539
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026