510(k) · Cleared
Recalled · Class II · 2020ReWalk (TM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rewalk Robotics, Inc. · PHL Powered Exoskeleton
Cleared on Jul 22, 2016 after a 105-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 22, 2016
- Review
- 105 days
- Class
- Class II
- Product code
- PHL
- Recalls
- 2
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK160987 ReWalk (TM)Rewalk Robotics, Inc. · 2016
- Descendant · cites it directly · 3 of its ownK200032 ReWalk P6.0Re Walk Robotics, Ltd. · 2020 · Recalled
- Descendant · 2 generations on · 2 of its ownK221696 ReWalk P6.0Re Walk Robotics, Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK254198 Trexo TheoTrexo Robotics, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK241822 ReWalk® 7 Personal Exoskeleton (50-20-0005)Rewalk Robotics Ltd. Dba Lifeward · 2025
Most influential descendants
Showing 4 of 4 · See all- K200032ReWalk P6.0Re Walk Robotics, Ltd. · 2020 · cites it directly3descendants
- K221696ReWalk P6.0Re Walk Robotics, Ltd. · 2023 · 2 generations on2descendants
- K254198Trexo TheoTrexo Robotics, Inc. · 2026 · 3 generations on0descendants
- K241822ReWalk® 7 Personal Exoskeleton (50-20-0005)Rewalk Robotics Ltd. Dba Lifeward · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K160987 | ReWalk (TM) | Rewalk Robotics, Inc. | 2016 | — |
| +1 | K200032 | ReWalk P6.0 | Re Walk Robotics, Ltd. | 2020 | 1 |
| +2 | K221696 | ReWalk P6.0 | Re Walk Robotics, Ltd. | 2023 | — |
| +3 | K254198 | Trexo Theo | Trexo Robotics, Inc. | 2026 | — |
| +3 | K241822 | ReWalk® 7 Personal Exoskeleton (50-20-0005) | Rewalk Robotics Ltd. Dba Lifeward | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200032 | ReWalk P6.0 | 2020 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 28, 2020 | Class II | Z-1553-2021 | Device Design | ReWalk Robotics received two complaints (one in the US; one in the Germany), which alleged that the ReWalk device waistpack (which is the location of the Li-Ion battery packs) caught fire while being charged. |
| Aug 14, 2017 | Class II | Z-0944-2018 | Other | Firm received complaints for ReWalk Personal 6.0 of an injury to tibia and fibula. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K200032 (Re Walk Robotics, Ltd., 2020) has gone furthest, with 3 descendants of its own.
How does its category compare?
All PHL devicesPHL Powered Exoskeleton: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 ReWalk™ orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions with supervision of a specially trained companion in accordance with the user assessment and training certification program. The device is also intended to enable individuals with spinal cord injury at levels T4 to T6 to perform ambulatory functions in rehabilitation institutions in accordance with the user assessment and training certification program. The ReWalk™ is not intended for sports or stair climbing.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K160987 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160987: ReWalk (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160987
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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