510(k) · Cleared
ClearedReWalk® 7 Personal Exoskeleton (50-20-0005)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rewalk Robotics Ltd. Dba Lifeward · PHL Powered Exoskeleton
Cleared on Mar 12, 2025 as substantially equivalent to K221696 (Re Walk Robotics, Ltd., 2023) after a 261-day review. Its family tree reaches back 3 generations to 2016.
- Decided
- Mar 12, 2025
- Review
- 261 days
- Class
- Class II
- Product code
- PHL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K160987 (2016). No later device cites it as a predicate yet.
- Root · 3 generations backK160987 ReWalk (TM)Rewalk Robotics, Inc. · 2016 · Recalled
- 2 generations backK200032 ReWalk P6.0Re Walk Robotics, Ltd. · 2020 · Recalled
- 1 generation backK221696 ReWalk P6.0Re Walk Robotics, Ltd. · 2023
- This deviceK241822 ReWalk® 7 Personal Exoskeleton (50-20-0005)Rewalk Robotics Ltd. Dba Lifeward · 2025
View FIG. 1 as a table
Line of descent and top descendants
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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K221696 | ReWalk P6.0Summary page 6…rison 21 CFR 807.92(a)(6) This traditional 510(k) submission introduces the ReWalk 7 personal exoskeleton, an enhanced version of its predicate device, the ReWalk P6.0 (K221696). The ReWalk 7 is identical to the predicate device in terms of intended use, contraindications, indications for use, indications… | 2023 |
| Kept off the family tree | K160987 | FDA’s K160987 is ReWalk (TM) Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2016 |
| * | — | ReWalk® P6.0 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.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K221696.
How does its category compare?
All PHL devicesPHL Powered Exoskeleton: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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® 7 Personal Exoskeleton 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 in home and community settings with supervision of a specially certified 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…
Read the full statement (118 words)
The ReWalk® 7 Personal Exoskeleton 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 in home and community settings with supervision of a specially certified 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 7 is intended for indoor and outdoor use: including standing and walking on level
surfaces and mild slopes, and ascending and descending stairs and curbs.
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/K241822 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241822: ReWalk® 7 Personal Exoskeleton (50-20-0005).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241822
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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