510(k) · Cleared
ClearedReWalk P6.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Re Walk Robotics, Ltd. · PHL Powered Exoskeleton
Cleared on Mar 2, 2023 as substantially equivalent to K200032 (Re Walk Robotics, Ltd., 2020) after a 265-day review. Its family tree reaches back 2 generations to 2016. 2 later devices descend from it.
- Decided
- Mar 2, 2023
- Review
- 265 days
- Class
- Class II
- Product code
- PHL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K160987 (2016). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK160987 ReWalk (TM)Rewalk Robotics, Inc. · 2016 · Recalled
- 1 generation backK200032 ReWalk P6.0Re Walk Robotics, Ltd. · 2020 · Recalled
- This deviceK221696 ReWalk P6.0Re Walk Robotics, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK254198 Trexo TheoTrexo Robotics, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK241822 ReWalk® 7 Personal Exoskeleton (50-20-0005)Rewalk Robotics Ltd. Dba Lifeward · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K160987 | ReWalk (TM) | Rewalk Robotics, Inc. | 2016 | 2 |
| −1 | K200032 | ReWalk P6.0 | Re Walk Robotics, Ltd. | 2020 | 1 |
| 0 (this device) | K221696 | ReWalk P6.0 | Re Walk Robotics, Ltd. | 2023 | — |
| +1 | K254198 | Trexo Theo | Trexo Robotics, Inc. | 2026 | — |
| +1 | 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 |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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 |
|---|---|---|---|
| * | K200032 | ReWalk P6.0Summary page 5…Marketed Predicate Device Predicate Manufacturer: ReWalk Robotics Ltd. Predicate Trade Name: ReWalk P6.0 Predicate 510(k): K200032 6. Legally Marketed Reference Device Reference Device Manufacturer: ReWalk Robotics Ltd. Reference Device Trade Name… | 2020 |
| † | K160987 | ReWalk (TM) | 2016 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K254198 (Trexo Robotics, Inc., 2026) has gone furthest, with 0 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. 2023, 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® P6.0 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…
Read the full statement (116 words)
The ReWalk® P6.0 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 P6.0 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/K221696 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221696: ReWalk P6.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221696
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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