Class Class II
ReWalk P6.0 (K221696)
Description
ReWalk P6.0 by Re Walk Robotics , Ltd., an FDA 510(k) cleared physical medicine device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221696
Clearance Date2023-03-02
Clearance TypeTraditional
Product CodePHL
Regulation Number890.3480
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221696
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. ReWalk P6.0 (K221696) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200032 | ReWalk P6.0 | Re Walk Robotics , Ltd. | 2020 |
| K160987 | ReWalk(TM) | Rewalk Robotics, Inc. | 2016 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241822 | ReWalk® 7 Personal Exoskeleton (50-20-0005) | Rewalk Robotics Ltd. Dba Lifeward | 2025 |
Trace the full predicate network for K221696
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.