Cleared Traditional

K241822 - ReWalk 7 Personal Exoskeleton (50-20-0005)

K241822 is an FDA 510(k) clearance for ReWalk 7 Personal Exoskeleton (50-20-0005), manufactured by Rewalk Robotics Ltd. Dba Lifeward. The device is a Class 2 Neurology device with product code PHL cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K241822 · Rewalk Robotics Ltd. Dba Lifeward · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
261d
Days
Class 2
Risk

K241822 is an FDA 510(k) clearance for the ReWalk® 7 Personal Exoskeleton (50-20-0005). Classified as Powered Exoskeleton (product code PHL), Class II - Special Controls.

Submitted by Rewalk Robotics Ltd. Dba Lifeward (Yokneam Ilit, IL). The FDA issued a Cleared decision on March 12, 2025 after a review of 261 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.3480 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Rewalk Robotics Ltd. Dba Lifeward devices

FDA 510(k) Submission Details - K241822

510(k) Number K241822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2024
Decision Date March 12, 2025
Days to Decision 261 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 148d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PHL Device Classification - Class 2, Special Controls

Product Code PHL Powered Exoskeleton
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3480
Definition A Powered Exoskeleton Is A Prescription Device That Is Composed Of An External, Powered, Motorized Orthosis That Is Placed Over A Person's Paralyzed Or Weakened Lower Extremity Limb(s) For Medical Purposes.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - PHL Powered Exoskeleton

All 16
Devices cleared under the same product code (PHL) and FDA review panel - the closest regulatory comparables to K241822.
Atalante X
K250904 · Wandercraft SAS · Oct 2025
Medical HAL Lower Limb Type (HAL-ML)
K233695 · Cyberdyne, Inc. · May 2024
Atalante X
K232077 · Wandercraft SAS · Dec 2023
ReWalk P6.0
K221696 · Re Walk Robotics , Ltd. · Mar 2023
Atalante
K221859 · Wandercraft SAS · Dec 2022
EksoNR
K220988 · Ekso Bionics, Inc. · Jun 2022