Cleared Traditional

K241822 - ReWalk® 7 Personal Exoskeleton (50-20-0005) (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241822 · Rewalk Robotics Ltd. Dba Lifeward · Neurology device
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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

Submission Details

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.

Device Classification

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 23
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