ReWalk 7 Personal Exoskeleton (50-20-0005)
by Rewalk Robotics Ltd. Dba Lifeward
510(k) K241822
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK241822 | Date12 Mar 2025 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- PHL
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3480
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The ReWalk 7 Personal Exoskeleton (50-20-0005) is a powered exoskeleton designed to assist individuals with lower-limb paralysis or mobility impairments in standing, walking, and performing daily activities. Classified as a Powered Exoskeleton under the FDA’s nomenclature, it provides mechanical support and active motion to enhance functional independence for users with limited lower-body control.
This device is intended for home or clinical use and is supplied as a reusable system requiring assembly and calibration by trained personnel. It is not sterile and must be cleaned and maintained according to manufacturer instructions. The ReWalk 7 is approved under FDA 510(k) clearance and EU MDR, with regulatory classifications under device class II and product code PHL. Compliance with FDA regulation 890.3480 and specific FEI numbers (3015000676; 3018091330; etc.) governs its distribution and use.
Questions
AI-generated answers, 18 Sep 2026
What types of users is the ReWalk® 7 Personal Exoskeleton designed to assist, and how does it differ from other mobility aids?
The ReWalk® 7 is specifically designed for individuals with lower-limb paralysis or mobility impairments that limit their ability to stand or walk independently. Unlike traditional mobility aids like wheelchairs or canes, it provides powered mechanical support and active motion to assist with standing, walking, and daily activities. This makes it suitable for users who require functional independence but lack sufficient lower-body control to use passive mobility devices.
Is the ReWalk® 7 Personal Exoskeleton intended for single-use or reusable applications, and what maintenance is required?
The ReWalk® 7 is a reusable system and is not sterile. It requires assembly, calibration, and regular maintenance by trained personnel to ensure proper function. Users must follow the manufacturer’s cleaning and maintenance instructions to keep the device operational and safe for long-term home or clinical use.
How is the ReWalk® 7 Personal Exoskeleton regulated, and what does its classification under FDA 510(k) and EU MDR mean for buyers?
The ReWalk® 7 holds FDA 510(k) clearance and EU MDR compliance, classifying it as a Class II medical device under the FDA’s nomenclature (product code PHL). This means it has undergone rigorous review by the FDA’s Physical Medicine advisory committee and meets safety and performance standards for powered exoskeletons. Buyers can rely on its regulatory approvals for use in clinical and home settings, though local laws may still apply.
What regulatory route was followed for FDA clearance, and how does this impact its availability or distribution?
The ReWalk® 7 received traditional 510(k) clearance through the FDA’s Substantial Equivalence (SE) pathway, meaning it was compared to a legally marketed predicate device. This route ensures compliance with FDA regulation 890.3480 and requires adherence to specific FEI numbers (e.g., 3015000676) for distribution. While cleared, availability depends on local regulatory compliance and distribution agreements with authorized providers.