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510(k) K241822

ReWalk® 7 Personal Exoskeleton (50-20-0005) by Rewalk Robotics Ltd. Dba Lifeward — Product Code PHL

K241822 is an FDA 510(k) premarket notification submitted by Rewalk Robotics Ltd. Dba Lifeward for the device "ReWalk® 7 Personal Exoskeleton (50-20-0005)". The FDA issued a decision of Substantially Equivalent on March 12, 2025. The device falls under product code PHL (Powered Exoskeleton), a Class II device regulated under 21 CFR 890.3480.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2025
Date Received
June 24, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powered Exoskeleton
Device Class
Class II
Regulation Number
890.3480
Review Panel
NE
Submission Type

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.

Other clearances for product code PHL

  • K250904 — Atalante X (October 24, 2025)
  • K233695 — Medical HAL Lower Limb Type (HAL-ML) (May 7, 2024)
  • K232077 — Atalante X (December 13, 2023)
  • K221696 — ReWalk P6.0 (March 2, 2023)
  • K221859 — Atalante (December 29, 2022)
  • K220988 — EksoNR (June 9, 2022)
  • K213452 — GEMS-H (April 21, 2022)
  • K201473 — ExoAtlet-II (July 16, 2021)
  • K201559 — HAL for Medical Use(Lower Limb type) (October 2, 2020)
  • K201539 — Keeogo Dermoskeleton System (September 9, 2020)

FDA data resources