Home / 510(k) Clearances / K200032

510(k) K200032

ReWalk P6.0 by Re Walk Robotics , Ltd. — Product Code PHL

K200032 is an FDA 510(k) premarket notification submitted by Re Walk Robotics , Ltd. for the device "ReWalk P6.0". The FDA issued a decision of Substantially Equivalent on May 26, 2020. The device falls under product code PHL (Powered Exoskeleton), a Class II device regulated under 21 CFR 890.3480. Re Walk Robotics , Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2020
Date Received
January 7, 2020
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 by Re Walk Robotics , Ltd.

  • K221696 — ReWalk P6.0 (March 2, 2023)
  • K190337 — ReWalk Restore (June 3, 2019)

Other clearances for product code PHL

  • K250904 — Atalante X (October 24, 2025)
  • K241822 — ReWalk® 7 Personal Exoskeleton (50-20-0005) (March 12, 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)

FDA data resources