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510(k) K221696

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

K221696 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 March 2, 2023. 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
March 2, 2023
Date Received
June 10, 2022
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.

  • K200032 — ReWalk P6.0 (May 26, 2020)
  • K190337 — ReWalk Restore (June 3, 2019)

Other clearances for product code PHL

  • K260381 — Eve (August 3, 2026)
  • 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)
  • 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