Home / 510(k) Clearances / K171909

510(k) K171909

HAL for Medical Use (Lower Limb Type) by Cyberdyne, Inc. — Product Code PHL

K171909 is an FDA 510(k) premarket notification submitted by Cyberdyne, Inc. for the device "HAL for Medical Use (Lower Limb Type)". The FDA issued a decision of Substantially Equivalent on December 17, 2017. The device falls under product code PHL (Powered Exoskeleton), a Class II device regulated under 21 CFR 890.3480. Cyberdyne, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2017
Date Received
June 26, 2017
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 Cyberdyne, Inc.

  • K233695 — Medical HAL Lower Limb Type (HAL-ML) (May 7, 2024)
  • K201559 — HAL for Medical Use(Lower Limb type) (October 2, 2020)

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