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510(k) DEN130034

REWALK by Argo Medical Technologies, Inc. — Product Code PHL

DEN130034 is an FDA 510(k) premarket notification submitted by Argo Medical Technologies, Inc. for the device "REWALK". The FDA issued a decision of De Novo Granted on June 26, 2014. The device falls under product code PHL (Powered Exoskeleton), a Class II device regulated under 21 CFR 890.3480.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
June 26, 2014
Date Received
June 17, 2013
Clearance Type
Direct
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

  • 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)
  • 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)

FDA data resources