Home / 510(k) Clearances / K173530

510(k) K173530

Indego(R) by Parker-Hannifin Corporation — Product Code PHL

K173530 is an FDA 510(k) premarket notification submitted by Parker-Hannifin Corporation for the device "Indego(R)". The FDA issued a decision of Substantially Equivalent on Jan 31, 2018. 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
Jan 31, 2018
Date Received
Nov 15, 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
510(k)

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

  • K254198 — Trexo Theo (Sep 2, 2026)
  • K260381 — Eve (Aug 3, 2026)
  • K250904 — Atalante X (Oct 24, 2025)
  • K241822 — ReWalk® 7 Personal Exoskeleton (50-20-0005) (Mar 12, 2025)
  • K233695 — Medical HAL Lower Limb Type (HAL-ML) (May 7, 2024)
  • K232077 — Atalante X (Dec 13, 2023)
  • K221696 — ReWalk P6.0 (Mar 2, 2023)
  • K221859 — Atalante (Dec 29, 2022)
  • K220988 — EksoNR (Jun 9, 2022)
  • K213452 — GEMS-H (Apr 21, 2022)

FDA data resources