Indego(R)
FDA 510(k) K173530 · Parker-Hannifin Corporation
510(k) numberK173530
Submission
- Device name
- Indego(R)
- Applicant
- Parker-Hannifin Corporation
Macedonia, OH, US - Received
- November 15, 2017
- Decision date
- January 31, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PHL – Powered Exoskeleton
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3480
- Specialty
- Physical Medicine
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.
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|---|---|---|---|
| K254198 | Trexo TheoPHL · Traditional | Trexo Robotics, Inc. | 09/02/2026SE |
| K260381 | EvePHL · Traditional | Wandercraft SAS | 08/03/2026SE |
| K250904 | Atalante XPHL · Traditional | Wandercraft SAS | 10/24/2025SE |
| K241822 | ReWalk® 7 Personal Exoskeleton (50-20-0005)PHL · Traditional | Rewalk Robotics Ltd. Dba Lifeward | 03/12/2025SE |
| K233695 | Medical HAL Lower Limb Type (HAL-ML)PHL · Traditional | Cyberdyne, Inc. | 05/07/2024SE |
| K232077 | Atalante XPHL · Traditional | Wandercraft SAS | 12/13/2023SE |
| K221696 | ReWalk P6.0PHL · Traditional | Re Walk Robotics , Ltd. | 03/02/2023SE |
| K221859 | AtalantePHL · Traditional | Wandercraft SAS | 12/29/2022SE |
| K220988 | EksoNRPHL · Traditional | Ekso Bionics, Inc. | 06/09/2022SE |
| K213452 | Gems-HPHL · Traditional | Samsung Electronics Co., Ltd. | 04/21/2022SE |
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| K202480 | Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50BZR · Traditional | 04/22/2021SE |
| K171334 | IndegoPHL · Traditional | 09/08/2017SE |
| K161731 | Cleveland Multiport Ventricular Catheter SetHCA · Traditional | 03/27/2017SE |
| K152416 | IndegoPHL · Traditional | 02/26/2016SE |
| K897086 | Parker Ambulatory Medication Infusion Pump 2004FRN · Traditional | 09/28/1990SE |
| K863532 | Modified Labeling to Model 2000 Ambulatory InfuserFRN · Traditional | 01/14/1987SE |
| K834461 | Infusion Pump PrimerFRN · Traditional | 01/30/1984SE |
| K833723 | Model 2000 Ambulatory Med. InfuserFRN · Traditional | 01/30/1984SE |
Questions and answers
When was Indego(R) cleared by the FDA?
Indego(R) (K173530) received a 510(k) decision of Substantially Equivalent on January 31, 2018, 77 days after the submission was received.
What is the product code of K173530?
The FDA product code is PHL – Powered Exoskeleton, a Class II (moderate risk) device regulated under 21 CFR 890.3480.