Indego
FDA 510(k) K171334 · Parker Hannifin Corporation
510(k) numberK171334
Submission
- Device name
- Indego
- Applicant
- Parker Hannifin Corporation
Macedonia, OH, US - Received
- May 8, 2017
- Decision date
- September 8, 2017
- 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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|---|---|---|---|
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| 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 |
| K173530 | Indego(R)PHL · Traditional | 01/31/2018SE |
| 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 |
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Questions and answers
When was Indego cleared by the FDA?
Indego (K171334) received a 510(k) decision of Substantially Equivalent on September 8, 2017, 123 days after the submission was received.
What is the product code of K171334?
The FDA product code is PHL – Powered Exoskeleton, a Class II (moderate risk) device regulated under 21 CFR 890.3480.