Indego Exoskeleton
by Parker-Hannifin Corporation
510(k) K173530
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK173530 | Date31 Jan 2018 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Indego(R)
- 510(k) Number
- FDA Product Code
- PHL
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3480
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Indego is a Powered Exoskeleton, classified under FDA device code PHL, designed to assist individuals with lower-limb mobility impairments. It provides active support for walking, standing, and balance through motorised joints and sensors, enabling greater independence in daily activities. The device is intended for use in physical medicine and rehabilitation settings, supporting patients with conditions such as spinal cord injuries or stroke-related paralysis. Its structure includes modular components for customisation to individual user requirements, including weight and range of motion adjustments.
The Indego is supplied as a reusable, non-sterile medical device, intended for use in clinical or home environments under professional supervision. It requires calibration and maintenance by trained personnel to ensure proper function and safety. The exoskeleton is not MRI-compatible and must be removed before MRI procedures. Sizes and configurations are tailored to specific user measurements, with adjustments made via the manufacturer’s software interface. FDA clearance under 510(k) number K173530 confirms its regulatory compliance for powered exoskeletons in physical medicine applications.
Other devices from Parker Hannifin Corp.
Questions
AI-generated answers, 1 Oct 2026
What conditions is the Indego exoskeleton designed to assist with?
The Indego is specifically engineered to support individuals with lower-limb mobility impairments, such as those resulting from spinal cord injuries or stroke-related paralysis. Its motorised joints and sensors provide active assistance for walking, standing, and maintaining balance, helping users regain independence in daily activities within clinical or home settings under professional supervision.
Is the Indego exoskeleton reusable or single-use?
The Indego is a reusable medical device, not intended for single-use. It is designed for long-term clinical or home use, provided it undergoes regular calibration and maintenance by trained personnel to ensure safety and optimal function. This approach aligns with its intended application in physical medicine and rehabilitation settings.
How is the Indego customised to fit individual users?
The Indego features modular components that allow adjustments to weight and range of motion, tailored to each user’s specific measurements. Customisation is managed through the manufacturer’s proprietary software interface, enabling precise calibration of the exoskeleton’s performance for optimal support and comfort.
Can the Indego be used during MRI procedures?
No, the Indego is not MRI-compatible. Users must remove the device before undergoing MRI scans to avoid potential interference or safety risks. This restriction is clearly documented in the device’s operational guidelines to ensure patient safety.
What regulatory approval does the Indego hold?
The Indego has received FDA clearance under the 510(k) pathway, with clearance number K173530. This approval confirms its substantial equivalence to a predicate device and compliance for use as a powered exoskeleton in physical medicine applications, as classified under FDA device code PHL.