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510(k) Data Aggregation
K Number
K173530Device Name
Indego(R)
Manufacturer
Parker-Hannifin Corporation
Date Cleared
2018-01-31
(77 days)
Product Code
PHL
Regulation Number
890.3480Why did this record match?
Applicant Name (Manufacturer) :
Parker-Hannifin Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Indego® orthotically fits to the lower limbs and the trunk; the device is intended to enable individuals with spinal cord injury at levels T3 to L5 to perform ambulatory functions with supervision of a specially trained companion in accordance with the user assessment and training certification program. The device is also intended to enable individuals with spinal cord injury at levels C7 to L5 to perform ambulatory functions in rehabilitations in accordance with the user assessment and training certification program. Finally, the Indego® is also intended to enable individuals with hemiplegia (with motor function of 4/5 in at least one upper extremity) due to cerebrovascular accident (CVA) to perform ambulatory functions in rehabilitations in accordance with the user assessment and training certification program. The Indego is not intended for sports or stair climbing.
Device Description
Parker Hannifin's Indego® device is a wearable powered exoskeleton that actively assists individuals to stand and walk; these are patients with walking impairments resulting from lower extremity weakness or paralysis. The Indego consists of snap-together components weighing 26 pounds total. The hip component houses a rechargeable battery pack, central processor, and Bluetooth radio, while each upper leg component houses two motors as well as embedded sensors and controllers.
In the original operational mode of the device, called Motion+, on-board microprocessors receive signals from integrated sensors which provide information on the user's posture and tilt. This allows the device to function in a manner similar to the Segway personal mobility device, which is controlled by the user's tilt. A user similarly controls the motions of the Indego by means of postural changes (e.g., to walk forward, the user just leans forward). Alternatively, the device can be placed in a second operating mode, referred to as Therapy+, in which the device responds to the motion of users who are able to initiate stepping on their own. When operating in Therapy+, the user walks normally while the system detects step initiation and assists the user. Therapy+ may be used only in a clinical setting under clinical supervision. The technology of the design links the low profile to advanced battery technology (smaller size), motors (smaller and more powerful), and micro controllers (state-of-the art). Visual cues from the LED lights on the hip and vibratory feedback inform both the patient and therapist or trained support person of the status and mode of operation.
The Indego controls are self-contained, with crutches or a walker used solely for stability. Users can perform sit-to-stand and stand-to-sit transitions and walk along even or uneven terrain up to about five degree (5°) grades. Tall hip wings and a tall torso pad are provided to support users who may need additional trunk support while walking. A physical therapist can configure, operate, and monitor the device during therapy and training to make adjustments as needed. This is achieved through the support of a wireless application that will run on mobile/wifi connected smart devices such as an iPod or iPhone. The patient and physical therapist will be able to work in concert to actions of transitioning from sitting to standing to walking, stop walking, and return from standing to sitting. The untethered, free-roaming design of the device allows it to be utilized in multiple indoor and outdoor locations within a rehabilitation or personal setting.
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