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510(k) Data Aggregation
K Number
K181294Device Name
Honda Walking Assist Device
Manufacturer
Honda Motor Company, Ltd.
Date Cleared
2018-12-14
(212 days)
Product Code
PHL
Regulation Number
890.3480Why did this record match?
Applicant Name (Manufacturer) :
Honda Motor Company, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Honda Walking Assist Device is a robotic exoskeleton that fits orthotically on the user's waist and thigh, outside of clothing. The device is intended to help assist ambulatory function in rehabilitation institutes under the supervision of a trained healthcare professional for the following population:
- Individuals with stroke who have gait deficits and exhibit gait speeds of at least 0.4m/s and are able to walk at least 10 meters with assistance from a maximum of one person.
The trained healthcare professional must successfully complete a training program prior to use of the device. The devices are not intended for sports.
Device Description
The Honda Walking Assist Device is a lightweight, robotic exoskeleton designed to help assist ambulatory function of stoke patients who meet the user assessment criteria, in rehabilitation institutes under the supervision of a trained healthcare professional. The device is worn around the user's waist and thighs, and assists with hip ioint flexion and extension. The device weighs 5.95lbs and has two motors that run on a single rechargeable battery. The device is equipped with angle and current sensors to monitor hip joint angle and torque output respectively. The assist torque is transmitted to the user's thighs via thigh frames. A trained healthcare professional, who operates the device, can change assist settings through software that runs on a mobile device.
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