List the main differences between Keeogo and its predicate device?

Search all FDA released documents on past 510(k) approvals to determine information on predicates.

Challenge

Searching through FDA's 510(K) database allows you to search through specific fields but what if you want to search for information within published approval letters and summaries.

Features Used

Method

Using the Cedience platform first identify the 510K exoskeleton approvals with a simple keyword search. Then enter your question about these products

In this case the question asked was,

What are the main differences between keeogo and its predicate device?

Findings

Here's the answer Cedience's intelligent search returns:

The Keeogo Dermoskeleton System fits orthotically on the user's waist, thigh, and shin, while the Honda Walking Assist Device fits orthotically on the user's waist and thigh.

The Keeogo system defines the necessary physical characteristics of the patient population in terms of minimum hip and knee strength, while the Honda system describes the patient characteristics in terms of minimum gait speed.

The Keeogo system is intended to assist ambulatory function in rehabilitation settings under the supervision of a trained healthcare professional for individuals with stroke who have gait deficits and sufficient hip and knee strength. The Honda system is intended to assist ambulatory function in rehabilitation institutes under the supervision of a trained healthcare professional for 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.

Both devices require the healthcare professional to complete a training program prior to use, and neither device is intended for sports.