Ekso (version 1.1) and Ekso GT (version 1.2)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K143690 FDA 510(k)
- FDA Product Code
- PHL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.3480 FDA 510(k)
- Regulation Number
- 890.3480 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Ekso (version 1.1) and Ekso GT (version 1.2) are powered exoskeletons designed to perform ambulatory functions in rehabilitation settings. These devices are intended for individuals with upper extremity motor function of at least 4/5 in both arms, including those with hemiplegia due to stroke and spinal cord injuries.
The Ekso devices are used under the supervision of trained physical therapists in rehabilitation institutions. They are classified as Class II medical devices with FDA 510(k) clearance (K143690) and regulation number 890.3480. The devices are supplied for institutional use and require professional oversight during operation.
Frequently asked questions
What is the intended use of Ekso and Ekso GT devices?
Ekso (version 1.1) and Ekso GT (version 1.2) are powered exoskeletons designed to perform ambulatory functions in rehabilitation settings. They are intended for individuals with upper extremity motor function of at least 4/5 in both arms, including those with hemiplegia due to stroke and spinal cord injuries.
How are Ekso devices classified and regulated?
The Ekso devices are classified as Class II medical devices with FDA 510(k) clearance (K143690) and regulation number 890.3480. They are supplied for institutional use and require professional oversight during operation under the supervision of trained physical therapists in rehabilitation institutions.
What is the difference between Ekso version 1.1 and Ekso GT version 1.2?
The device data provides information about both Ekso (version 1.1) and Ekso GT (version 1.2) as powered exoskeletons designed for rehabilitation settings. However, specific differences between these versions are not detailed in the provided information.
Who should use the Ekso devices and under what conditions?
Ekso devices are intended for individuals with upper extremity motor function of at least 4/5 in both arms, including those with hemiplegia due to stroke and spinal cord injuries. They are used under the supervision of trained physical therapists in rehabilitation institutions and are supplied for institutional use only.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Ekso™ (version 1.1) and Ekso GT™ (version 1.2) - fda.innolitics.com, PDF DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and ..., Ekso™ (version 1.1) And Ekso GT™ (version 1.2)… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K143690 | Class II | Active |
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Manufacturer
- Manufacturer
- Ekso Bionics, Inc.
Sources (1)
- FDA 510(k) K143690 24 fields · synced Oct 1, 2026