Identity
- Trade Name
- Ekso FDA UDI
- Generic Name
- Programmable ambulation exoskeleton, clinical FDA UDI
- Device Name
- The Ekso is a powered motorized orthosis. It consists of a fitted metal brace that supports the legs, feet, and torso. It is worn via straps on the body, legs, and feet. Battery powered motors drive knee and hip joints. It has an integrated solid torso containing the computer and power supply. It has a hand-held user interface to specify settings and initiate steps. The Ekso is used with a cane, crutch, or walker. FDA UDI
- Model / Reference
- GT FDA UDI
- Description
- The Ekso is a powered motorized orthosis. It consists of a fitted metal brace that supports the legs, feet, and torso. It is worn via straps on the body, legs, and feet. Battery powered motors drive knee and hip joints. It has an integrated solid torso containing the computer and power supply. It has a hand-held user interface to specify settings and initiate steps. The Ekso is used with a cane, crutch, or walker. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B1431200000 FDA UDI
- FDA Product Code
- PHL FDA UDI
- GMDN Term
- Programmable ambulation exoskeleton, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3480 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Programmable ambulation exoskeleton, clinical
Ekso by Ekso Bionics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ekso Bionics, Inc.
Sources (1)
- FDA UDI 38bba207-982a-43c0-bdc7-0bd4f74c9f87 33 fields · synced May 31, 2026