Identity
- Trade Name
- Indego EUDAMEDFDA UDI
- Generic Name
- Programmable ambulation exoskeleton, clinical FDA UDI
- Device Name
- Indego EUDAMEDIndego is a computerized, powered exoskeleton, designed to restore walking function for impaired individuals. FDA UDI
- Model / Reference
- 501-100-000 EUDAMEDFDA UDI
- Description
- Indego is a computerized, powered exoskeleton, designed to restore walking function for impaired individuals. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B168501100000 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B16850110000028 EUDAMED
- Direct Marketing DI
- B168501100000 EUDAMED
- 510(k) Number
- K152416 FDA UDI
- FDA Product Code
- PHL FDA UDI
- EMDN Code
- Y061299 LOWER EXTREMITY ORTHOSES - OTHER EUDAMED
- GMDN Term
- Programmable ambulation exoskeleton, clinical FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 890.3480 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
MR Unsafe FDA UDI
Indego by Ekso Bionics, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++B16850110000028 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Ekso Bionics, Inc.
- EUDAMED SRN
- US-MF-000024649
- Authorised Representative
- QAdvis EAR AB SE-AR-000001599
Sources (2)
- EUDAMED 114d9636-bfb4-4c5b-a66b-b3e20b0bc66b 61 fields · synced Jun 18, 2026
- FDA UDI c6ecd963-bbf3-4045-9107-d52505f9ff2f 36 fields · synced May 29, 2026