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EksoNR
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 900001-1Model EKSONR510(k) K220988
Identity
- Trade Name
- EksoNR EUDAMEDFDA UDI
- Generic Name
- Programmable ambulation exoskeleton, clinical FDA UDI
- Device Name
- EksoNR EUDAMEDEKSO BIONICS SYSTEM, Ekso NR FDA UDI
- Model / Reference
- EKSONR EUDAMEDFDA UDI900001-1 EUDAMED
- Description
- EKSO BIONICS SYSTEM, Ekso NR FDA UDI
Identifiers
- Catalog Number
- EKSONR FDA UDI
- Primary DI / UDI-DI
- B168EKSONR0 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B168EKSONRZM EUDAMED
- 510(k) Number
- K200574 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
- Germany 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
No
FDA UDI
EksoNR by Ekso Bionics, Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200574 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K220988 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++B168EKSONRZM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ekso Bionics, Inc.
- EUDAMED SRN
- US-MF-000024649
- Authorised Representative
- QAdvis EAR AB SE-AR-000001599
Sources (3)
- EUDAMED 62988cf8-8994-415b-9462-30c7605b7db4 85 fields · synced Jun 18, 2026
- FDA UDI bb2be74d-eb3b-4b50-a82f-7a5247bfaa81 35 fields · synced May 30, 2026
- FDA 510(k) K200574 1 fields · synced May 18, 2026