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KneeKG-Exoskeleton
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 080
by Emovi inc.
Identity
- Trade Name
- KneeKG-Exoskeleton FDA UDI
- Generic Name
- Gait analysis system FDA UDI
- Device Name
- KneeKG-Exoskeleton EUDAMED
- Model / Reference
- 080 EUDAMED0 FDA UDI
Identifiers
- Catalog Number
- P-080 FDA UDI
- Primary DI / UDI-DI
- 00627843933243 EUDAMEDFDA UDI
- Basic UDI-DI
- 627843933243080RH EUDAMED
- Direct Marketing DI
- 00627843933243 EUDAMED
- EMDN Code
- Z12062580 KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Gait analysis system FDA UDI
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
KneeKG-Exoskeleton by Emovi Inc — Class I — 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
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K091000 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 627843933243080RH | Class I | Active |
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Manufacturer
- Manufacturer
- Emovi inc.
- EUDAMED SRN
- CA-MF-000023167
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (3)
- EUDAMED 0ba834fc-b3dd-4c00-a653-28fcabe1cb28 61 fields · synced Aug 4, 2026
- FDA UDI 702b1a4b-92bb-4ba1-84ff-be384c0ac3af 33 fields · synced May 30, 2026
- FDA 510(k) K091000 1 fields · synced May 18, 2026