Identity
- Trade Name
- Kinesia One FDA UDI
- Generic Name
- Tremor transducer FDA UDI
- Device Name
- Kinesia ONE EUDAMEDKinesia One System, WiFi FDA UDI
- Model / Reference
- Kinesia ONE 700-0019 EUDAMED700-0019, WiFi FDA UDI
- Description
- Kinesia One System, WiFi FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859584006003 EUDAMEDFDA UDI
- Basic UDI-DI
- 0859584006KinesiaWG EUDAMED
- Direct Marketing DI
- 00859584006003 EUDAMED
- 510(k) Number
- K063872 FDA UDI
- FDA Product Code
- GYD FDA UDI
- EMDN Code
- W01010899 MULTIPLE PARAMETER - ELECTRODES/BIOSENSORS - OTHER EUDAMED
- GMDN Term
- Tremor transducer FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1950 FDA UDI
- Market of Registration
- Bulgaria 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
Kinesia ONE by Great Lakes NeuroTechnologies Inc — Class I — 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 | 0859584006KinesiaWG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Great Lakes NeuroTechnologies Inc
- EUDAMED SRN
- US-MF-000031444
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (2)
- EUDAMED 345484ea-fb90-41b6-8f90-2d7c58ce55b2 61 fields · synced May 29, 2026
- FDA UDI 61399f43-5435-46ce-bdec-ed9671d146f1 35 fields · synced May 29, 2026