Identity
- Trade Name
- Kinesia One FDA UDI
- Generic Name
- Tremor transducer FDA UDI
- Device Name
- Kinesia One, Tablet Assembly, WiFi plus Cellular FDA UDI
- Model / Reference
- 502-0270, Tablet Assembly, WiFi plus Cellular FDA UDI
- Description
- Kinesia One, Tablet Assembly, WiFi plus Cellular FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859584006041 FDA UDI
- 510(k) Number
- K063872 FDA UDI
- FDA Product Code
- GYD FDA UDI
- GMDN Term
- Tremor transducer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1950 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: Tremor transducer
Kinesia One by Great Lakes NeuroTechnologies Inc — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Tremor transducer.
- Parky — H2O BILISIM YAZILIM ELEKTRONIK SAGLIK HIZMETLERI SANAYI VE TICARET LIMITED SIRKETI · Class II
- Kinesia 360 — Great Lakes NeuroTechnologies Inc · Class II
- Kinesia 360 — Great Lakes NeuroTechnologies Inc · Class II
- Kinesia One — Great Lakes NeuroTechnologies Inc · Class II
- Kinesia StimPoint — Great Lakes NeuroTechnologies Inc · Class II
- Kinesia StimPoint — Great Lakes NeuroTechnologies Inc · Class II
- Kinesia StimPoint — Great Lakes NeuroTechnologies Inc · Class II
- Kinesia — Great Lakes NeuroTechnologies Inc · Class II
Cleared under the same submission
K063872 also covers:
- Kinesia — Great Lakes NeuroTechnologies Inc
- Kinesia — Great Lakes NeuroTechnologies Inc
- Kinesia — Great Lakes NeuroTechnologies Inc
- Kinesia — Great Lakes NeuroTechnologies Inc
- Kinesia 360 — Great Lakes NeuroTechnologies Inc
- Kinesia 360 — Great Lakes NeuroTechnologies Inc
- Kinesia 360 — Great Lakes NeuroTechnologies Inc
- Kinesia 360 — Great Lakes NeuroTechnologies Inc
- Kinesia 360 — Great Lakes NeuroTechnologies Inc
- Kinesia 360 — Great Lakes NeuroTechnologies Inc
- Kinesia 360 — Great Lakes NeuroTechnologies Inc
- Kinesia One — Great Lakes NeuroTechnologies Inc
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Great Lakes NeuroTechnologies Inc
Sources (2)
- FDA UDI 73f25910-d0d9-48a4-b6be-fc1eb3dc48f0 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026