Identity
- Trade Name
- Kinesia 360 FDA UDI
- Generic Name
- Tremor transducer FDA UDI
- Device Name
- Kinesia 360 Flex system is intended to monitor physical motion and muscle activity to quantify kinematics of movement disorder symptoms and assess activity in any instance where quantifiable analysis of motion and muscle activity is desired. FDA UDI
- Model / Reference
- 700-0020-3 K360 Flex FDA UDI
- Description
- Kinesia 360 Flex system is intended to monitor physical motion and muscle activity to quantify kinematics of movement disorder symptoms and assess activity in any instance where quantifiable analysis of motion and muscle activity is desired. FDA UDI
Identifiers
- Catalog Number
- 700-0020-3 FDA UDI
- Primary DI / UDI-DI
- 00859584006270 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 360 by Great Lakes NeuroTechnologies Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 One — Great Lakes NeuroTechnologies Inc
- Kinesia One — Great Lakes NeuroTechnologies Inc
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Great Lakes NeuroTechnologies Inc
Sources (1)
- FDA UDI f4cacbb2-e1fa-428b-8d93-5abdcd0ead8c 35 fields · synced May 30, 2026