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Complete Control System Gen2
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref N1
by Coapt, LLC
Identity
- Trade Name
- Complete Control System Gen2 EUDAMEDFDA UDI
- Generic Name
- Myoelectric hand prosthesis FDA UDI
- Device Name
- Complete Control System Gen2 EUDAMEDThe COMPLETE CONTROL System Gen2 is an advanced control solution designed to provide the functionality of a powered myoelectric prosthesis for upper extremity amputees. The COMPLETE CONTROL System Gen2 employs pattern recognition technology to non-invasively acquire user-specific muscle signals for the control of industry-standard upper extremity prostheses. FDA UDI
- Model / Reference
- N1 EUDAMED1 FDA UDI
- Description
- The COMPLETE CONTROL System Gen2 is an advanced control solution designed to provide the functionality of a powered myoelectric prosthesis for upper extremity amputees. The COMPLETE CONTROL System Gen2 employs pattern recognition technology to non-invasively acquire user-specific muscle signals for the control of industry-standard upper extremity prostheses. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B618N1 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B618N18Z EUDAMED
- 510(k) Number
- K191083 FDA UDI
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- Y061899,Z12100492 EUDAMED
- GMDN Term
- Myoelectric hand prosthesis FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Market of Registration
- Sweden 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
Complete Control System Gen2 by Coapt, LLC — 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
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 | K162891 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K191083 | Class I | Active |
| EUDAMED | European Union | CE/MDR | ++B618N18Z | Class I | Active |
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Manufacturer
- Manufacturer
- Coapt, LLC
- EUDAMED SRN
- US-MF-000003759
- Authorised Representative
- Fillauer Europe AB SE-AR-000002627
Sources (3)
- EUDAMED 039b649d-f0ed-41bf-9f1e-55d4e9865eb0 61 fields · synced Jun 19, 2026
- FDA UDI 4cc491e6-b964-4207-ab1e-fdc8e88a0c92 34 fields · synced May 30, 2026
- FDA 510(k) K162891 1 fields · synced May 18, 2026