Gen2 System Kit - The Gen2 System Kit is a medical device kit that contains the Coapt COMPLETE CONTROL System Gen2 (DI=B618N1) and the Coapt Dome Electrodes (DI=B618E0).
2019-06-19
Coapt LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010605876 | 3010605876 | Coapt LLC | 1 | N | 2026-01-01 | 303 W. Institute Pl. Suite 200 Chicago IL US 60610 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 164499 | 1244943277 | K223605 | ControlSeal Electrode (ELSB) | GXY | 2022-12-30 |
| 164499 | 1505526475 | K191083 | COMPLETE CONTROL System Gen2 | GXY | 2019-05-24 |
| 164499 | 1876426838 | K190416 | Dome Electrode | GXY | 2019-04-04 |
| 164499 | 1215220765 | K162891 | Complete Control System | GXY | 2017-04-14 |
| 164499 | 1035453081 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GXY | 4 | 2022-12-30 |
GUDID#
COMPLETE CONTROL System Gen2 - 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.
2019-06-12
Complete Controller - Pattern Recognition Processing Unit
2018-05-08
Complete Communicator - PC-Side Wireless Radio Receiver Unit
2018-05-08
Complete Co-Amp - 8-Channel EMG Front End Processing Unit
2018-05-08
Complete Calibrate - Socket-Mount Calibration Unit
2018-05-08
ControlSeal Electrode Domes (Standard Size) - Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG).
2023-01-09
ControlSeal Electrode Domes (Standard Size) - Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG).
2023-01-09
ControlSeal Electrode Domes (Standard Size) - Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG).
2023-02-20
ControlSeal Electrode Domes (Large Size) - Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG).
2023-02-20
ControlSeal Electrode Domes (Standard Size) - Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG).
2023-01-09
ControlSeal Electrode Domes (Large Size) - Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG).
2023-01-09
Dome Electrodes - Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG).
2019-04-15
ControlSeal Electrode Domes (Standard Size) - Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG).
2023-02-20
ControlSeal Electrode Domes (Large Size) - Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG).
2023-02-20
Coapt Evaluation Kit - The Coapt Evaluation Kit is a handheld clinical tool created with technology from the Coapt COMPLETE CONTROL System Gen2. It is an accessory intended to be used during the planning and alignment of myoelectric control contact locations for an upper limb prosthetic socket.
2019-11-18