COAPT LLC

Address:303 W. Institute Pl.,Chicago,IL,60610,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Electrode, Cutaneous (GXY) (7) Device, Prosthesis Alignment (IQO) (1)

Premarket Exempt

No Yes

Clear

Complete Controller - B618A0 Catalog Number : CC110

Device Description : Pattern Recognition Processing Unit

Device Class : 2

Duns Number: 078505297

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Complete Communicator - B618B0 Catalog Number :

Device Description : PC-Side Wireless Radio Receiver Unit

Device Class : 2

Duns Number: 078505297

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Complete Co-Amp - B618C0 Catalog Number :

Device Description : 8-Channel EMG Front End Processing Unit

Device Class : 2

Duns Number: 078505297

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Complete Calibrate - B618D0 Catalog Number :

Device Description : Socket-Mount Calibration Unit

Device Class : 2

Duns Number: 078505297

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Dome Electrodes - B618E0 Catalog Number :

Device Description : Non-invasive, cutaneous electrode for use with recording and monitoring equipmen Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG).

Device Class :

Duns Number: 078505297

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 18

COMPLETE CONTROL System Gen2 - B618N1 Catalog Number :

Device Description : The COMPLETE CONTROL System Gen2 is an advanced control solution designed to pro 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.

Device Class : 2

Duns Number: 078505297

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Gen2 System Kit - B618P1 Catalog Number :

Device Description : The Gen2 System Kit is a medical device kit that contains the Coapt COMPLETE CON 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).

Device Class : 2

Duns Number: 078505297

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Coapt Evaluation Kit - B618Q1 Catalog Number :

Device Description : The Coapt Evaluation Kit is a handheld clinical tool created with technology fro 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.

Device Class : 1

Duns Number: 078505297

Premarket Exempt : Yes

Product Code : IQO

Prescription Use : No

Device Count : 1

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