FDA.reportPublic FDA data

Coapt Evaluation Kit

Primary DI
B618Q1
Brand
Coapt Evaluation Kit
Company
COAPT LLC
Model
1
Device description
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.
Published
2019-11-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IQODevice, Prosthesis Alignment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQODevice, Prosthesis AlignmentPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B618Q1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bioelectrical signal analysis softwareA software program intended to acquire, process, store and analyse biological electrical signals, both in real-time and delayed time, for diagnostic applications. The signals are typically provided by electrophysiological recording/monitoring [e.g., electromyography (EMG), electroencephalography (EEG), evoked potentials (EP), bioelectrical impedance analysis (BIA)]. It may be installed in the recording/monitoring device, personal computer, or data network server. It is neither intended for continuous bedside nor intraoperative monitoring, and is not dedicated to hearing analysis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078505297
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B618P1Gen2 System Kit12019-06-19
B618N1COMPLETE CONTROL System Gen212019-06-12
B618A0Complete Controller 1CC1102018-05-08
B618B0Complete Communicator 12018-05-08
B618C0Complete Co-Amp 12018-05-08
B618D0Complete Calibrate 12018-05-08
B618E1ControlSeal Electrode Domes (Standard Size)12023-01-09
B618E2ControlSeal Electrode Domes (Standard Size)12023-01-09
B618E4ControlSeal Electrode Domes (Standard Size)12023-02-20
B618E5ControlSeal Electrode Domes (Large Size)12023-02-20
E10001ControlSeal Electrode Domes (Standard Size)12023-01-09
B618E3ControlSeal Electrode Domes (Large Size)12023-01-09
B618E0Dome Electrodes12019-04-15
E40001ControlSeal Electrode Domes (Standard Size)12023-02-20
E50001ControlSeal Electrode Domes (Large Size)12023-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841747186912Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2025-05-28
00841747186929Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2025-05-28
00195411036455Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411036622Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411036790Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411036813Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411108602Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192298Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192304Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192311Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192328Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192342Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192359Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192366Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192373Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192380Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192397Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192403Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192410Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192427Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192434Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411214440Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411214457Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269150Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269167Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269174Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269181Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269198Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269204Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269211Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26