Coapt Evaluation Kit

GUDID B618Q1

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.

COAPT LLC

Bioelectrical signal analysis software

• Primary Device ID: B618Q1
• NIH Device Record Key: 34785ef6-f6ed-47e0-9a13-754e1540398c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coapt Evaluation Kit
• Version Model Number: 1
• Company DUNS: 078505297
• Company Name: COAPT LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B618Q1 [Primary]

FDA Product Code

• IQO: Device, Prosthesis Alignment

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-26
• Device Publish Date: 2019-11-18

Devices Manufactured by COAPT LLC

• E10001 - ControlSeal Electrode Domes (Standard Size): 2023-12-18 Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG).
• B618E3 - ControlSeal Electrode Domes (Large Size): 2023-12-18 Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG).
• E40001 - ControlSeal Electrode Domes (Standard Size): 2023-02-28 Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG).
• E50001 - ControlSeal Electrode Domes (Large Size): 2023-02-28 Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG).
• B618Q1 - Coapt Evaluation Kit: 2019-11-26The 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.
• B618Q1 - Coapt Evaluation Kit: 2019-11-26 The Coapt Evaluation Kit is a handheld clinical tool created with technology from the Coapt COMPLETE CONTROL System Gen2. It is
• B618P1 - Gen2 System Kit: 2019-06-27 The Gen2 System Kit is a medical device kit that contains the Coapt COMPLETE CONTROL System Gen2 (DI=B618N1) and the Coapt Dome
• B618N1 - COMPLETE CONTROL System Gen2: 2019-06-20 The COMPLETE CONTROL System Gen2 is an advanced control solution designed to provide the functionality of a powered myoelectric
• B618E0 - Dome Electrodes: 2019-04-23 Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG).