COMPLETE CONTROL System Gen2

GUDID B618N1

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.

COAPT LLC

Myoelectric hand prosthesis

• Primary Device ID: B618N1
• NIH Device Record Key: 4cc491e6-b964-4207-ab1e-fdc8e88a0c92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMPLETE CONTROL System Gen2
• Version Model Number: 1
• Company DUNS: 078505297
• Company Name: COAPT LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B618N1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191083

FDA Product Code

• GXY: Electrode, Cutaneous

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: 2019-06-20
• Device Publish Date: 2019-06-12

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: 2019-11-26 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: 2019-06-20The 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.
• 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).