Alpha Control Liner System (ACLS)
Overview
The Alpha Control Liner System (ACLS) by Coapt is an innovative prosthetic interface designed to work seamlessly with the Coapt Gen2 Complete Control System. It features embedded electrodes and leads within a gel-covered locking liner, simplifying the complex process of electrode placement. Developed in collaboration with Shirley Ryan AbilityLab, the ACLS improves myoelectric signal consistency by minimizing electrode lift-off, which is crucial for accurate pattern recognition. This leads to enhanced intuitive control, allowing users to achieve a greater range of motion and more natural prosthetic movements. The system also prioritizes patient comfort, offering improved socket comfort and easier donning and doffing of the prosthesis. It is available for both transradial and transhumeral upper limb prosthesis wearers.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Embedded electrodes and leads in a gel-covered locking liner
- Simplifies electrode placement and fabrication process
- Improves signal consistency by minimizing electrode lift-off
- Enhances user control and allows greater range of motion (e.g., 11% greater elbow ROM)
- Improved socket comfort and easier donning & doffing for patients
- Compatible with Coapt Gen2 Complete Control System
- Available for transradial and transhumeral users
- Integrated electrode design ensures consistent contact and improved signal fidelity
Use Cases
- Improving intuitive control of upper limb prostheses
- Enhancing comfort and ease of use for prosthesis wearers
- Simplifying the fitting and evaluation process for prosthetists and clinicians
- Providing a consistent and reliable interface for myoelectric pattern recognition systems
- Facilitating natural movement intent decoding for bionic upper limbs
What Physicians Need to Know
For upper limb prosthetists, the Alpha Control Liner System (ACLS) simplifies the fitting process by eliminating complex electrode placement and improving signal consistency through embedded electrodes. This leads to more reliable myoelectric signal capture for pattern recognition, enhancing intuitive control and comfort for patients using myoelectric prostheses. Practitioners can expect an easier fitting and evaluation process with less time spent on adjustments, while patients may experience increased device comfort, a wider range of motion, and an expanded functional envelope. It is designed for external prosthetic fittings of upper limbs.
The Alpha Control Liner System is designed to integrate exclusively with the Coapt Gen2 Complete Control System, which utilizes machine learning and AI for pattern recognition to decode muscle signals for intuitive prosthetic control. It serves as an alternative to traditional socket-embedded electrode systems. The system is compatible with most upper limb powered prosthetic components supported by Coapt Complete Control Pattern Recognition (Gen2).
Details
| Category | Neurology AI, Wearables & Remote Monitoring (RPM) |
| Pricing | Contact for pricing |
| Deployment | Integrated as an add-on component within the prosthetic arm |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated The Alpha Control Liner System (ACLS) received FDA 510(k) clearance (K223738) on January 11, 2023, as a Class II cutaneous electrode device (Product Code GXY, Regulation Number 21 CFR 882.1320). It is intended for use in conjunction with the Coapt Complete Control System Gen2 for external prosthetic fittings of the upper limbs. |
| Integrations | |
| EHR | Not specified |
| Specialties | Orthopedics, Physical Medicine & Rehab, Plastic Surgery |
What the Web Says
The Alpha Control Liner System (ACLS) is a next-generation prosthetic interface developed by Coapt and WillowWood, designed for upper limb myoelectric prostheses. It aims to improve user control and comfort by embedding electrodes and leads directly into a gel-covered locking liner, simplifying electrode placement and ensuring consistent signal capture. The system is intended to work exclusively with the Coapt Gen2 Complete Control System, which uses machine learning for intuitive prosthetic control.
Overall: MixedStrengths
- Improves user control and allows for greater elbow range of motion.
- Eliminates the complex process of electrode placement, simplifying the fitting and fabrication process for prosthetists.
- Enhances signal consistency by minimizing electrode lift-off, leading to better functional control.
- Offers improved socket comfort and easier donning and doffing for patients.
- Accommodates fluctuating edema throughout the day without interrupting suction.
- Biocompatibility tested for healthy skin contact.
Limitations
- Increased power consumption compared to its predicate device, the Complete Control System Gen2.
- Some users of WillowWood Alpha liners (not specifically ACLS) have reported issues with liners losing shape or degrading internally within a few months.
- Only custom on the inside, which may not properly conform to significantly unique limb shapes, potentially leading to discomfort or the need for alternative liners.
- Requires annual physician visits for continued use and prescription affirmation due to medical necessity and coding requirements.
- The electrodes are made with stainless steel containing nickel, which may be an issue for patients with nickel sensitivity or allergy.
- Exclusively designed to work with the Coapt Complete Control System Gen2; use with other products may void the warranty and negatively affect performance.
Based on reviews from: accessdata.fda.gov, Reddit, YouTube, Ortho Europe, The O&P EDGE Magazine, PR Newswire, WillowWood, Hanger, Massons Healthcare
Last updated: 2026-07-17
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