Sense System with IBT Electrodes

by Infinite Biomedical Technologies, LLC  · Based in United States →Smarter, Simpler. We build innovative, streamlined solutions for people with upper limb loss and difference.
Orthopedics Physical Medicine & Rehab Plastic Surgery

Contact for pricing
Regulatory Status Disclosed

Overview

The Sense System with IBT Electrodes is a surface electromyography (EMG) electrode system developed by Infinite Biomedical Technologies (IBT) to enhance the control of upper limb prosthetic devices. This system utilizes a sophisticated pattern recognition algorithm to interpret muscle signals, translating them into intuitive commands for prosthetic hands, wrists, and elbows. The IBT Electrodes, previously cleared by the FDA, detect the EMG signals, which are then processed by the Sense System’s control box.

Designed with user comfort and adaptability in mind, the Sense System features some of the smallest control box and electrodes available on the market, along with lower battery consumption for extended use. It includes user interface software that allows prosthetists and patients to view signals, calibrate, and adjust device settings. A unique feature is its single movement recalibration, saving time and effort for users. The system also integrates with a virtual training app, MyoTrain, and offers a mobile app for on-the-go calibration, making it more natural and adaptable to individual muscle contractions and changes in limb volume or fit. IBT’s mission is to improve the lives of individuals with limb loss through the development of meaningful devices, and the Sense System is a key part of their advanced technologies for upper-limb amputees.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Surface Electromyography (EMG) electrode system
  • AI-powered pattern recognition algorithm for prosthetic control
  • Enhances control of upper limb prosthetic devices
  • Detects EMG signals using IBT Electrodes
  • Compatible with various prosthetic hands, wrists, and elbows
  • Smallest control box and electrodes on the market
  • Lower battery consumption for extended use
  • User Interface Software for calibration and settings adjustment
  • Single movement recalibration feature
  • Virtual training app (MyoTrain) included
  • Mobile app for on-the-go calibration
  • Intuitive control based on phantom limb sensations
  • Adaptable to changes in fit, skin fatigue, or limb volume

Use Cases

  • Intuitive control of upper limb prostheses
  • Rehabilitation for individuals with upper limb loss
  • Pre-prosthetic training using virtual environments
  • Improving quality of life for amputees
  • Advancing prosthetic technology research and development

What Physicians Need to Know

Mobile Notification System
The Sense system includes a mobile phone application that allows users to recalibrate their system as needed and on the go. Users can add or remove movements, view signals, or update their calibration directly from the app.
Physician Tip

For clinicians working with the Sense System with IBT Electrodes for prosthetic control, focus on leveraging its pattern recognition capabilities to provide intuitive and adaptable control for upper limb prostheses. Utilize the system's software and mobile app for precise calibration and to accommodate changes in limb volume or muscle fatigue, ensuring optimal patient comfort and functionality. Encourage patients to use the mobile app for on-the-go adjustments to enhance their daily independence.

The Sense System with IBT Electrodes is designed to be compatible with an array of connected upper limb prosthetic devices, such as hands, wrists, or elbows. Its pattern recognition algorithm processes EMG signals to provide standardized output signals for these prostheses. The system also integrates with a mobile application for user-driven adjustments and recalibration. Virtual game-based training tools, like MyoTrain, can be used to help patients learn pattern recognition prior to receiving their prosthesis, providing a fun and realistic training environment.

Details

Category Neurology AI, Wearables & Remote Monitoring (RPM)
Pricing Contact for pricing
DeploymentDevice-based (integrated into prosthesis) with accompanying desktop software and mobile application.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Sense System with IBT Electrodes received FDA 510(k) clearance (K182112) on October 5, 2018. It is indicated for use exclusively for external prosthetic fittings of upper limbs, enhancing control of prosthetic devices through surface electromyography (EMG) and pattern recognition.

Integrations
EHR Not specified
Specialties Orthopedics, Physical Medicine & Rehab, Plastic Surgery

What the Web Says

The Sense System with IBT Electrodes is a surface electromyography (EMG) electrode system designed to enhance the control of upper limb prosthetic devices. It utilizes pattern recognition algorithms to interpret muscle signals and translate them into prosthetic movements, offering a more intuitive control for users. The system includes a control box and up to eight small, low-profile electrodes, aiming to minimize the fabrication footprint and reduce battery consumption. It is intended for prescription use and installed by prosthetists or trained clinicians.

Overall: Mixed

Strengths

  • Enhances control of upper limb prosthetics through intuitive pattern recognition.
  • Smallest control box and electrodes on the market, minimizing bulk.
  • Lower battery consumption for extended use.
  • Software allows for single movement recalibration, saving time and effort for patients.
  • Accommodates non-traditional myo patients with weaker signals due to multiple electrodes.
  • Includes a virtual training app (MyoTrain) for practice before receiving the prosthesis.

Limitations

  • Limited publicly available reviews from physicians, healthcare IT, or tech reviewers outside of promotional materials.
  • No specific reviews found on G2 or Capterra.
  • Reddit discussions primarily focus on the iBioMed academic program at McMaster University, not the product itself.
  • General Reddit discussions about electrodes or similar technologies sometimes mention issues like discomfort, difficulty in application, or limited effectiveness for pain relief (not directly related to prosthetic control).

Based on reviews from: AccessGUDID - NIH, accessdata.fda.gov, YouTube (Infinite Biomedical Technologies channel), Reddit (r/McMaster, r/ChronicPain, r/flexibility, r/CPTSDNextSteps, r/answers), FDA (510(k) Premarket Notification), McMaster's Faculty of Engineering, Quora, Root3 Labs, Tom's Guide, PMC (Medical Devices for Tremor Suppression: Current Status and Future Directions, Patient-Reported Satisfaction with Using a Rechargeable 10 kHz Spinal Cord Stimulation Device), Northwell Health, Cybernews, Trustpilot

Last updated: 2026-07-19

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Press & Coverage

FDA
Sense System with IBT Electrodes 510(k) Premarket Notification
This is a 510(k) Premarket Notification for the Sense System with IBT Electrodes by Infinite Biomedical Technologies, LLC, submitted to the FDA. The document lists the applicant and correspondent contacts, regulation number, and classification product code.
2026-04
AccessGUDID - NIH
DEVICE: Sense System with IBT Electrodes (00850004850183)
This NIH AccessGUDID entry provides details about the Sense System with IBT Electrodes, including its brand name, version, company name (Infinite Biomedical Technologies, LLC), and commercial distribution status. It describes the device as a single-patient, reappliable system for controlling prosthetic hands through amplified muscle action potentials.
unknown
Authorea
Innovative Approaches to Training in Evidence-Based Neurology - Authorea
This article discusses innovative approaches to training in evidence-based neurology and mentions the Sense System with IBT Electrodes as a device for prosthetic control using gesture-based learning algorithms that record EMG data. It highlights the system's safety and effectiveness for its intended use, with a classification model trained to recognize patterns.
2024-09
ResearchGate
Multimodal wrist-worn devices for seizure detection and advancing research: Focus on the Empatica wristbands | Request PDF
This research paper references the Sense System with IBT Electrodes in the context of prosthetic control using gesture-based learning algorithms that record EMG data to create a muscle movement imprint for each grip. It is mentioned within a discussion of AI/ML algorithms trained on labeled data.
2025-07
Innolitics
Wave Electrode (AE02-50) (K242326) u2014 FDA 510(k)
This FDA 510(k) document for the Wave Electrode lists the Sense System with IBT Electrodes as a related device, cleared by Infinite Biomedical Technologies, LLC on October 5, 2018. It provides context for similar cutaneous electrodes used in neurological applications.
2018-10
inknowvation.com
Infinite Biomedical Technologies Releases Innovative New Technology for Prosthetic Limb Control
This news article from 2013 announces the release of Infinite Biomedical Technologies' MORPHu2122 technology for upper limb myo-electric prosthetics, which is compatible with most commercially available prosthetic hands and wrists. It highlights the FDA approval of MORPHu2122 and its ability to provide near-perfect reliability in switching hand and wrist functions.
2013-08
YouTube
IBT's Innovations in Upper Limb Myoelectric Prostheses - YouTube
This YouTube video features Damini Agarwal, Director of Product Development at IBT, discussing the company's innovations in upper limb myoelectric prostheses, including the Sense System. She explains how the Sense System uses pattern recognition and up to eight electrodes to convert muscle signals into hand, wrist, and elbow movements without needing switching technologies.
2021-07
accessdata.fda.gov
Total Product Life Cycle (TPLC)
The FDA's Total Product Life Cycle (TPLC) database lists the Sense System with IBT Electrodes (K182112) as a cleared device. This entry provides a regulatory overview of the product within the FDA's system.
2026-07

Videos

Product demos, reviews, and walkthroughs for Sense System with IBT Electrodes.

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Frequently Asked Questions

The AI in the Sense System analyzes complex bioelectrical signals from IBT electrodes to identify patterns indicative of specific conditions, providing physicians with data-driven insights. It functions as a decision support tool, offering recommendations or risk assessments, but always requires physician oversight and final clinical judgment. The system processes EMG signals using a pattern recognition algorithm to translate them into output signals compatible with prosthetic devices.
The Sense System with IBT Electrodes has received FDA 510(k) clearance for its intended use in enhancing control of upper limb prosthetic devices. While specific details on data privacy and HIPAA compliance for this particular system are not extensively detailed in the provided snippets, FDA-approved AI medical devices are expected to adhere to rigorous safety and efficacy standards, which typically include data security and privacy protocols.
The Sense System with IBT Electrodes is designed to enhance control of upper limb prosthetic devices by detecting and processing EMG signals, offering a more intuitive control compared to traditional two-signal systems. Its digital signal processing and advanced noise rejection aim to improve signal quality. While direct comparative diagnostic accuracy against non-AI methods for specific conditions isn't detailed, the system's pattern recognition algorithm aims to overcome limitations of simpler control algorithms in prosthetics.
The provided information does not detail the specific cost structure or projected return on investment for the Sense System with IBT Electrodes. However, similar advanced EEG systems can range from a few hundred to tens of thousands of dollars, with costs influenced by factors like the number of channels, data quality, and software sophistication. Cost-effectiveness in a clinical setting would typically be evaluated based on improved patient outcomes, enhanced efficiency, and potential reduction in other treatment costs.
Like many AI-driven products, the performance of neural decoding algorithms relies on vast amounts of diverse, high-quality data, implying that limitations could arise from insufficient or biased training data. While the Sense System aims for advanced noise rejection, conventional EMG-based systems can be susceptible to electrical artifacts during stimulation, which can affect real-time control. The system is specifically intended for upper limb exoprosthetic fittings.
The provided information does not explicitly detail the Sense System's integration capabilities with EHR systems. However, medical device integration with EHR/EMR systems is crucial for automating data capture, enhancing patient monitoring, and driving real-time clinical insights. Such integrations typically involve standard protocols like HL7 or FHIR and require IT support for network connectivity and data transfer.
The Sense System with IBT Electrodes has undergone performance tests to demonstrate its safety and effectiveness compared to predicate devices. It was found substantially equivalent to the Coapt COMPLETE CONTROL System and uses IBT Electrodes previously cleared by the FDA. The efficacy and safety of AI algorithms in medical devices are generally supported by clinical trials and adherence to regulatory standards.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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