Sense System

JSON twin: https://www.healthaidb.com/software/sense-system.json

Company Name

Infinite Biomedical Technologies

Product URL

https://www.infinitebiomedical.com/sense-system

Company URL

https://www.infinitebiomedical.com

Categories

• clinical Care
• assistive Technology
• prosthetics
• neurology
• Clinical
• Physical Medicine

Summary

The Sense System is a myoelectric prosthetic controller developed by Infinite Biomedical Technologies, enabling intuitive control of prosthetic hands through surface electromyography (EMG) and pattern recognition.

Description

The Sense System integrates surface electrodes for EMG with a pattern recognition controller, facilitating precise control of prosthetic hands. It is compatible with various prosthetic hands, including Espire Pro/Hybrid, Bebionic, Michelangelo Hand, and iLimb, offering users enhanced functionality and adaptability. The system has received FDA clearance under 510(k) number K182112, confirming its safety and effectiveness for medical use. Additionally, the Sense System is listed in the FDA's Global Unique Device Identification Database (GUDID) with device identifiers 00850004850268, 00850004850077, and 00850004850466, corresponding to different prosthetic hand models. The company, Infinite Biomedical Technologies, LLC, is based in Baltimore, Maryland, and specializes in developing advanced prosthetic technologies to improve the quality of life for individuals with upper limb differences.

Api Available

yes

Certifications

• ISO 17027
• NIST-traceable Calibration Certificate
• UN 38.3
• IEC 60086-4
• RoHS
• REACH
• FCC
• CE
• RED
• GCF/PTCRB

Company Founding

1997

Company Offices

• United States

Compliance

• ISO 17027
• NIST-traceable Calibration Certificate
• UN 38.3
• IEC 60086-4
• RoHS
• REACH
• FCC
• CE
• RED
• GCF/PTCRB

Customers

Data Residency

Global coverage in 40+ countries

Data Standards

• ISO 17027
• NIST-traceable Calibration Certificate
• UN 38.3
• IEC 60086-4
• RoHS
• REACH
• FCC
• CE
• RED
• GCF/PTCRB

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Real-time shipment monitoring
• Temperature, pressure, humidity, tilt, and shock sensors
• Non-intrusive parcel open/close detection
• Geolocation and geofencing alerts
• Condition monitoring for regulatory compliance
• Data and device management API
• Shipment data API
• Data enrichment with AI and third-party integrations
• Cellular connectivity with global coverage
• Customizable reporting and analytics
• Automated data retention policies
• Role-based access controls
• Secure data transmission with AES-256 encryption
• Integration with cloud-based supply chain management solutions
• Real-time exception detection and alerts
• Battery life up to 2 years
• Shelf life up to 3 years
• Ingress Protection Rating: IP64
• Temperature accuracy: ±0.5°C

Id

SW0579

Integration Partners

Integrations

• Active Directory
• LDAP
• TACACS
• TACACS+
• RADIUS
• Duo
• Google Authenticator
• Microsoft Authenticator
• Okta
• RSA
• SmartCards
• SMS
• Symantec VIP
• Tokens
• AWS
• Azure
• GCP
• Jenkins
• GitLab
• RPA platforms
• Chatbot platforms

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• consumer

Optional Modules

• Cold Chain variant compliant with GDP
• HSM Integration for enhanced security

Os Platforms

• Web
• iOS
• Android
• Windows
• macOS
• Linux

Pricing Details

Pricing details are not publicly disclosed; interested parties should contact Infinite Biomedical Technologies directly for information.

Pricing Model

contact vendor

Privacy Features

• GDPR compliance
• Data minimization
• Strict data retention policies with automatic deletion
• Automatic blurring of faces in video feeds
• License plate masking in stored images
• Data residency options
• Incident response plan with 24/7 monitoring
• Secure data transmission with AES-256 encryption
• Secure API endpoints with authentication and authorization checks

Product Code

SW0579

Product Name

Sense System

Ratings

Regions Available

• United States

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

Security Features

• AES-256 encryption
• Role-based access controls
• Secure data transmission
• HSM Integration for enhanced security
• Data retention policies
• Secure API endpoints with authentication and authorization checks
• Incident response plan with 24/7 monitoring
• Automatic blurring of faces in video feeds
• License plate masking in stored images
• Data minimization
• Strict data retention policies with automatic deletion

Specialties

• Neurology
• Physical Medicine

Support Channels

System Requirements

AWS, Azure, GCP, Jenkins, GitLab, RPA platforms, Chatbot platforms

Target Users

• patients
• clinicians
• prosthetists

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "Sense System",
  "company_name": "Infinite Biomedical Technologies",
  "product_url": "https://www.infinitebiomedical.com/sense-system",
  "company_url": "https://www.infinitebiomedical.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0579",
  "summary": "The Sense System is a myoelectric prosthetic controller developed by Infinite Biomedical Technologies, enabling intuitive control of prosthetic hands through surface electromyography (EMG) and pattern recognition.",
  "description": "The Sense System integrates surface electrodes for EMG with a pattern recognition controller, facilitating precise control of prosthetic hands. It is compatible with various prosthetic hands, including Espire Pro/Hybrid, Bebionic, Michelangelo Hand, and iLimb, offering users enhanced functionality and adaptability. The system has received FDA clearance under 510(k) number K182112, confirming its safety and effectiveness for medical use. Additionally, the Sense System is listed in the FDA's Global Unique Device Identification Database (GUDID) with device identifiers 00850004850268, 00850004850077, and 00850004850466, corresponding to different prosthetic hand models. The company, Infinite Biomedical Technologies, LLC, is based in Baltimore, Maryland, and specializes in developing advanced prosthetic technologies to improve the quality of life for individuals with upper limb differences.",
  "categories": [
    "clinical Care",
    "assistive Technology",
    "prosthetics",
    "neurology",
    "Clinical",
    "Assistive Technology",
    "Prosthetics",
    "Neurology",
    "Physical Medicine"
  ],
  "market_segment": [
    "enterprise",
    "consumer"
  ],
  "target_users": [
    "patients",
    "clinicians",
    "prosthetists"
  ],
  "specialties": [
    "Neurology",
    "Physical Medicine"
  ],
  "regions_available": [
    "United States"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "contact vendor",
  "pricing_details": "Pricing details are not publicly disclosed; interested parties should contact Infinite Biomedical Technologies directly for information.",
  "license": "commercial",
  "company_offices": [
    "United States"
  ],
  "company_founding": "1997",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Real-time shipment monitoring",
    "Temperature, pressure, humidity, tilt, and shock sensors",
    "Non-intrusive parcel open/close detection",
    "Geolocation and geofencing alerts",
    "Condition monitoring for regulatory compliance",
    "Data and device management API",
    "Shipment data API",
    "Data enrichment with AI and third-party integrations",
    "Cellular connectivity with global coverage",
    "Customizable reporting and analytics",
    "Automated data retention policies",
    "Role-based access controls",
    "Secure data transmission with AES-256 encryption",
    "Integration with cloud-based supply chain management solutions",
    "Real-time exception detection and alerts",
    "Battery life up to 2 years",
    "Shelf life up to 3 years",
    "Ingress Protection Rating: IP64",
    "Temperature accuracy: ±0.5°C"
  ],
  "optional_modules": [
    "Cold Chain variant compliant with GDP",
    "HSM Integration for enhanced security"
  ],
  "integrations": [
    "Active Directory",
    "LDAP",
    "TACACS",
    "TACACS+",
    "RADIUS",
    "Duo",
    "Google Authenticator",
    "Microsoft Authenticator",
    "Okta",
    "RSA",
    "SmartCards",
    "SMS",
    "Symantec VIP",
    "Tokens",
    "AWS",
    "Azure",
    "GCP",
    "Jenkins",
    "GitLab",
    "RPA platforms",
    "Chatbot platforms"
  ],
  "data_standards": [
    "ISO 17027",
    "NIST-traceable Calibration Certificate",
    "UN 38.3",
    "IEC 60086-4",
    "RoHS",
    "REACH",
    "FCC",
    "CE",
    "RED",
    "GCF/PTCRB"
  ],
  "api_available": "yes",
  "system_requirements": "AWS, Azure, GCP, Jenkins, GitLab, RPA platforms, Chatbot platforms",
  "compliance": [
    "ISO 17027",
    "NIST-traceable Calibration Certificate",
    "UN 38.3",
    "IEC 60086-4",
    "RoHS",
    "REACH",
    "FCC",
    "CE",
    "RED",
    "GCF/PTCRB"
  ],
  "certifications": [
    "ISO 17027",
    "NIST-traceable Calibration Certificate",
    "UN 38.3",
    "IEC 60086-4",
    "RoHS",
    "REACH",
    "FCC",
    "CE",
    "RED",
    "GCF/PTCRB"
  ],
  "security_features": [
    "AES-256 encryption",
    "Role-based access controls",
    "Secure data transmission",
    "HSM Integration for enhanced security",
    "Data retention policies",
    "Secure API endpoints with authentication and authorization checks",
    "Incident response plan with 24/7 monitoring",
    "Automatic blurring of faces in video feeds",
    "License plate masking in stored images",
    "Data minimization",
    "Strict data retention policies with automatic deletion"
  ],
  "privacy_features": [
    "GDPR compliance",
    "Data minimization",
    "Strict data retention policies with automatic deletion",
    "Automatic blurring of faces in video feeds",
    "License plate masking in stored images",
    "Data residency options",
    "Incident response plan with 24/7 monitoring",
    "Secure data transmission with AES-256 encryption",
    "Secure API endpoints with authentication and authorization checks"
  ],
  "data_residency": "Global coverage in 40+ countries",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0579",
  "slug": "sense-system",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/sense-system.json"
  }
}