NAICS Code 334510-01 - Electromedical/Therapeutic Apprts (Manufacturing)

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NAICS Code 334510-01 Description (8-Digit)

Electromedical/Therapeutic Apprts (Manufacturing) is a subdivision of the NAICS Code 334510 that involves the production of medical devices that use electricity or other forms of energy to diagnose, monitor, or treat various medical conditions. These devices are designed to be used in hospitals, clinics, and other healthcare facilities, as well as in the home. The industry is focused on developing and manufacturing innovative products that can improve patient outcomes and quality of life.

Hierarchy Navigation for NAICS Code 334510-01

Tools

Tools commonly used in the Electromedical/Therapeutic Apprts (Manufacturing) industry for day-to-day tasks and operations.

  • Electrodes
  • Ultrasound machines
  • Magnetic resonance imaging (MRI) machines
  • X-ray machines
  • CT scanners
  • ECG machines
  • Defibrillators
  • Pacemakers
  • Infusion pumps
  • Blood glucose monitors
  • Oxygen concentrators
  • Ventilators
  • Dialysis machines
  • Laser therapy devices
  • TENS units
  • EMG machines
  • EEG machines
  • Radiation therapy machines
  • Surgical lasers

Industry Examples of Electromedical/Therapeutic Apprts (Manufacturing)

Common products and services typical of NAICS Code 334510-01, illustrating the main business activities and contributions to the market.

  • Electrocardiogram machines
  • Electroencephalogram machines
  • Electroconvulsive therapy devices
  • Transcutaneous electrical nerve stimulation devices
  • Magnetic resonance imaging machines
  • Computed tomography scanners
  • Infusion pumps
  • Oxygen concentrators
  • Ventilators
  • Dialysis machines
  • Radiation therapy machines
  • Surgical lasers
  • Ultrasound machines
  • Blood glucose monitors
  • Laser therapy devices
  • TENS units
  • EMG machines
  • EEG machines
  • Defibrillators
  • Pacemakers

Certifications, Compliance and Licenses for NAICS Code 334510-01 - Electromedical/Therapeutic Apprts (Manufacturing)

The specific certifications, permits, licenses, and regulatory compliance requirements within the United States for this industry.

  • FDA Medical Device Establishment Registration: This registration is required for all facilities that manufacture, prepare, propagate, compound, or process medical devices intended for commercial distribution in the United States. The registration is issued by the U.S. Food and Drug Administration (FDA).
  • ISO 13485: This certification specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. The certification is issued by the International Organization for Standardization (ISO).
  • Good Manufacturing Practices (GMP): These are regulations enforced by the FDA to ensure that medical devices are consistently produced and controlled according to quality standards. The regulations cover all aspects of production, from the starting materials, premises, and equipment to the training and personal hygiene of staff.
  • Medical Device Reporting (MDR): This regulation requires manufacturers to report to the FDA any device-related death, serious injury, or malfunction that could lead to death or serious injury. The regulation also requires manufacturers to report certain device malfunctions that would not be likely to cause serious injury or death.
  • National Fire Protection Association (NFPA) 99: This standard provides criteria for healthcare facilities to minimize the hazards of fire, explosion, and electricity. The standard covers the installation, testing, and maintenance of electrical systems and equipment used in healthcare facilities.

History

A concise historical narrative of NAICS Code 334510-01 covering global milestones and recent developments within the United States.

  • The Electromedical/Therapeutic Apprts (Manufacturing) industry has a long history of technological advancements and innovations. The first recorded use of electricity for medical purposes dates back to the 18th century when Luigi Galvani discovered that electrical stimulation could cause muscle contractions in frogs. In the 19th century, the invention of the battery and the development of electrical generators led to the creation of electrotherapy devices. The first electrotherapy device was invented in 1855 by Guillaume Duchenne, who used it to treat neurological disorders. In the 20th century, the industry saw significant growth due to the development of new technologies such as X-rays, ultrasound, and magnetic resonance imaging (MRI). In recent years, the industry has seen a surge in demand for wearable medical devices, remote patient monitoring, and telemedicine. In the United States, the Electromedical/Therapeutic Apprts (Manufacturing) industry has a rich history of innovation and technological advancements. In the early 20th century, the industry saw significant growth due to the development of new technologies such as X-rays, electrocardiograms (ECGs), and pacemakers. In the 1960s, the first implantable pacemaker was invented by Wilson Greatbatch, which revolutionized the treatment of heart disease. In the 21st century, the industry has seen a surge in demand for medical devices that use artificial intelligence (AI) and machine learning (ML) to improve patient outcomes. For example, the FDA approved the first AI-powered diagnostic device in 2018, which uses ML algorithms to detect diabetic retinopathy. Overall, the Electromedical/Therapeutic Apprts (Manufacturing) industry has a long history of innovation and technological advancements, and it continues to play a critical role in improving patient outcomes and advancing medical science.

Future Outlook for Electromedical/Therapeutic Apprts (Manufacturing)

The anticipated future trajectory of the NAICS 334510-01 industry in the USA, offering insights into potential trends, innovations, and challenges expected to shape its landscape.

  • Growth Prediction: Growing

    The Electromedical/Therapeutic Apprts (Manufacturing) industry in the USA is expected to grow in the coming years due to the increasing demand for medical devices and equipment. The aging population and the rise in chronic diseases are driving the demand for medical devices, including electromedical and therapeutic apparatus. Additionally, technological advancements in the industry, such as the development of wireless and portable devices, are expected to further boost the growth of the industry. However, the industry may face challenges such as regulatory hurdles and pricing pressures. Overall, the industry is expected to experience steady growth in the coming years.

Industry Innovations for NAICS Code 334510-01

Recent groundbreaking advancements and milestones in the Electromedical/Therapeutic Apprts (Manufacturing) industry, reflecting notable innovations that have reshaped its landscape.

  • Wearable Medical Devices: The development of wearable medical devices has revolutionized the industry by providing patients with continuous monitoring and real-time data. These devices include smartwatches, fitness trackers, and other wearable devices that can monitor vital signs, track medication adherence, and provide alerts to healthcare providers.
  • Artificial Intelligence (AI) In Medical Devices: AI is being increasingly used in medical devices to improve diagnosis, treatment, and patient outcomes. AI-powered devices can analyze large amounts of data and provide personalized treatment plans for patients.
  • 3D Printing: The use of 3D printing technology in the manufacturing of medical devices has enabled the production of complex and customized devices. This technology has also reduced the time and cost of manufacturing medical devices.
  • Telemedicine: The COVID-19 pandemic has accelerated the adoption of telemedicine, which allows patients to receive medical care remotely. This technology has enabled patients to receive medical care from the comfort of their homes, reducing the need for in-person visits.
  • Nanotechnology: The use of nanotechnology in medical devices has enabled the development of smaller and more precise devices. Nanotechnology has also enabled the development of targeted drug delivery systems, which can deliver drugs directly to the affected area, reducing side effects.

NAICS Code 334510-01 - Electromedical/Therapeutic Apprts (Manufacturing)

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