NAICS UNIVERSITY · Free research for insurance agents
Electromedical and Electrotherapeutic Apparatus Manufacturing
NAICS 334510 · United States · 2022 edition
This U.S. industry comprises establishments primarily engaged in manufacturing electromedical and electrotherapeutic apparatus, such as magnetic resonance imaging equipment, medical ultrasound equipment, pacemakers, hearing aids, electrocardiographs, and electromedical endoscopic equipment.
Start with the work promised to the client.
For Electromedical and Electrotherapeutic Apparatus Manufacturing, clarify the services, contracts and consequences of an error. Review products liability, product recall, workers' compensation. Confirm which professional activities and additional services the proposed coverage actually addresses.
Questions to ask
- What types of devices are manufactured — diagnostic only, therapeutic, or implantable life-sustaining devices?
- Are any devices subject to FDA PMA approval rather than 510(k) clearance?
- What is the geographic distribution footprint — domestic only, or international markets including EU, Asia?
- Has the company experienced any product recalls, FDA warning letters, or significant products liability claims in the past five years?
- Does the company conduct or sponsor clinical trials involving its devices?
- For Electromedical and Electrotherapeutic Apparatus Manufacturing, what should the underwriter know about implantable or life-sustaining devices (pacemakers, defibrillators, neurostimulators) with direct patient safety consequences?
- For Electromedical and Electrotherapeutic Apparatus Manufacturing, what should the underwriter know about prior fda warning letters, consent decrees, or device recalls in the last several years?
- For Electromedical and Electrotherapeutic Apparatus Manufacturing, what should the underwriter know about products liability losses exceeding typical severity benchmarks for the class?
Activities described by this code
Other activities to examine
- Manufacturing medical irradiation apparatus: 334517 — Irradiation Apparatus Manufacturing;
- Manufacturing nonelectrical medical and therapeutic apparatus: 33911 — Medical Equipment and Supplies Manufacturing
Census classification reference
For educational purposes only. AI-generated insurance research and automated logic can contain errors. Independently verify classification and coverage decisions.
Compare another operationInsurance operations research — draft
Establishments in this class design, assemble, and manufacture electronic medical and therapeutic devices — ranging from diagnostic imaging systems (MRI, ultrasound, ECG) to implantable devices (pacemakers, hearing aids) and electrotherapeutic equipment. Operations typically involve precision electronic assembly, quality control testing, regulatory compliance activities, and distribution to hospitals, clinics, and medical distributors.
Questions to investigate
- What types of devices are manufactured — diagnostic only, therapeutic, or implantable life-sustaining devices?
- Are any devices subject to FDA PMA approval rather than 510(k) clearance?
- What is the geographic distribution footprint — domestic only, or international markets including EU, Asia?
- Has the company experienced any product recalls, FDA warning letters, or significant products liability claims in the past five years?
This insurance research was generated in April 2026. It has not received a complete human review. The October 12, 2026 audit checked codes and titles only, not descriptions or coverage assertions.