Nomad TM-3400
510(k) K850109
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK850109 | Date4 Jun 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GWF
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1870
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Nomad TM-3400 is an electrical stimulator designed to evoke and record responses, classified as an Electrical, Evoked Response Stimulator. It is intended for use in neurological assessments, facilitating the measurement of physiological reactions to electrical stimulation in clinical settings. This device supports diagnostic procedures by enabling precise control over stimulus parameters, such as intensity and duration, to evaluate nerve or muscle function.
The Nomad TM-3400 is supplied as a reusable medical device and is regulated under FDA 510(k) clearance (K850109) with a classification as a Class II device (GWF). It is intended for use in neurology, adhering to MRI safety standards where applicable. The device requires proper calibration and maintenance as specified by the manufacturer. Storage conditions and handling should follow manufacturer guidelines to ensure functionality and patient safety.
Other devices from Tracor Northern, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Nomad TM-3400 used for in clinical settings?
The Nomad TM-3400 is designed as an Electrical, Evoked Response Stimulator to evoke and record physiological responses in neurological assessments. It helps clinicians measure how nerves or muscles react to electrical stimulation, aiding in the evaluation of nerve or muscle function during diagnostic procedures. This precise control over stimulus parameters like intensity and duration supports accurate diagnostic evaluations.
Is the Nomad TM-3400 a single-use or reusable device?
The Nomad TM-3400 is a reusable medical device. It is intended for repeated use in clinical settings, provided it is properly maintained and calibrated according to the manufacturer’s guidelines. Regular maintenance ensures its reliability and safety for ongoing neurological assessments.
What regulatory approval does the Nomad TM-3400 hold?
The Nomad TM-3400 is cleared by the FDA under the 510(k) pathway with the clearance number K850109. It is classified as a Class II device under the General Well-Fare (GWF) product code, indicating it has undergone review by the Neurology Advisory Committee for safety and effectiveness in its intended use.
How should the Nomad TM-3400 be stored and handled?
The Nomad TM-3400 must be stored and handled according to the manufacturer’s guidelines to ensure functionality and patient safety. Proper storage conditions help maintain its performance, especially since it is a reusable device. Follow the manufacturer’s instructions for calibration, cleaning, and maintenance to avoid compromising its accuracy or reliability in clinical use.
Can the Nomad TM-3400 be used in MRI-compatible environments?
The Nomad TM-3400 is designed with MRI safety standards in mind where applicable. However, specific compatibility details should be verified with the manufacturer’s documentation, as MRI environments require strict adherence to electromagnetic interference and safety protocols to protect both the device and patients.