Neuromatic 2000
by Disa Electronics 510(k)
Active
510(k) K821237
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK821237 | Date21 May 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- IKN
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.1375
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Neuromatic 2000 is an electromyograph, a diagnostic device used to measure and record electrical activity produced by skeletal muscles at rest and during contraction. It is designed for electromyography measurements and evoked response examinations, enabling clinicians to assess muscle and nerve function.
This device is supplied as a reusable medical instrument and is classified under FDA regulation 890.1375 as a Class II diagnostic device. It is intended for use in clinical settings, including physical medicine, and requires proper maintenance and calibration. The Neuromatic 2000 holds an FDA 510(k) clearance (K821237) under the Traditional pathway, with a decision date of May 21, 1982.
Other devices from Disa Electronics
Questions
AI-generated answers, 19 Sep 2026
What clinical specialties primarily use the Neuromatic 2000, and why is it relevant to them?
The Neuromatic 2000 is primarily used in physical medicine settings, as indicated by its advisory committee classification. Clinicians in this specialty rely on electromyography (EMG) to diagnose and monitor neuromuscular disorders, nerve injuries, and muscle dysfunction. The device’s ability to measure electrical activity in skeletal muscles at rest and during contraction helps assess nerve conduction and muscle response, which is critical for evaluating conditions like neuropathy, myopathy, or radiculopathy.
Is the Neuromatic 2000 intended for single-use or reusable applications, and what maintenance does it require?
The Neuromatic 2000 is designed as a reusable medical instrument, meaning it is meant for repeated use in clinical settings. Since it is reusable, it requires proper maintenance and calibration to ensure accurate and reliable performance. Regular servicing, cleaning, and adherence to manufacturer guidelines are essential to uphold its diagnostic integrity over time.
How is the Neuromatic 2000 regulated, and what does its FDA clearance status indicate?
The Neuromatic 2000 holds an FDA 510(k) clearance (K821237) under the Traditional pathway, granted on May 21, 1982. This classification indicates the device was determined to be substantially equivalent to a legally marketed predicate device at the time of review. While this clearance confirms its compliance with FDA standards for Class II diagnostic devices, it does not imply ongoing approval—rather, it establishes the device’s regulatory pathway for electromyography use in clinical settings.
What types of examinations or procedures can the Neuromatic 2000 perform, and how does it support diagnostic workflows?
The Neuromatic 2000 is specifically designed for electromyography (EMG) measurements and evoked response examinations. It enables clinicians to assess muscle and nerve function by recording electrical activity during rest and contraction, as well as in response to stimuli. This data helps diagnose conditions like nerve compression, muscular dystrophy, or peripheral neuropathy, making it a foundational tool in neuromuscular diagnostics.