Contact Heat-Evoked Potential Stimulator (CHEPS)
by Medoc Ltd. Advanced Medical Systems
510(k) K041908
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK041908 | Date25 Feb 2005 | 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- Withdrawn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
- NTU
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1870
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Contact Heat-Evoked Potential Stimulator (CHEPS) is a thermal evoked potential stimulator designed to assess human thermal and nociceptive pathways. It delivers controlled heat stimuli via a thermode sensor to evoke measurable neural responses, facilitating objective evaluation of pain perception in clinical and research settings. Classified under the device type 'Evoked Potential Stimulator, Thermal,' it is intended for use in neurology applications.
The CHEPS is used in conjunction with EEG recording systems and may integrate with functional MRI (fMRI) capabilities for comprehensive pain pathway analysis. Supplied as a reusable medical device, it adheres to FDA 510(k) clearance (K041908) under the Traditional review pathway, with a classification of Class II. The device employs a heated thermode sensor with a sharp stimulus slope, triggering EEG signals via BNC cable for precise data acquisition.
Other devices from Medoc Ltd. Advanced Medical Systems
Questions
AI-generated answers, 19 Sep 2026
What clinical applications is the CHEPS primarily used for in neurology settings?
The CHEPS is designed to assess human thermal and nociceptive pathways by delivering controlled heat stimuli via a thermode sensor. This allows clinicians to objectively evaluate pain perception and neural responses, which is particularly useful in neurology for studying conditions related to pain processing, such as neuropathies or central pain syndromes. It integrates with EEG systems and can also be used with fMRI for advanced pain pathway analysis.
Is the CHEPS a single-use or reusable device, and what does this mean for maintenance?
The CHEPS is supplied as a reusable medical device, meaning it is intended for repeated use across multiple patients or sessions. This design allows for cost-effective operation in clinical or research settings, though proper cleaning, sterilization, and maintenance protocols must be followed to ensure safety and performance between uses. The manufacturer’s instructions should be consulted for specific care guidelines.
How does the CHEPS connect to recording systems, and what type of data does it generate?
The CHEPS triggers EEG signals through a BNC cable, enabling direct integration with EEG recording systems. The device delivers controlled heat stimuli via a thermode sensor, evoking measurable neural responses that are captured as evoked potentials. These signals help clinicians analyze pain perception and neural pathway function in real-time, supporting diagnostic or research applications.
What regulatory pathway was followed for FDA clearance of the CHEPS, and what does this imply for its use?
The CHEPS received FDA clearance through the Traditional 510(k) review pathway, classified as substantially equivalent to a predicate device under the classification of Class II. This means the device underwent a thorough evaluation by the FDA’s Neurology (NE) advisory committee to ensure safety and effectiveness for its intended use in assessing thermal and nociceptive pathways. The clearance (K041908) confirms it meets regulatory standards for clinical or research applications in neurology.