Phazx VLD-100
510(k) K992129
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK992129 | Date17 Sep 1999 | 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- Withdrawn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
- GZO
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1540
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Phazx VLD-100 is a galvanic skin response measurement device, classified under the FDA’s product code GZO for neurology applications. It measures electrical conductance of the skin, providing data used in biofeedback assessments to evaluate autonomic nervous system activity. This Class 2 device is designed to support clinical or research evaluations of physiological responses related to stress, arousal, or emotional states.
The Phazx VLD-100 is supplied as a reusable medical device and is intended for use in clinical or research settings. It requires no sterilization but must be cleaned and maintained per manufacturer instructions to ensure accurate measurements. The device has been cleared by the FDA under the Traditional 510(k) pathway (K992129) and falls under regulation 21 CFR 882.1540. No specific MRI safety classification or single-use designation is stated in the regulatory data.
Questions
AI-generated answers, 1 Oct 2026
What is the Phazx VLD-100 used for?
The Phazx VLD-100 is designed to measure galvanic skin response, which assesses electrical conductance changes on the skin. These measurements help evaluate autonomic nervous system activity, particularly in clinical or research settings to analyze physiological responses related to stress, arousal, or emotional states. It supports biofeedback applications where understanding these responses is critical.
Is the Phazx VLD-100 single-use or reusable?
The Phazx VLD-100 is a reusable medical device. While it does not require sterilization, it must be cleaned and maintained according to the manufacturer’s instructions to ensure accurate and reliable measurements over repeated use. Proper maintenance is essential for preserving the device’s performance.
How is the Phazx VLD-100 regulated?
The Phazx VLD-100 has been cleared by the FDA under the Traditional 510(k) pathway (K992129) and falls under the product code GZO for neurology applications. It is classified as a Class 2 device and regulated under 21 CFR 882.1540. This clearance indicates it meets FDA standards for safety and effectiveness as a galvanic skin response measurement device.
Does the Phazx VLD-100 require sterilization?
No, the Phazx VLD-100 does not require sterilization. However, it must be cleaned and maintained per the manufacturer’s guidelines to prevent contamination and ensure consistent measurement accuracy. Regular cleaning helps sustain the device’s functionality for clinical or research use.
What settings is the Phazx VLD-100 intended for?
The Phazx VLD-100 is specifically intended for use in clinical and research environments. It is not designated for home use or non-professional settings. Its design supports applications where precise measurement of skin conductance is necessary, such as in biofeedback therapy or physiological studies.