PHAZX VLD-100

• K Number: K992129
• Device Name: PHAZX VLD-100
• Manufacturer: PHAZX SYSTEMS, INC.
• Date Cleared: 1999-09-17 ( 86 days)
• Product Code: GZO
• Regulation Number: 882.1540
• Type: Traditional
• Panel: Neurology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

measurement of galvanic skin resistance, for biofeedback information

Device Description

Not Found

AI/ML Overview

The provided documents are a 510(k) clearance letter from the FDA for the VLD-100 device and an "Indications for Use" form. These documents do not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other details about the device's validation study. The letter simply states the device is "substantially equivalent" to predicate devices, which is the basis for 510(k) clearance, but it does not include the performance data that led to this determination.

Regulation Number and Section

§ 882.1540 Galvanic skin response measurement device.

(a)
Identification. A galvanic skin response measurement device is a device used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.