HIVOX DREAMATE DM-800

• K Number: K021952
• Device Name: HIVOX DREAMATE DM-800
• Manufacturer: HIVOX BIOTEK, INC.
• Date Cleared: 2003-05-02 ( 323 days)
• Product Code: GZJ
• Regulation Number: 882.5890
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

used to apply a minor electrical current to electrodes on patient's wrist skin to function as:

• Helping relieve nausea and vomiting due to motion sickness.

Device Description

Not Found

AI/ML Overview

I apologize, but the provided text is a 510(k) clearance letter from the FDA for a Transcutaneous Electrical Nerve Stimulator (TENS) device called "HIVOX DM-800."

This document does not contain information about:

1. Specific acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy).
2. Details of any study that proves the device meets acceptance criteria.
3. Sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance studies, or training set information.

The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use (helping relieve nausea and vomiting due to motion sickness) and outlines regulatory compliance requirements. It is a regulatory clearance, not a scientific publication detailing performance studies.

Therefore, I cannot provide the requested table and study details based on the input text.

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).