RELIEFBAND MST DEVICE, MODELS RB-2, RB-6, RB-R

• K Number: K982967
• Device Name: RELIEFBAND MST DEVICE, MODELS RB-2, RB-6, RB-R
• Manufacturer: WOODSIDE BIOMEDICAL, INC.
• Date Cleared: 1999-02-23 ( 182 days)
• Product Code: GZJ
• Regulation Number: 882.5890
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

The ReliefBand® Device is indicated for the relief of nausea and vomiting (NV) due to motion sickness

Device Description

ReliefBand® Device Models RB-2, RB-6, and RB-R

AI/ML Overview

This document is a marketing clearance letter for the ReliefBand device, not a study describing acceptance criteria and device performance. Therefore, I cannot provide the requested information. The letter confirms that the device is substantially equivalent to legally marketed predicate devices for the indicated use of relieving nausea and vomiting due to motion sickness.

To answer your request, I would need a different type of document, such as a clinical study report or a summary of safety and effectiveness data.

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).