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K Number
K983907
Device Name
RELIEFBAND NST DEVICE MODELS WB-2,WB-6,WB-R
Manufacturer
WOODSIDE BIOMEDICAL, INC.
Date Cleared
1999-12-09

(401 days)

Product Code
GZJ
Regulation Number
882.5890
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The ReliefBand® NST™ Device is indicated for use in the treatment of nausea and vomiting (NV) due to chemotherapy, motion sickness, and pregnancy. The ReliefBand® NST™ Device is indicated as an adjunct to antiemetics in reducing postoperative nausea (PON).

Device Description

ReliefBand® NST™ Device Models WB-2, WB-6, and WB-R

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the Relief Band® NST™ Device. This document does not contain information regarding acceptance criteria, device performance, or study details such as sample sizes, ground truth establishment, or expert qualifications. It only states that the device is "substantially equivalent" to legally marketed predicate devices and outlines its indications for use.

Therefore, I cannot provide the requested information based on the given text. A 510(k) summary or the full 510(k) submission would be needed to extract these details.

§ 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).