EZY-TRAVEL WRISTBAND

• K Number: K041766
• Device Name: EZY-TRAVEL WRISTBAND
• Manufacturer: APOTHECARY PRODUCTS, INC.
• Date Cleared: 2004-11-26 ( 149 days)
• Product Code: MVV
• Regulation Number: N/A
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

For the relief of nausea. Nausea may be caused by motion, morning sickness, chemotherapy or anesthesia.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for the "Ezy-Travel Wristbands," an acupressure device. This letter indicates a finding of substantial equivalence to a legally marketed predicate device for the stated indications for use (relief of nausea).

However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for the device. The letter solely states that the device is substantially equivalent and can be marketed.

Therefore, I cannot provide the requested information from the given text. The document does not describe the acceptance criteria or a study that proves the device meets them.

Regulation Number and Section

N/A