Search Results
Found 1 results
510(k) Data Aggregation
K Number
K241090Device Name
Evie Med Ring
Manufacturer
Movano Inc. dba Movano Health
Date Cleared
2024-11-29
(221 days)
Product Code
DQA, DOA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
Movano Inc. dba Movano Health
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EvieMED Ring is a wireless, non-invasive, and stand-alone pulse oximeter intended to be used for spot checking oxygen saturation of peripheral arterial hemoglobin (SpO2) and pulse rate of adult users with a condition that might benefit from monitoring. Only the Pulse Oximeter function of the EvieMED device provides medical data. The device is designed for use in a healthcare or home environment, during no motion conditions. It is not intended for critical care and out-of-hospital transport use and does not have alarms. It is available with a prescription and can aid in the diagnosis and treatment of health conditions.
Device Description
The EvieWED Ring is a rechargeable noninyasive wearable is an open arrow design that allows for a snug fit and comfort during fluctuations in fluid retention and/or weight changes. There is an optical sensor that collects physiological signals and an app that processes the signals and provides spot SpO2 and pulse rate (PR) measurements during a spot check on a user's connected iOS phone. The ring is designed to be worn continuously and is waterproof, allowing the user to wear the device during handwashing, showering, and bathing without damaging the ring.
The EvieMED Ring is designed for accurate pulse oximeter readings inside of a clinical setting. The device is for a single user but can be used for many users, with the rechargeable battery in the ring and the charger expected to last 2 years or more. The device is not life-sustaining or life-supporting and does not include alarms. It is not indicated for use in motion or in conditions of low perfusion.
The device is supplied in a labeled box that includes a wearable, a charger, a USB-C cable, and a quick start guide. The ring is provided in common ring sizes (e.g., US 5 through US 12). Operation of the device depends on connection to the user's device running iOS 16.0 and above where the EvieWED Ring Mobile Application has been installed and registered, and a user-supplied AC adaptor is required for recharging the charger.
Ask a Question
Page 1 of 1