# K241090: Evie Med Ring

- Pathway: 510(k) (Traditional)
- Applicant: Movano Inc. Dba Movano Health
- Decided: Nov 29, 2024 after 221 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K001085 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181006: BB-613 Watch Oximeter, Bio-Beat Technologies, Ltd. (2018) Summary page 5.

## Indications for 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 hemogilobin (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.

Source page: https://510kreport.com/device/K241090
Methodology: https://510kreport.com/methodology