FDA 510(k) · Movano
K241090: Evie Med Ring (Movano Inc. Dba Movano Health)
Movano Inc. Dba Movano Health received FDA 510(k) K241090 for Evie Med Ring, with a decision date of Nov 29, 2024 (substantially equivalent).
Prescription or OTC: Prescription (Rx) parsed from FDA documents (summary PDF: indications text (parsed))
FDA facts
| FDA number | K241090 |
|---|---|
| Pathway | 510(k) |
| Applicant | Movano Inc. Dba Movano Health |
| Device name | Evie Med Ring |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Apr 22, 2024 |
| Decision date | Nov 29, 2024 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
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.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DQA is "Oximeter", class 2, 21 CFR 870.2700.
Our labels for filtering: claim SpO2 / pulse oximetry, sensor Ring PPG. These are heuristics, not FDA fields.