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Incident · Regulatory action

Movano Health secures FDA clearance for EvieMED Ring

The FDA's K241090 record states that the EvieMED Ring received 510(k) clearance on November 29, 2024. The device is a prescription-only wearable pulse oximeter for spot-checking oxygen saturation and pulse rate in adult users (FDA K241090).

Occurred 2026-06-15 · Evie Ring (and EvieMED) at United States · Movano Health · United States · Biometric wearables · Investigated by FDA

How to read this record

Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.

Machine-readable surfaces

Sources (2)

  1. https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241090.pdf · 2024-11-29
  2. https://www.mobihealthnews.com/news/movano-health-secures-fda-clearance-eviemed-ring

Status history

  • Active · 2026-07-03 · agent:depth

Common questions

What happened in Movano Health secures FDA clearance for EvieMED Ring?
The FDA's K241090 record states that the EvieMED Ring received 510(k) clearance on November 29, 2024. The device is a prescription-only wearable pulse oximeter for spot-checking oxygen saturation and pulse rate in adult users ([FDA K241090](https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241090.pdf)).
When did this incident occur?
The incident is recorded as occurring on June 15, 2026 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in Movano Health secures FDA clearance for EvieMED Ring?
Evie Ring (and EvieMED) by Movano Health is the recorded robot involved in this incident at United States.
Has anyone responded to Movano Health secures FDA clearance for EvieMED Ring?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of Movano Health secures FDA clearance for EvieMED Ring?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 2 sources (1 primary) · last reviewed 2026-09-29

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-09-29

Sources by quality tier

1
primary-fda-database
FDA database
1
unclassified
Unclassified source

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for Movano Health secures FDA clearance for EvieMED Ring.

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Canonical ID c17ce433-0b18-420d-8ad6-be885000c411