Withings ECG App
Summary
Withings received 510(k) clearance for Withings ECG App, a QDA device. Cleared on 2025-06-15.
Details
Source
510(k) Clearance
External ID
K240795
Action Date
2025-06-15
Status
Traditional
Category
device
Product Code
QDA
Product Description
Withings ECG App. Product code: QDA.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Withings has received 3 total clearances in our database.
Withings has 4 FDA actions in our database, including 1 recall and 3 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Withings have FDA actions?
Withings has 4 FDA actions in our database, including 1 recall and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K240795" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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