Data / Medical devices / France / Withings
Withings: FDA-registered device maker in Issy-les-Moulineaux Ile-de-France, France, 10 510(k) clearances
Withings is registered with the FDA (registration 3008820594) in Issy-les-Moulineaux Ile-de-France, France. It lists 13 device types. The FDA files 10 510(k) clearances under its listings, the newest dated November 10, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008820594
- Address
- 2 rue Maurice Hartmann, Issy-les-Moulineaux Ile-de-France, France, 92130
- Owner or operator
- Withings (France) (10035674)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer, Specification developer
- First device listed
- August 30, 2012
- Registered through
- 2026
- Brand names listed
- Scan Monitor (ScanWatch 2, HWA10), Scan Monitor (ScanWatch, HWA09), WBS04, WBS05, WBS06, WBS08, WBS09, WBS12 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Body Composition, Exempt | PUH | 2 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Clinical Electronic Thermometer | SDV | 2 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Exporter to the US | accessdata.fda.gov |
| Device, Galvanic Skin Response Measurement | GZO | 2 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Electrocardiograph | DPS | 2 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Electrocardiograph Software For Over-The-Counter Use | QDA | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Scale, Patient | FRW | 1 | Exporter to the US | accessdata.fda.gov |
| Scale, Stand-On, Patient | FRI | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Stethoscope, Electronic | DQD | 2 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Exporter to the US | accessdata.fda.gov |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Ventilatory Effort Recorder | MNR | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 10, 2025 | K252474 | Withings BeamO (SCT02) | DPS | Substantially Equivalent | Withings | accessdata.fda.gov |
| June 15, 2025 | K240795 | Withings ECG App | QDA | Substantially Equivalent | Withings | accessdata.fda.gov |
| September 6, 2024 | K231667 | Withings Sleep Rx | MNR | Substantially Equivalent | Withings | accessdata.fda.gov |
| April 29, 2024 | K240102 | Blood Pressure Monitor (TMB-2287-B) | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| August 23, 2023 | K230812 | Withings Scan Monitor 2.0 | DPS | Substantially Equivalent | Withings | accessdata.fda.gov |
| June 30, 2023 | K223374 | Blood Pressure Monitor | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| October 5, 2021 | K201456 | Scan Monitor | DPS | Substantially Equivalent | Withings SA | accessdata.fda.gov |
| March 9, 2021 | K202891 | Blood Pressure Monitor | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| June 17, 2016 | K160544 | Withings Thermo (Model SCT01) | FLL | Substantially Equivalent | Withings | accessdata.fda.gov |
| June 19, 2013 | K131395 | TRANSTEK BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 19, 2022 | 91523 | Class II | Ongoing | Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2) | A software bug eliminated the initial ECG activation and review of the ECG under a physician. However, the device is only cleared for use under the care of a physician. | accessdata.fda.gov |
Compare with other makers
- All makers of Ventilatory Effort Recorder
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Electrocardiograph Software For Over-The-Counter Use
- All makers of Analyzer, Body Composition, Exempt
- All makers of Oximeter
- All makers of Electrocardiograph
Updated November 10, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.