Withings
Boston, MA, US
Withings appears in FDA device records in Boston, MA. FDA records list 8 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Withings between 2011 and 2025. The busiest year on record is 2025, with 2. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252474 | Withings BeamO (SCT02) | DPS | Substantially Equivalent | |
| K240795 | Withings ECG App | QDA | Substantially Equivalent | |
| K231667 | Withings Sleep Rx | MNR | Substantially Equivalent | |
| K230812 | Withings Scan Monitor 2.0 | DPS | Substantially Equivalent | |
| K201456 | Scan Monitor | DPS | Substantially Equivalent | |
| K160544 | Withings Thermo (Model SCT01) | FLL | Substantially Equivalent | |
| K133125 | WITHINGS BLOOD PRESURE MONITOR | DXN | Substantially Equivalent | |
| K110872 | WITHINGS BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008820594 | 3008820594 | Withings | 2 rue Maurice Hartmann, Issy-les-Moulineaux Ile-de-France 92130 FR | 2026 | and 3 more, listed in full below |
| 3007836454 | 3007836454 | Withings Inc. | 225 Franklin street, Boston, MA 02110 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- PUHAnalyzer, Body Composition, Exempt
- SDVClinical Electronic Thermometer
- FLLContinuous Measurement Thermometer
- GZODevice, Galvanic Skin Response Measurement
- DPSElectrocardiograph
- QDAElectrocardiograph Software For Over-The-Counter Use
- DQAOximeter
- FRWScale, Patient
- FRIScale, Stand-On, Patient
- DQDStethoscope, Electronic
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- DXHTransmitters And Receivers, Electrocardiograph, Telephone
- MNRVentilatory Effort Recorder
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1280-2023 | 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. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain