FDA.reportPublic FDA data

Withings®

Primary DI
03700546706400
Brand
Withings®
Company
WITHINGS
Model
HWA09
Published
2021-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph
DQAOximeter
DXHTransmitters And Receivers, Electrocardiograph, Telephone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2
DQAOximeterCardiovascular2
DXHTransmitters And Receivers, Electrocardiograph, TelephoneCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
13700546706407PackageGS110In Commercial Distribution
23700546706404PackageGS120In Commercial Distribution
03700546706400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1370054670640713700546706407
2370054670640423700546706404
03700546706400037005467064003700546706400

GMDN Terms#

Term, Definition table
TermDefinition
Wearable multiple physiological parameter recorder, reusableAn electrically-powered wearable device (e.g., wristband, watch, finger probe, head-worn sensor) designed to continuously or intermittently measure and record multiple physiological parameters [e.g., heart rate, respiration rate, electrocardiogram (ECG), haemoglobin oxygen saturation (Sp02), routine body movement] using one or more technologies [e.g., photoplethysmography (PPG), reflectance pulse oximetry, electrocardiography, accelerometry). The data is typically transferred to a smart device or central database for analysis, which might include evaluation of lifestyle factors (e.g., energy expenditure, activity level, sleep patterns). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius

Regulatory Flags#

DUNS number
260119720
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700546709937Withings®SCT02SCT02-032025-11-30
13700546709934Withings®SCT02SCT02-032025-11-30
03700546710209Withings®SCT02SCT02-022025-11-30
03700546708497Withings®WSM022024-10-03
13700546708494Withings®WSM022024-10-03
03700546708664Withings®WBS14-Black2024-02-14
13700546708661Withings®WBS14-Black2024-02-14
03700546708725Withings®WBS13-Olympics2023-10-05
13700546708722Withings®WBS13-Olympics2023-10-05
03700546708275Withings®HWA102023-09-07
13700546708272Withings®HWA102023-09-07
03700546708435Withings®WBS08-Black2023-08-30
03700546708442Withings®WBS08-White2023-08-30
13700546708432Withings®WBS08-Black2023-08-30
13700546708449Withings®WBS08-White2023-08-30
03700546708244Withings®WBS12C-White2023-08-28
03700546708237Withings®WBS12C-Black2023-06-08
13700546708234Withings®WBS12C-Black2023-06-08
03700546708190Withings®WBS13-Black2023-04-17
03700546708206Withings®WBS13-White2023-04-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06944413835153Telemetry MonitorEdan Instruments, Inc.DPS2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DPS2026-08-26
00634782101633Diagnostix™AMERICAN DIAGNOSTIC CORPDQA2026-08-25
06924054300647Medical GuardianSHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-21
06946725572221APKAPK Technology Co.,Ltd.DQA2026-08-21
00884838096738Cardiac WorkstationPhilips Medizin Systeme Böblingen GmbHDPS2026-08-18
00884838096745Cardiac WorkstationPhilips Medizin Systeme Böblingen GmbHDPS2026-08-18
06924054300913BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-18
06924054300920BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-18
06970404880000UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880017UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880024UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880031UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
00840118620987Endure IndustriesENDURE INDUSTRIESDQA2026-08-14
06946725572078APKAPK Technology Co.,Ltd.DQA2026-08-14
06946725572085APKAPK Technology Co.,Ltd.DQA2026-08-14
06946725572092APKAPK Technology Co.,Ltd.DQA2026-08-14
06924054300906BERRYSHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-07-30
06944413844919SE-1202 Series ElectrocardiographEdan Instruments, Inc.DPS2026-07-21
06944413847422SE-1202 Series ElectrocardiographEdan Instruments, Inc.DPS2026-07-21
00850048674028HeartBeam ECG SystemHeartBeam, Inc.DPS2026-07-16
00850048674028HeartBeam ECG SystemHeartBeam, Inc.DXH2026-07-16
04048675785910Masimo SpO2 Module for Vista 300/SShanghai Draeger Medical Instrument Co.,Ltd.DQA2026-07-13
00010939962218N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00093351041099N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013550N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013567N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113849N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11