FDA.reportPublic FDA data

Withings®

Primary DI
13700546708661
Brand
Withings®
Company
WITHINGS
Model
WBS14-Black
Published
2024-02-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
GZODevice, Galvanic Skin Response Measurement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZODevice, Galvanic Skin Response MeasurementNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
13700546708661PackageGS14In Commercial Distribution
03700546708664PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1370054670866113700546708661
03700546708664037005467086643700546708664

GMDN Terms#

Term, Definition table
TermDefinition
Bioelectrical body composition analyserAn electronic device designed to estimate body composition (i.e., percent body fat, lean, bone, and/or hydration) with regards to bioelectrical impedance analysis (BIA) and often personal characteristics (e.g., age, gender, height, weight). It may be in the form of a unit with electrodes applied to the surface of the patient’s body, or a scale(s) placed on the floor and upon which the patient stands to measure total body weight. Both types perform BIA by passing a low electrical current through the body; personal characteristics may be manually entered. Data are analysed to provide measurements that may include body mass index (BMI), fat/muscle/bone mass, and total body water percent.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
260119720
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
13700546708197Withings®WBS13-Black2023-04-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05999860882046QUEX EDQX WORLD LTDGZO2026-04-27
05999860882053QUEX SQX WORLD LTDGZO2026-04-27
05999860882060QUEX EDQX WORLD LTDGZO2026-04-27
05999860882077QUEX SQX WORLD LTDGZO2026-04-27
00853858006546Empatica Health Monitoring PlatformEMPATICA SRLGZO2026-02-16
00853858006751Empatica Health Monitoring PlatformEMPATICA SRLGZO2026-02-16
00853858006584EmpaticaEMPATICA SRLGZO2025-06-26
00850068747092Happy HealthHAPPY HEALTH, INC.GZO2025-04-02
00850068747108Happy HealthHAPPY HEALTH, INC.GZO2025-04-02
00850068747115Happy HealthHAPPY HEALTH, INC.GZO2025-04-02
00850068747122Happy HealthHAPPY HEALTH, INC.GZO2025-04-02
00850068747139Happy HealthHAPPY HEALTH, INC.GZO2025-04-02
00850068747146Happy HealthHAPPY HEALTH, INC.GZO2025-04-02
00850068747153Happy HealthHAPPY HEALTH, INC.GZO2025-04-02
00850068747160Happy HealthHAPPY HEALTH, INC.GZO2025-04-02
00850068747177Happy HealthHAPPY HEALTH, INC.GZO2025-04-02
08690020003024SudoCheckMedeia, Inc.GZO2025-02-05
00840067103555Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-11-15
00840067103562Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-11-15
00840067103623Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-11-15
00840067103630Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-11-15
00840067103999CadwellCADWELL INDUSTRIES, INC.GZO2024-08-23
00840067102992Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-08-23
00840067103517Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-06-21
00840067103524Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-06-21
B322G0011ANS1 SoftwareLD TECHNOLOGY, LLCGZO2024-03-05
00840067102879Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-03-04
00840067102886Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-03-04
00840067102893Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-03-04
00840067102909Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-03-04