FDA.reportPublic FDA data

WowGoHealth Body Fat Analyzer GSH202-B

Primary DI
04719878122023
Brand
WowGoHealth Body Fat Analyzer GSH202-B
Company
GOLDEN SMART HOME TECHNOLOGY CORP.
Model
GSH202-B
Device description
The Body Fat Analyzer measures weight and estimate BMI and calories, and uses bio-electrical impedance analysis (BIA) technology to estimate body fat ratio, water ratio, bone mineral mass, visceral fat level, protein and muscle mass in health adults. It is intended for use in the domestic setting only.Contraindications:1. The device is contraindicated for any female subject who may be suspected of, or is pregnant. Besides provided inaccurate readings, the affects of this device on the fetus are unknown. 2. The device is contraindicated for any person who is connected to a wearable or implantable electronic device or instrument such as a pacemaker or defibrillator.
Published
2020-04-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PUHAnalyzer, Body Composition, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUHAnalyzer, Body Composition, ExemptCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14719878122020PackageGS15In Commercial Distribution
04719878122023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471987812202014719878122020
04719878122023047198781220234719878122023

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height22.5Millimeter
Length321Millimeter
Width321Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal105 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+88635770693service@goldensmarthome.com.tw

Regulatory Flags#

DUNS number
656002163
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719878121125WowGoHealth Blood Glucose Test Strips - GSH-BGM902 - 2*25GSH-BGM902 - 2*252019-07-04
04719878123518WowGoHealth Infrared Ear & Forehead Thermometer GSH-351GSH-3512023-03-28
04719878124027WowGoHealth Pulse Oximeter GSH601GSH601Orange2021-01-26
04719878124010WowGoHealth Pulse Oximeter GSH601GSH601Gray2020-07-09
04719878122313WowGoHealth Bluetooth Body Fat AnalyzerGSH231 (A3K)2021-05-24
14719878122310WowGoHealth Bluetooth Body Fat AnalyzerGSH231 (A3K)2021-05-24
04719878120036WowGoHealth Automatic Arm Bluetooth Blood Pressure MonitorGSH8622020-08-07
34719878120037WowGoHealth Automatic Arm Bluetooth Blood Pressure MonitorGSH8622020-08-07
14719878122020WowGoHealth Body Fat Analyzer GSH202-BGSH202-B2020-04-19
04719878120029WowGoHealth Blood Pressure Monitor GSH885BGSH885B2019-05-17
34719878120020WowGoHealth Blood Pressure Monitor GSH885BGSH885B2019-05-17
04719878120012WowGoHealthBlood Pressure Monitor LS802-B2019-04-18
04719878123013WowGoHealth IR Ear Thermometer with Bluetooth GSH-BTS301GSH-BTS3012019-07-12
04719878121019WowGoHealth Blood Glucose Monitoring System GSH-BGM902GSH-BGM9022019-07-04
04719878121156WowGoHealth Control Solution - GSH-BGM902 - Level 1GSH-BGM902 - Level 12019-07-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04012030024921seca analytics 125seca GmbH & Co. KGPUH2026-06-02
06932825306118TeleRPMGuangdong Transtek Medical Electronics Co.,LtdPUH2026-05-29
06932825306125PulseGuangdong Transtek Medical Electronics Co.,LtdPUH2026-05-29
04719846013230CharderCHARDER ELECTRONIC CO., LTD.PUH2026-04-29
04719846016491CharderCHARDER ELECTRONIC CO., LTD.PUH2026-04-29
00810140063007RENPHOJoicom CorporationPUH2026-04-20
00810140062994RENPHOJoicom CorporationPUH2026-04-08
16977035520005ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520012ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520029ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520036ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520043ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520050ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520067ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520074ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520081ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520098ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520104ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520111ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520128ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520135ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520142ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520159ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520166ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520173ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520180ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520197ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
00694501143849Health O MeterStar Elite IncPUH2026-03-25
00694501143863Health O MeterStar Elite IncPUH2026-03-25
00810140062901RENPHOJoicom CorporationPUH2026-01-04