FDA.reportPublic FDA data

WowGoHealth Body Fat Analyzer GSH202-B

Primary DI
14719878122020
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
Rx
false
OTC
true
Sterile
false
Single use
false

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
656002163
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
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
04719878122023WowGoHealth 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

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Primary DI, Brand, Company table
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