WowGoHealth Body Fat Analyzer GSH202-B

Basic Information

• Brand Name: WowGoHealth Body Fat Analyzer GSH202-B
• Primary DI: 04719878122023
• Version / Model: GSH202-B
• Company Name: GOLDEN SMART HOME TECHNOLOGY CORP.
• Labeler DUNS: 656002163
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-19
• Public Version: 1
• Public Version Date: 2020-04-27
• Public Version Status: New
• Public Device Record Key: c13630fb-c2a8-4cd0-946d-a64cc4fd594a

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PUH	Analyzer, Body Composition, Exempt	Cardiovascular	870.2770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36022	Bioelectrical body composition analyser	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14719878122020	GS1	Carton	5	In Commercial Distribution
Primary	04719878122023	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	321	Millimeter
Width	321	Millimeter
Height	22.5	Millimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 15 – 93 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 105 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 93 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal