WowGoHealth Bluetooth Body Fat Analyzer

Basic Information

• Brand Name: WowGoHealth Bluetooth Body Fat Analyzer
• Primary DI: 04719878122313
• Version / Model: GSH231 (A3K)
• 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: 2021-05-24
• Public Version: 1
• Public Version Date: 2021-06-01
• Public Version Status: New
• Public Device Record Key: a2207ccc-d09e-46b3-b530-1f8d38aaec52

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 healthy adults. This product is for indoor use only.

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: No
• 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	14719878122310	GS1	Carton	4	In Commercial Distribution
Primary	04719878122313	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	304	Millimeter
Width	304	Millimeter
Height	25	Millimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity