WowGoHealth Body Fat Analyzer GSH202-B

GUDID 14719878122020

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.

GOLDEN SMART HOME TECHNOLOGY CORP.

Bioelectrical body composition analyser

• Primary Device ID: 14719878122020
• NIH Device Record Key: c13630fb-c2a8-4cd0-946d-a64cc4fd594a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WowGoHealth Body Fat Analyzer GSH202-B
• Version Model Number: GSH202-B
• Company DUNS: 656002163
• Company Name: GOLDEN SMART HOME TECHNOLOGY CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +88635770693
• Email: service@goldensmarthome.com.tw

Device Dimensions

• Height: 22.5 Millimeter

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719878122023 [Primary]
GS1	14719878122020 [Package]; Contains: 04719878122023; Package: Carton [5 Units]; In Commercial Distribution

FDA Product Code

• PUH: Analyzer, Body Composition, Exempt

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-27
• Device Publish Date: 2020-04-19

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