Duns Number:656002163
Device Description: The Body Fat Analyzer measures weight and estimate BMI and calories, and uses bio-electric 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.
Catalog Number
-
Brand Name
WowGoHealth Body Fat Analyzer GSH202-B
Version/Model Number
GSH202-B
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PUH
Product Code Name
Analyzer, Body Composition, Exempt
Public Device Record Key
c13630fb-c2a8-4cd0-946d-a64cc4fd594a
Public Version Date
April 27, 2020
Public Version Number
1
DI Record Publish Date
April 19, 2020
Package DI Number
14719878122020
Quantity per Package
5
Contains DI Package
04719878122023
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |