Duns Number:005175432
Device Description: GoWISE USA Digital Body Fat Scale - Measures Weight, Body Fat, Water & Bone Mass, 400 lbs GoWISE USA Digital Body Fat Scale - Measures Weight, Body Fat, Water & Bone Mass, 400 lbs Capacity, Tempered Glass (Lavender)
Catalog Number
-
Brand Name
GoWISE USA
Version/Model Number
GW22040
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FRI
Product Code Name
Scale, Stand-On, Patient
Public Device Record Key
524ecf48-39ea-4554-97ae-1161122e5e51
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
March 12, 2017
Package DI Number
20853821006362
Quantity per Package
4
Contains DI Package
10853821006365
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pallet
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |