Catalog Number

-

Brand Name

Full Body Sensor Body Composition Monitor and Scale

Version/Model Number

HBF-510W

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

K062043,K062043

Product Code

MNW

Product Code Name

Analyzer, Body Composition

Public Device Record Key

52ac90e9-23b4-4490-8783-ea67c2c6b816

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

10073796265103

Quantity per Package

4

Contains DI Package

00073796265106

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case