Catalog Number

-

Brand Name

HOMEDICS

Version/Model Number

FB-380HJ-1PK

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

ISA

Product Code Name

Massager, Therapeutic, Electric

Public Device Record Key

7948016b-be8e-4d38-b47f-4cf5db8fe6fb

Public Version Date

August 20, 2020

Public Version Number

2

DI Record Publish Date

June 30, 2020

Package DI Number

10031262082265

Quantity per Package

1

Contains DI Package

00031262082268

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case