Catalog Number

-

Brand Name

Homedics

Version/Model Number

FMS-400J

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)

-

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

1cda290e-fdd2-4eb0-8cbb-b7c4f6902b58

Public Version Date

August 20, 2020

Public Version Number

2

DI Record Publish Date

June 01, 2020

Package DI Number

10031262089752

Quantity per Package

1

Contains DI Package

00031262089755

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-