Catalog Number

-

Brand Name

Easy@Home foot massage mat EFM-05R

Version/Model Number

EFM-05R

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

K153520,K153520

Product Code

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Public Device Record Key

4f1b2aeb-d7e1-4fab-89c6-9a422500d5df

Public Version Date

November 08, 2021

Public Version Number

1

DI Record Publish Date

October 31, 2021

Package DI Number

10810038632039

Quantity per Package

30

Contains DI Package

00810038632032

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-