Catalog Number

COMFYEMS, COMFYEMS-JETT, COMFYEMS-TP, COMFYEMS-MFR

Brand Name

COMFYEMS

Version/Model Number

COMFYEMS

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K071951,K071951,K071951,K071951,K071951

Product Code

IPF

Product Code Name

Stimulator, Muscle, Powered

Public Device Record Key

13b53b82-e230-403d-a9f5-5e2b1440cc91

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

November 21, 2019

Package DI Number

10816924020256

Quantity per Package

32

Contains DI Package

00816924020389

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE-WITH 4040TC