Catalog Number

EMS 250

Brand Name

Therapist’s Choice® EMS 250

Version/Model Number

EMS 250

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"

Yes

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

-

Product Code

IPF

Product Code Name

Stimulator, Muscle, Powered

Public Device Record Key

8e4419ce-ca1c-4946-9122-256cfa9b96a1

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

August 02, 2019

Package DI Number

00815290016576

Quantity per Package

8

Contains DI Package

00815290016569

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case