Catalog Number

1151-94-50

Brand Name

MultiStim ECO

Version/Model Number

1151-94-50

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

March 15, 2025

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

K162086

Product Code

BXN

Product Code Name

STIMULATOR, NERVE, BATTERY-POWERED

Public Device Record Key

fa075423-604e-43c1-a4fb-96ebaa9efac9

Public Version Date

February 23, 2021

Public Version Number

2

DI Record Publish Date

November 11, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-