Catalog Number

-

Brand Name

Mobius Therapy

Version/Model Number

KTR-201

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

May 31, 2023

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

K170205,K170205

Product Code

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Public Device Record Key

aeaf601d-d48e-40aa-9838-ed95fcd2056c

Public Version Date

October 23, 2019

Public Version Number

2

DI Record Publish Date

June 30, 2018

Package DI Number

00860074002238

Quantity per Package

40

Contains DI Package

00860074002207

Package Discontinue Date

May 31, 2023

Package Status

In Commercial Distribution

Package Type

Carton