Catalog Number

KINFP

Brand Name

INF PLUS

Version/Model Number

INF PLUS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 01, 2019

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

K921441

Product Code

LIH

Product Code Name

Interferential Current Therapy

Public Device Record Key

34077ede-2a86-4329-931b-d9c5db23e56d

Public Version Date

October 23, 2019

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-