Catalog Number

-

Brand Name

WELL-LIFE

Version/Model Number

WL-2407

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 25, 2019

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K063660

Product Code

LIH

Product Code Name

Interferential Current Therapy

Public Device Record Key

482d05dd-3755-4354-99ca-0f5953b88e5e

Public Version Date

May 23, 2019

Public Version Number

8

DI Record Publish Date

April 25, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-