Catalog Number

-

Brand Name

Home Care

Version/Model Number

HT329L3(M3)

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"

-

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

K023000

Product Code

IPF

Product Code Name

Stimulator, Muscle, Powered

Public Device Record Key

cdc3f676-37ae-40c5-af1f-1c9a66d49142

Public Version Date

February 19, 2021

Public Version Number

7

DI Record Publish Date

December 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-