Catalog Number

-

Brand Name

Compressible Limb Therapy System

Version/Model Number

LX7(V7)

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

K102320,K102320

Product Code

IRP

Product Code Name

Massager, Powered Inflatable Tube

Public Device Record Key

15077091-44a1-4f9e-8c65-33e7319ec942

Public Version Date

July 20, 2018

Public Version Number

1

DI Record Publish Date

June 19, 2018

Package DI Number

28809315678357

Quantity per Package

2

Contains DI Package

18809315678350

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box