Catalog Number

-

Brand Name

Compressible Limb Therapy System(LX7(V7))

Version/Model Number

ACg0410-2

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,K102320

Product Code

IRP

Product Code Name

Massager, Powered Inflatable Tube

Public Device Record Key

293f750c-df58-46e3-8537-431b2f2c5ae6

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 04, 2016

Package DI Number

28809315677862

Quantity per Package

20

Contains DI Package

08809315677868

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box