Catalog Number

-

Brand Name

Compression Therapy Device

Version/Model Number

LGT-2200SP

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K191862

Product Code

IRP

Product Code Name

Massager, Powered Inflatable Tube

Public Device Record Key

9412c4ce-550f-4e5f-8cc9-3e3ebb7195fc

Public Version Date

November 11, 2019

Public Version Number

1

DI Record Publish Date

November 03, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-