Compressible Limb Therapy System(LX7(V7)) - 4 Chamber Overlapping Half-leg (Medium) sleeve - DAESUNG MAREF CO.,LTD.

Duns Number:688817949

Device Description: 4 Chamber Overlapping Half-leg (Medium) sleeve with Hose

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Compressible Limb Therapy System(LX7(V7))

Version/Model Number

ACg0480

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 11, 2017

Issuing Agency

In GS1

Product Characteristics

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

Product Code Details

Product Code

IRP

Product Code Name

Massager, Powered Inflatable Tube

Device Record Status

Public Device Record Key

89b56550-c1fe-476a-840b-506e3c876268

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 11, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DAESUNG MAREF CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 175