Catalog Number

RF1430

Brand Name

Movement and Compressions System (MAC)

Version/Model Number

B

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

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

K203052

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

18d24d20-dd3f-4fa2-89d9-6d0165886ab0

Public Version Date

May 10, 2021

Public Version Number

2

DI Record Publish Date

April 05, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-