Catalog Number

-

Brand Name

Air Relax Plus Model AR-3.0 Control Unit Only

Version/Model Number

AR3

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K211460

Product Code

IRP

Product Code Name

Massager, Powered Inflatable Tube

Public Device Record Key

f27b47ae-1df4-466c-aa9f-dc8ed0a35d03

Public Version Date

July 23, 2021

Public Version Number

1

DI Record Publish Date

July 15, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-