Catalog Number

-

Brand Name

POWER-Q1000PREMIUM

Version/Model Number

POWER-Q1000PREMIUM

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

K113275,K113275,K113275,K113275,K113275

Product Code

IRP

Product Code Name

Massager, Powered Inflatable Tube

Public Device Record Key

25174fca-7c92-4938-accd-416ca10c06e1

Public Version Date

December 28, 2021

Public Version Number

5

DI Record Publish Date

August 19, 2016

Package DI Number

38809277420442

Quantity per Package

3

Contains DI Package

18809277420448

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton box