Catalog Number

-

Brand Name

POWER-Q1000

Version/Model Number

WHF-314

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

K080134,K080134,K080134,K080134,K080134

Product Code

IRP

Product Code Name

Massager, Powered Inflatable Tube

Public Device Record Key

73de95ae-3631-4bb2-87df-cdaaf92ead48

Public Version Date

January 04, 2022

Public Version Number

4

DI Record Publish Date

August 19, 2016

Package DI Number

28809277426027

Quantity per Package

2

Contains DI Package

18809277426020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton box