Catalog Number

-

Brand Name

WONJIN

Version/Model Number

POWER-Q2300

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

K100656,K100656,K100656,K100656,K100656

Product Code

IRP

Product Code Name

Massager, Powered Inflatable Tube

Public Device Record Key

54579ee2-58cf-43f3-bc6c-7f34f3bd3502

Public Version Date

January 19, 2022

Public Version Number

1

DI Record Publish Date

January 11, 2022

Package DI Number

18809277423470

Quantity per Package

1

Contains DI Package

08809277423466

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-