Catalog Number

-

Brand Name

Pohaku

Version/Model Number

AS8012

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

Yes

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

-

Product Code

NGX

Product Code Name

Stimulator, Muscle, Powered, For Muscle Conditioning

Public Device Record Key

ed21e5ab-8662-427d-a3a4-7664a8185d43

Public Version Date

February 28, 2020

Public Version Number

1

DI Record Publish Date

February 20, 2020

Package DI Number

16972929600009

Quantity per Package

48

Contains DI Package

06972929600002

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton box