Catalog Number

-

Brand Name

TEC.BEAN

Version/Model Number

AS1080

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 14, 2022

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

K143268,K143268

Product Code

NGX

Product Code Name

Stimulator, Muscle, Powered, For Muscle Conditioning

Public Device Record Key

3db1f858-0fed-4bb2-afaf-9152ae381cfa

Public Version Date

October 14, 2022

Public Version Number

11

DI Record Publish Date

August 29, 2017

Package DI Number

06970890328963

Quantity per Package

32

Contains DI Package

06970890320028

Package Discontinue Date

July 02, 2021

Package Status

Not in Commercial Distribution

Package Type

Carton