Catalog Number

-

Brand Name

TEC.BEAN

Version/Model Number

AS1080

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 04, 2021

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

851d458a-12a2-4ef0-ad0d-8619d42bc5c7

Public Version Date

September 05, 2022

Public Version Number

9

DI Record Publish Date

September 19, 2017

Package DI Number

06970890329283

Quantity per Package

30

Contains DI Package

06970890320011

Package Discontinue Date

May 04, 2021

Package Status

Not in Commercial Distribution

Package Type

carton