Catalog Number

410201

Brand Name

BEMER Therapy Systems

Version/Model Number

Professional

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)

-

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

6dbf84ab-0a9e-4dd4-8b38-b6095e200ea7

Public Version Date

February 28, 2020

Public Version Number

3

DI Record Publish Date

May 03, 2017

Package DI Number

07640161461062

Quantity per Package

1

Contains DI Package

07640161461055

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-