Catalog Number

TM-L

Brand Name

ELECTROmatic TM-L

Version/Model Number

1.012.8546

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K163317

Product Code

EBW

Product Code Name

Controller, foot, handpiece and cord

Public Device Record Key

b23ccbc5-b99c-41e7-9dfc-486bc5422121

Public Version Date

November 08, 2021

Public Version Number

2

DI Record Publish Date

March 01, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-