Catalog Number

-

Brand Name

Portable Electro-Stimulation Therapy Device

Version/Model Number

LGT-233

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"

Yes

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

K202110

Product Code

GZI

Product Code Name

Stimulator, Neuromuscular, External Functional

Public Device Record Key

81969546-a045-44ff-86b4-5e4f7090bb22

Public Version Date

December 10, 2021

Public Version Number

1

DI Record Publish Date

December 02, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-