Catalog Number

FA7-1400J

Brand Name

7LS

Version/Model Number

FA7-1400J

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

K162106

Product Code

NFO

Product Code Name

Stimulator, Transcutaneous Electrical, Aesthetic Purposes

Public Device Record Key

5af25514-d370-4e2d-9ba7-fab8755a3109

Public Version Date

March 09, 2020

Public Version Number

1

DI Record Publish Date

February 29, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-