Catalog Number

-

Brand Name

BTL EMSELLA

Version/Model Number

BTL EMSELLA

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

-

Product Code

KPI

Product Code Name

Stimulator, Electrical, Non-Implantable, For Incontinence

Public Device Record Key

f26b6317-ac83-4f31-994b-ce8a8ed4db1c

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

February 25, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-