Catalog Number

-

Brand Name

Flyte In-Home Pelvic Floor Treatment

Version/Model Number

MTI-1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K200409

Product Code

HIR

Product Code Name

Perineometer

Public Device Record Key

6c5dee8a-4b51-4fbe-84dd-2c55e097d2f8

Public Version Date

August 12, 2021

Public Version Number

1

DI Record Publish Date

August 04, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-