Catalog Number

S551

Brand Name

Quingo Flyte and Docking Station

Version/Model Number

MK2

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K170634

Product Code

INI

Product Code Name

Vehicle, Motorized 3-Wheeled

Public Device Record Key

b72cea15-9cae-4d57-a3be-c7acbac6d2c4

Public Version Date

January 24, 2020

Public Version Number

1

DI Record Publish Date

January 16, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-