Skippi Power Wheelchair for Children - Otto Bock Mobility Solutions GmbH

Duns Number:341148586

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More Product Details

Catalog Number

-

Brand Name

Skippi Power Wheelchair for Children

Version/Model Number

490E55=00000_K

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 18, 2020

Issuing Agency

In GS1

Product Characteristics

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

K070318

Product Code Details

Product Code

ITI

Product Code Name

Wheelchair, Powered

Device Record Status

Public Device Record Key

90b47dc8-965e-45ee-acb2-4d7b1b2fae6e

Public Version Date

September 16, 2020

Public Version Number

4

DI Record Publish Date

September 14, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OTTO BOCK MOBILITY SOLUTIONS GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7