e-motion® - Alber GmbH

Duns Number:340348858

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More Product Details

Catalog Number

-

Brand Name

e-motion®

Version/Model Number

M25

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K192618

Product Code Details

Product Code

ITI

Product Code Name

Wheelchair, Powered

Device Record Status

Public Device Record Key

7827e870-3aef-44ce-b049-fc74190db642

Public Version Date

March 04, 2021

Public Version Number

1

DI Record Publish Date

February 24, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ALBER GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 199