CTM Mobility Scooter - Folding Scooter, Red/Sky Blue/Orange/Fine White - C.T.M. HOMECARE PRODUCT, INC.

Duns Number:043045660

Device Description: Folding Scooter, Red/Sky Blue/Orange/Fine White

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More Product Details

Catalog Number

-

Brand Name

CTM Mobility Scooter

Version/Model Number

HS-268

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 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

-

Product Code Details

Product Code

INI

Product Code Name

Vehicle, Motorized 3-Wheeled

Device Record Status

Public Device Record Key

12afd18a-2392-46c5-ab8e-03bdbe1e52be

Public Version Date

March 19, 2021

Public Version Number

2

DI Record Publish Date

January 14, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"C.T.M. HOMECARE PRODUCT, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 20