CTM - Heavy Duty Rear-Wheel Drive Power Chair - CHIEN TI ENTERPRISE CO., LTD.

Duns Number:656139839

Device Description: Heavy Duty Rear-Wheel Drive Power Chair

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More Product Details

Catalog Number

-

Brand Name

CTM

Version/Model Number

HS-5600

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

ITI

Product Code Name

Wheelchair, Powered

Device Record Status

Public Device Record Key

367ce167-27fa-425e-9e96-d81fb71d3936

Public Version Date

March 26, 2021

Public Version Number

1

DI Record Publish Date

March 18, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CHIEN TI ENTERPRISE CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 12