Incline Platform Lift - X3 - Permanently mounted wheelchair platform lift - Garaventa (Canada) Ltd

Duns Number:252287586

Device Description: X3 - Permanently mounted wheelchair platform lift

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More Product Details

Catalog Number

-

Brand Name

Incline Platform Lift

Version/Model Number

05

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K122206

Product Code Details

Product Code

PCE

Product Code Name

Permanently Mounted Wheelchair Platform Lift

Device Record Status

Public Device Record Key

590db7d4-7729-4890-b97d-c10d7fad1c3a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 28, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GARAVENTA (CANADA) LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 8