Curble Chair - Posture correct orthosis with lumbar support - ablue.Co.,Ltd

Duns Number:689519029

Device Description: Posture correct orthosis with lumbar support

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More Product Details

Catalog Number

-

Brand Name

Curble Chair

Version/Model Number

K-Med_Small_Mint

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 15, 2021

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

Yes

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

-

Product Code Details

Product Code

IQE

Product Code Name

Orthosis, Lumbar

Device Record Status

Public Device Record Key

e5abae71-573f-447b-82de-62401b3d99b8

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

October 14, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ABLUE.CO.,LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 42