Posture-Mate - 2219 Posture-Mate HB/WC Left or Right Universal - IMMERSUS HEALTH COMPANY, LLC

Duns Number:080627691

Device Description: 2219 Posture-Mate HB/WC Left or Right Universal Arm Padded Arm Cover for wheelchair

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More Product Details

Catalog Number

2219

Brand Name

Posture-Mate

Version/Model Number

HB/WC Left or Right Universal Padded arm cover for wheelchair

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

February 19, 2040

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

IMP

Product Code Name

Cushion, Wheelchair

Device Record Status

Public Device Record Key

19b61e18-44b1-4bad-a6ef-cd484411b4c1

Public Version Date

May 10, 2021

Public Version Number

2

DI Record Publish Date

February 20, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IMMERSUS HEALTH COMPANY, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 71