Assembly Required Distributors - WC 20" seat width, 16" seat depth, flip-up - ASSEMBLY REQUIRED DISTRIBUTORS INC

Duns Number:170562396

Device Description: WC 20" seat width, 16" seat depth, flip-up arm,detachable footrests, w/ black/gray nylon WC 20" seat width, 16" seat depth, flip-up arm,detachable footrests, w/ black/gray nylon open weave seat and back, plastic a/r 350lb capacityF-051SSWC

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More Product Details

Catalog Number

-

Brand Name

Assembly Required Distributors

Version/Model Number

INV01426

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

K973418

Product Code Details

Product Code

IOR

Product Code Name

Wheelchair, Mechanical

Device Record Status

Public Device Record Key

3bfd3d51-4d4a-4abf-a986-b234a53b1555

Public Version Date

September 12, 2019

Public Version Number

1

DI Record Publish Date

September 04, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ASSEMBLY REQUIRED DISTRIBUTORS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 81
2 A medical device with a moderate to high risk that requires special controls. 8