SuperStand Standing Wheelchair - Full-power, power to drive and power to stand, - STANDING COMPANY, THE

Duns Number:557086410

Device Description: Full-power, power to drive and power to stand, standing wheelchair

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More Product Details

Catalog Number

-

Brand Name

SuperStand Standing Wheelchair

Version/Model Number

PS-2

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

K032101

Product Code Details

Product Code

IPL

Product Code Name

Wheelchair, Standup

Device Record Status

Public Device Record Key

bf3d0f7c-6ef4-4932-983c-d6f337b9798c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STANDING COMPANY, THE" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4