MODULAR POWER POSITIONING SYSTEM - DROP SEAT - MAXX RAIL - Motion Concepts Inc

Duns Number:259777209

Device Description: DROP SEAT - MAXX RAIL

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More Product Details

Catalog Number

-

Brand Name

MODULAR POWER POSITIONING SYSTEM

Version/Model Number

45T-10L-RPSB-MAXX

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

K150574

Product Code Details

Product Code

ITI

Product Code Name

Wheelchair, Powered

Device Record Status

Public Device Record Key

77b6008c-8207-4578-a33c-a9cee89f0646

Public Version Date

August 20, 2021

Public Version Number

1

DI Record Publish Date

August 12, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MOTION CONCEPTS INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 176