POWER PLAY - CALF MASSAGE WRAPS - COMPRESSION SOLUTIONS, LLC

Duns Number:879909877

Device Description: CALF MASSAGE WRAPS

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More Product Details

Catalog Number

-

Brand Name

POWER PLAY

Version/Model Number

PPCW33

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K122154

Product Code Details

Product Code

IRP

Product Code Name

MASSAGER, POWERED INFLATABLE TUBE

Device Record Status

Public Device Record Key

aab779b4-c606-4d26-a1f2-1e55bf57351b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 04, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COMPRESSION SOLUTIONS, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 21