Pulse Pro Upper and Lower Body Recovery Package - Pulse Pro Recovery Package - Upper and Lower Body - NORMATEC INDUSTRIES LP

Duns Number:111448069

Device Description: Pulse Pro Recovery Package - Upper and Lower Body Power Tall

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More Product Details

Catalog Number

40235

Brand Name

Pulse Pro Upper and Lower Body Recovery Package

Version/Model Number

Pulse Pro Recovery Package - Upper and Lower Body Power Tall

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K160608

Product Code Details

Product Code

IRP

Product Code Name

Massager, Powered Inflatable Tube

Device Record Status

Public Device Record Key

8c88bf94-21bc-44ae-ad7b-944a1f518c98

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 13, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NORMATEC INDUSTRIES LP" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 202