XBody - The XBody Newave USA is a machine with electronic - XBODY HUNGARY Kft.

Duns Number:366728377

Device Description: The XBody Newave USA is a machine with electronic muscle stimulation based on EMS technolo The XBody Newave USA is a machine with electronic muscle stimulation based on EMS technology. The device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes.

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More Product Details

Catalog Number

-

Brand Name

XBody

Version/Model Number

Newave USA

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"

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For Single-Use

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Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K190038

Product Code Details

Product Code

NGX

Product Code Name

Stimulator, Muscle, Powered, For Muscle Conditioning

Device Record Status

Public Device Record Key

1275a0ee-d74b-41a0-94dd-6a5d300aa948

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

July 31, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"XBODY HUNGARY KFT." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1