Vitalcontrol - ANKLE TENS DEVICE - BEURER NORTH AMERICA, L.P.

Duns Number:078497467

Device Description: ANKLE TENS DEVICE

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More Product Details

Catalog Number

664.72

Brand Name

Vitalcontrol

Version/Model Number

SEM22

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

K200838

Product Code Details

Product Code

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Device Record Status

Public Device Record Key

fea7f74b-2692-4415-bfcd-3fd3cff95dde

Public Version Date

August 09, 2021

Public Version Number

1

DI Record Publish Date

July 31, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BEURER NORTH AMERICA, L.P." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 90
U Unclassified 2