Wireless mode - Kit - For the wireless mode version of the subject - NCS LAB SRL

Duns Number:429763668

Device Description: For the wireless mode version of the subject device, to be used in combination with a dedi For the wireless mode version of the subject device, to be used in combination with a dedicated control software running on a pc/laptop, the content of the SPM01K2 convenience kit is: 1 electrostimulator SPM01M2 configuration; electrodes, and protective skin.

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More Product Details

Catalog Number

SPM01K2

Brand Name

Wireless mode - Kit

Version/Model Number

SPM01K2

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

K210674

Product Code Details

Product Code

IPF

Product Code Name

Stimulator, Muscle, Powered

Device Record Status

Public Device Record Key

dd0da7fb-81e6-41c4-b30b-16d06d4fac23

Public Version Date

September 09, 2021

Public Version Number

1

DI Record Publish Date

September 01, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NCS LAB SRL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 22
2 A medical device with a moderate to high risk that requires special controls. 11