Wireless mode - Kit SPM01K2

GUDID 08051122040957

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.

NCS LAB SRL

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Primary Device ID08051122040957
NIH Device Record Keydd0da7fb-81e6-41c4-b30b-16d06d4fac23
Commercial Distribution StatusIn Commercial Distribution
Brand NameWireless mode - Kit
Version Model NumberSPM01K2
Catalog NumberSPM01K2
Company DUNS429763668
Company NameNCS LAB SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108051122040957 [Primary]

FDA Product Code

IPFStimulator, Muscle, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-11-29
Device Publish Date2021-09-01

Devices Manufactured by NCS LAB SRL

08051122040902 - Shoulder Pacemaker device2022-11-29 The configuration is composed of an electrostimulator and other components, useful for recharging, wearing, stimulating and/or c
08051122040919 - Shoulder Pacemaker device (wireless PC)2022-11-29 The configuration is composed of an electrostimulator and other components, useful for recharging, wearing, stimulating and/or c
08051122040926 - MySPM App2022-11-29 Optionally, the electrostimulator (SPM01M1) can require the combined use with the MySPM mobile application, as accessory of the
08051122040933 - MySPM@Home App2022-11-29 Optionally, the electrostimulator (SPM01M1) can require the combined use with the MySPM@Home mobile application, as accessory of
08051122040940 - Stand-alone mode Kit2022-11-29 For the stand-alone mode version of the subject device, the SPM01K1 convenience kit includes: 1 electrostimulator SPM01M1 confi
08051122040957 - Wireless mode - Kit2022-11-29For 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.
08051122040957 - Wireless mode - Kit2022-11-29 For the wireless mode version of the subject device, to be used in combination with a dedicated control software running on a pc
08051122040964 - Wireless app mode - Kit2022-11-29 For the wireless mode version of the subject device, to be used in combination with an application installed on a tablet, the SP
08051122040971 - Wireless app home mode - Kit2022-11-29 For the wireless mode version of the subject device, combined with an application installed on a tablet that can be used in a ho
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