FDA.reportPublic FDA data

MySPM@Home App

Primary DI
08051122040933
Brand
MySPM@Home App
Company
NCS LAB SRL
Model
SPM01A2
Catalog number
SPM01A2
Device description
Optionally, the electrostimulator (SPM01M1) can require the combined use with the MySPM@Home mobile application, as accessory of the Subject device. It allows to monitor the user and guide rehabilitation and training through specific protocols.
Published
2021-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HCCDevice, Biofeedback
IPFStimulator, Muscle, Powered
KQXGoniometer, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2
IPFStimulator, Muscle, PoweredPhysical Medicine2
KQXGoniometer, Ac-PoweredOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08051122040933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08051122040933080511220409338051122040933

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered unit intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
429763668
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08051122041138Elite Spk inserterP005_AS034_132022-06-09
08051122040988GT TUNNELERGTTN00M12022-06-03
08051122041091Software web ShowmotionSHWM01SW12022-03-14
08051122040902Shoulder Pacemaker deviceSPM01M1SPM01M12021-09-01
08051122040919Shoulder Pacemaker device (wireless PC)SPM01M2SPM01M22021-09-01
08051122040926MySPM AppSPM01A1SPM01A12021-09-01
08051122040940Stand-alone mode KitSPM01K1SPM01K12021-09-01
08051122040957Wireless mode - KitSPM01K2SPM01K22021-09-01
08051122040964Wireless app mode - KitSPM01K3SPM01K32021-09-01
08051122040971Wireless app home mode - KitSPM01K4SPM01K42021-09-01
08051122041190Taylor Stitcher Sterilization basketP005_AS034_092022-06-09
08051122040698TAYLOR STITCHERP005_AS0342022-06-09
08051122041121Taylor Stitcher bodyP005_AS034_012022-06-09
08051122041145Taylor Stitcher PunchP005_AS034_032022-06-09
08051122041152Taylor Stitcher ScrewdriverP005_AS034_042022-06-09
08051122041169Taylor Stitcher Targeting systemP005_AS034_052022-06-09
08051122041176Taylor Stitcher Screw ring main bodyP005_AS034_062022-06-09
08051122041183Taylor Stitcher ScrewsP005_AS034_082022-06-09
08051122041206Taylor Stitcher HammerP005_AS034_122022-06-09
08051122041213Taylor Stitcher Spanner 7mmP005_AS034_162022-06-09

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