FDA.reportPublic FDA data

MySPM App

Primary DI
08051122040926
Brand
MySPM App
Company
NCS LAB SRL
Model
SPM01A1
Catalog number
SPM01A1
Device description
Optionally, the electrostimulator (SPM01M1) can require the combined use with the MySPM 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
08051122040926PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08051122040926080511220409268051122040926

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
08051122040933MySPM@Home AppSPM01A2SPM01A22021-09-01
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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Primary DI, Brand, Company table
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00860015825803JOGO-GxJogohealth, Inc.HCC2026-07-27
00860007286513KinetigramBioniksKQX2026-07-22
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-09
06971712722693DOMASHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-09
07540191000678NeuroInfinitiThought Technology Ltd.HCC2026-07-06
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-03
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03770018808109actiTENSSUBLIMEDIPF2026-05-27
03770018808116actiTENSSUBLIMEDIPF2026-05-27
03770018808253actiTENS MiniSUBLIMEDIPF2026-05-27
03770018808260actiTENS MiniSUBLIMEDIPF2026-05-27
04048223122235Stim2GoPajunk GmbH MedizintechnologieIPF2026-05-21
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07898966442551IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
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