FDA.reportPublic FDA data

Motive Knee System

Primary DI
00850022650451
Brand
Motive Knee System
Company
Motive Health, Inc.
Model
OT01-2001
Catalog number
OT01-2001
Device description
Motive Knee System, Right, Standard
Published
2024-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous
IPFStimulator, Muscle, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2
IPFStimulator, Muscle, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850022650451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850022650451008500226504518500226504510850022650451

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered device assembly 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length39.9Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-13 Degrees Fahrenheit158 Degrees Fahrenheit
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-13 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-668-4838support@mymotive.com

Regulatory Flags#

DUNS number
035596579
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850022650536Motive Conductive Gel TubeOT03-1002OT03-10022025-11-28
00850022650543Motive Lower Back SystemOT01-1003OT01-10032025-11-28
00850022650550Motive Lower Back 4-Pack BundleOT02-3000OT02-30002025-11-28
00850022650444Motive Knee SystemOT01-2000OT01-20002024-08-12
00850022650468Motive Knee SystemOT01-2002OT01-20022024-08-12
00850022650291Motive Knee SystemOT07-1002OT07-10022024-04-11
00850022650376Motive Knee SystemOT02-1004OT02-10042024-04-11
00850022650383Motive Knee SystemOT03-1001OT03-10012024-04-11
00850022650420Motive Knee SystemOT06-1000OT06-10002024-04-11
00850022650437Motive Knee SystemOT07-1000OT07-10002024-04-11
00850022650260Motive Knee SystemOT01-1000OT01-10002023-08-03
00850022650338Motive Knee SystemOT01-1001OT01-10012023-08-03
00850022650345Motive Knee SystemOT01-1002OT01-10022023-08-03
00850022650352Motive Knee SystemOT02-1002OT02-10022023-08-03
00850022650369Motive Knee SystemOT02-1003OT02-10032023-08-03
00850022650390Motive Knee SystemOT04-1002OT04-10022023-08-03
00850022650406Motive Knee SystemOT04-1003OT04-10032023-08-03
00850022650413Motive Knee SystemOT04-1004OT04-10042023-08-03
00850022650000e-vive II NMES System with Post-Op Brace; S/M, Right (ITALIAN)CY-1000-307ICY-1000-307I2021-01-04
00850022650017e-vive II NMES System with Post-Op Brace; L/XL, Right (ITALIAN)CY-1000-308ICY-1000-308I2021-01-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973602730894MEDLOTTOP-RANK HEALTH CARE CO., LTD.GXY2026-06-08
G345SL2000CIONICCionic, Inc.IPF2026-06-04
08720791379032Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379049Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379063Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379087Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
00816312028072Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXY2026-06-01
03770018808086actiTENSSUBLIMEDIPF2026-05-27
03770018808093actiTENSSUBLIMEDIPF2026-05-27
03770018808109actiTENSSUBLIMEDIPF2026-05-27
03770018808116actiTENSSUBLIMEDIPF2026-05-27
03770018808253actiTENS MiniSUBLIMEDIPF2026-05-27
03770018808260actiTENS MiniSUBLIMEDIPF2026-05-27
08809308380041Talent-pro Electromagnetic StimulatorREMED Co.,Ltd.IPF2026-05-13
00850055335004iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
00850055335011iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
00850055335028iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
07898966442551IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
07898966442698IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
08057971594733Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-18
08032625824480GLOBUSDOMINO SRLIPF2026-02-23
08885022060018Quantum Mitohormesis (QMT)QUANTUMTX PTE. LTD.IPF2025-07-21
08720791375911CadwellTechnomed Engineering B.V.GXY2025-03-12
08720618311139Sonopuls 494Enraf-Nonius B.V.IPF2025-02-11
08057971592685Wave ElectrodeBIONIT LABS SRLGXY2025-01-21
08720791377564NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791377595NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08032625822868GLOBUSDOMINO SRLIPF2024-11-20
08032625822875GLOBUSDOMINO SRLIPF2024-11-20
08032625822882GLOBUSDOMINO SRLIPF2024-11-20