FDA.reportPublic FDA data

Motive Knee System

Primary DI
00850022650352
Brand
Motive Knee System
Company
Motive Health, Inc.
Model
OT02-1002
Catalog number
OT02-1002
Device description
MOTIVE THERAPY PAD (LEFT), 1 MONTH BUNDLE
Published
2023-08-03
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850022650352PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850022650352008500226503528500226503520850022650352

GMDN Terms#

Term, Definition table
TermDefinition
Electrode conductive mediumA non-sterile substance intended to be used as a medium for the efficient transmission of electrical signals between an electrode and the body, and for the reduction of the isolation properties of the skin. It is typically in the form of a gel, paste, spray or cream and is usually used in electrocardiography, defibrillation and diathermy. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8.58Inch

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
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
00850022650451Motive Knee SystemOT01-2001OT01-20012024-08-12
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
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
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
00850055335004iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
00850055335011iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
00850055335028iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
08057971594733Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-18
08720791375911CadwellTechnomed Engineering B.V.GXY2025-03-12
08057971592685Wave ElectrodeBIONIT LABS SRLGXY2025-01-21
08720791377564NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791377595NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791375591CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375614CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375638CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375652CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375676CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791374426NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374440NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374457NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374471NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374495NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374518NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374532NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374556NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374693MagstimTechnomed Engineering B.V.GXY2024-05-22
08720791372125CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372149CadwellTechnomed Engineering B.V.GXY2024-05-02