FDA.reportPublic FDA data

e-vive NMES System; Small/Medium, Left (2.0 Dock)

Primary DI
00854691008414
Brand
e-vive NMES System; Small/Medium, Left (2.0 Dock)
Company
Motive Health, Inc.
Model
CY-1000-216
Catalog number
CY-1000-216
Device description
e-vive NMES System; Small/Medium, Left (2.0 Dock)
Published
2019-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GJZCyanomethemoglobin Reagent And Standard Solution
IPFStimulator, Muscle, Powered
KQXGoniometer, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GJZCyanomethemoglobin Reagent And Standard SolutionHematology2
IPFStimulator, Muscle, PoweredPhysical Medicine2
KQXGoniometer, Ac-PoweredOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163067000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163067000CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc.2016-12-01IPF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854691008414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854691008414008546910084148546910084140854691008414

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. 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
Length16Inch

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-25 Degrees Celsius70 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4806642547jackie.c@cymedicaortho.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
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
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

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Primary DI, Brand, Company table
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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
07898966442551IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
07898966442698IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
00816271020698UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271020803myoRESEARCHNoraxon U.S.A., Inc.KQX2026-03-30
00816271020865UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271020872UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021039UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021046UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021053UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021060UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021077UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021084UltiumNoraxon U.S.A., Inc.KQX2026-03-30
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00816271021145UltiumNoraxon U.S.A., Inc.KQX2026-03-30
08032625824480GLOBUSDOMINO SRLIPF2026-02-23
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