FDA.reportPublic FDA data

WINNER EVO PACKAGE

Primary DI
00850958007978
Brand
WINNER EVO PACKAGE
Company
Drive Devilbiss Healthcare
Model
410-010
Device description
CM2, THERAPY HAMMER, LASER MODULE, 2X2 MS CLOTH, LEAD CORDS, 5CM GELSHOTS & ADAPTOR
Published
2016-11-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
ILYLamp, Infrared, Therapeutic Heating
IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat
IPFStimulator, Muscle, Powered
LIHInterferential Current Therapy
MUIMedia,Coupling,Ultrasound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2
IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep HeatPhysical Medicine2
IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep HeatPhysical Medicine2
IPFStimulator, Muscle, PoweredPhysical Medicine2
LIHInterferential Current TherapyNeurology2
MUIMedia, Coupling, UltrasoundRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850958007978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850958007978008509580079788509580079780850958007978

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrodeA non-sterile electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation, cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-459-4945customerservice@richmarweb.com
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags#

DUNS number
867673159
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10092237600105Roscoe MedicalEP4070WCD2016-10-18
90002360125501AccuReliefACRL-55002016-10-12
00009223761699Reliable MedicalEF2020BC2-TU2018-06-13
00009223761941EswallowESW-90502016-12-31
00023601005144CAREX HEALTH BRANDSFGA51400 00002022-12-20
00023601005151CAREX HEALTH BRANDSFGA51500 BLUE2022-12-20
00023601005168CAREX HEALTH BRANDSFGA51600 GRN2022-12-20
00023601005175CAREX HEALTH BRANDSFGA51700 BRNZ2022-12-20
00023601005182CAREX HEALTH BRANDSFGA51800 GRAY2022-12-20
00023601007117CAREX HEALTH BRANDSFGA71100 00002023-03-15
00023601007179CAREX HEALTH BRANDSFGA71700 00002023-03-15
00023601007186CAREX HEALTH BRANDSFGA71800 00002023-03-15
00023601007193CAREX HEALTH BRANDSFGA71900 00002023-03-15
00023601012210Carex Health BrandsFGA22100 00002022-12-09
00023601012227CAREX HEALTH BRANDSFGA22200 00002022-12-12
00023601012234CAREX HEALTH BRANDSFGA22300 00002022-12-12
00023601012302CAREX HEALTH BRANDSFGA23000 00002022-12-12
00023601012319CAREX HEALTH BRANDSFGA23177 00002022-12-12
00023601012333CAREX HEALTH BRANDSFGA23300 00002022-12-12
00023601013330CAREX HEALTH BRANDSFGA33300 00002022-12-12

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Primary DI, Brand, Company table
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07898966442551IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
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10197344130252MEDLINEMEDLINE INDUSTRIES, INC.MUI2026-04-09
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08032625824480GLOBUSDOMINO SRLLIH2026-02-23
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08906172600074LightdoctorLIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDILY2025-10-10
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08885022060018Quantum Mitohormesis (QMT)QUANTUMTX PTE. LTD.IPF2025-07-21
08809851470091EVE Synergy; EVE TitanWEERO Co., Ltd.GZJ2025-06-24
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08720618311139Sonopuls 494Enraf-Nonius B.V.IMG2025-02-11
08057971592685Wave ElectrodeBIONIT LABS SRLGXY2025-01-21
10197106849064CARDINAL HEALTHCardinal Health 200, LLCMUI2025-01-09
08720791377564NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791377595NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08032625822868GLOBUSDOMINO SRLLIH2024-11-20
08032625822868GLOBUSDOMINO SRLIPF2024-11-20
08032625822875GLOBUSDOMINO SRLLIH2024-11-20