FDA.reportPublic FDA data

Roscoe Medical

Primary DI
00092237612859
Brand
Roscoe Medical
Company
Drive Devilbiss Healthcare
Model
DN4055
Device description
IF 4K - Digital Interferential
Published
2016-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LIHInterferential Current Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIHInterferential Current TherapyNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
80092237612855PackageGS124In Commercial Distribution
00092237612859PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
8009223761285580092237612855
00092237612859000922376128590922376128590092237612859

GMDN Terms#

Term, Definition table
TermDefinition
Interferential electrical stimulation systemAn electrically-powered device assembly designed to stimulate peripheral nerves through the transcutaneous application of two currents of slightly different frequencies (e.g., 4000 and 4100 Hz) that cross-over/interfere, producing a beating frequency (i.e., difference between the frequencies of both stimuli) at the treatment point. It typically consists of an external pulse generator and a set of electrodes placed in position to produce the interference at the desired point. The system is used mainly to relieve/manage intractable pain; some include additional electrodes to provide other types of electrical stimuli or suction for therapeutic massage.

Contacts#

Phone, Email table
PhoneEmail
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags#

DUNS number
867673159
Device count
1
Kit
true
Serial number
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00714905710024Fab StimDrive Devilbiss HealthcareLIH2026-02-06
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00858563006256MAX-IFBIOPROTECH INC.LIH2025-10-13
00860012519507CPS-2000SURGITECH, INC.LIH2025-03-31
08032625822868GLOBUSDOMINO SRLLIH2024-11-20
08032625822875GLOBUSDOMINO SRLLIH2024-11-20
08032625822882GLOBUSDOMINO SRLLIH2024-11-20
08032625822851GLOBUSDOMINO SRLLIH2024-10-17
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08032625829799GLOBUSDOMINO SRLLIH2024-10-17
08032625829805GLOBUSDOMINO SRLLIH2024-10-17
08032625829812GLOBUSDOMINO SRLLIH2024-10-17
00860012846917HakomedHAKOMED ASIA COMPANY LIMITEDLIH2024-10-08
08032625822837GLOBUSDOMINO SRLLIH2024-09-04
08032625822844GLOBUSDOMINO SRLLIH2024-09-04
08032625825265GLOBUSDOMINO SRLLIH2024-09-04
08032625828020GLOBUSDOMINO SRLLIH2024-09-04
04260364812053HiTop 4touchgbo Medizintechnik AGLIH2024-08-05
04260364812060HiTop 2touchgbo Medizintechnik AGLIH2024-08-05
04260364812077HiTop 1touchgbo Medizintechnik AGLIH2024-08-05
06971763600506ROOVJOYShenzhen roundwhale technology co. LTD.LIH2024-07-31
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00817717023099VQ OrthoCareVision Quest Industries IncorporatedLIH2024-03-28
06942808291478IF-4 MultiWaveEasyMed Instruments Co., Ltd.LIH2024-01-19
00859718007289Flex-MI with ElectrodesEmsiLIH2023-09-20
00859718007272Flex-MIEmsiLIH2023-09-19
04712832961188GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-09-04
04712832961256GEM-STIMGEMORE TECHNOLOGY CO., LTD.LIH2023-09-04