FDA.reportPublic FDA data

N/A

Primary DI
80092237612855
Brand
N/A
Company
COMPASS HEALTH BRANDS CORP.
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
OTC
false
Sterile
false
Single use
false

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
440-572-1962CustomerService@compasshealthbrands.com
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags#

DUNS number
827221698
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30194346615156Equate 72085EQ2026-01-20
40076855700608Apex70060BPKG2025-08-28
30023601200519AccuReliefACRL-00512025-07-17
30092237628561TENS 7000DT7308-ELEC42025-07-10
30092237628554TENS 7000DT7307-ELEC82025-06-30
30023601088209CarexFGE82000 00002025-06-25
30627394040019Pain CakesTMF70001CA2025-06-03
30627394040057Pain CakesTMF70005CA2025-06-03
30627394040064Pain CakesTMF70006CA2025-06-03
30023601017100CAREX HEALTH BRANDSFGA71000 00002025-05-21
30627394023036CarexFGB303CA2025-05-13
50023601023037CarexFGB30300 00002025-02-19
80092237626845TENS 7000DT73152025-01-21
30092237626734TENS 7000DT73092025-01-06
30092237626741TENS 7000DT73102025-01-06
30092237626758TENS 7000DT73142025-01-06
30632615880107Bed BuddyBBF8010-122024-12-18
30023601261008AccuReliefACRL-52002024-12-17
30041520865817Apex70010AHO2024-12-09
30635515992765Apex70010QC2024-12-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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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08032625829805GLOBUSDOMINO SRLLIH2024-10-17
08032625829812GLOBUSDOMINO SRLLIH2024-10-17
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08032625828020GLOBUSDOMINO SRLLIH2024-09-04
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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