FDA.reportPublic FDA data

INF 4160C

Primary DI
04897079950017
Brand
INF 4160C
Company
BRACEMART, LLC
Model
1
Published
2016-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
LIHInterferential Current Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIHInterferential Current TherapyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092780000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092780000INF 4160 PLUS, MODEL D-FJ31FFuji Dynamics Limited2010-01-07LIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14897079950014PackageGS124In Commercial Distribution
04897079950017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1489707995001414897079950014
04897079950017048970799500174897079950017

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

Regulatory Flags#

DUNS number
055605293
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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08032625824480GLOBUSDOMINO SRLLIH2026-02-23
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00714905710024Fab StimDrive Devilbiss HealthcareLIH2026-02-06
00860163000312CMS Drive Devilbiss HealthcareLIH2026-02-06
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
08032625828037GLOBUSDOMINO SRLLIH2024-10-17
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
06971763600674ROOVJOYShenzhen roundwhale technology co. LTD.LIH2024-07-31
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