AXUS ES-5

Primary DI
14897076720092
Brand
AXUS ES-5
Company
TENS PLUS INDUSTRIAL COMPANY
Model
ED3930
Catalog number
ED3930
Device description
The AXUS ES-5 is an electro-acupuncture device indicated for use in the practice of acupuncture by qualified professionals of acupuncture as determined by the state. The AXUS ES-5 is a battery operated prescription use only electro-acupuncture device used for applying electric stimuli to areas of preferred delivery (APD). The device uses a low-intensity, low-frequency pulse multimode generator through micro-alligator clips attached to commercially available and FDA-cleared stainless steel acupuncture needles. The device can also deliver stimulation with the included probe.
Published
2021-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BWKStimulator, Electro-Acupuncture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWKStimulator, Electro-AcupunctureUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200636000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200636000AXUS ES-5 Electro-Acupuncture DeviceLhasa Oms, Inc.2021-02-03BWK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14897076720092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1489707672009214897076720092

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic transcutaneous electrical nerve stimulation systemAn assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-722-8775info@lhasaoms.com

Regulatory Flags#

DUNS number
663211978
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14897076721495PULSE PAD LARGE SIZEPulse.Pad.L2022-11-14
14897076721501PULSE PADPulse.Pad2022-11-14
14897076720146GB-3GD5208GD52082021-03-30
14897076723536E-Stim IIIED3981ED39812024-12-10
14897076721457Lion.Warm.XLGY53362023-06-05
14897076721655Multi.D.1.5MD28022023-06-05
14897076721815Moxa.Bx.BamSGY53372023-06-05
14897076721822Moxa.Bx.BamLGY53382023-06-05
14897076721853PistolDY09502023-06-05
14897076721860Pistol.LongDY21112023-06-05
14897076721877Ins.MP.SMD26112023-06-05
14897076721884Ins.MP.MMD26122023-06-05
14897076721891Ins.MP.LMD26132023-06-05
14897076722263Guasha.SBY26082023-06-05
14897076722270Guasha.MBY26092023-06-05
14897076722287Guasha.LBY26102023-06-05
14897076722454Tiger.Warm.SGY53672023-06-05
14897076722546Tiger.Warm.SGY53672023-06-05
14897076722577Bio.N.2MD28632023-06-05
14897076722614Ring.FingerMY26022023-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00768627017152Blue Diamond 360 Needle Stimulator Lead Wires - Alligator ClipNORTH COAST MEDICAL, INC.BWK2026-06-01
00768627017169Blue Diamond 360 Needle Stimulator Lead Wires - PigtailNORTH COAST MEDICAL, INC.BWK2026-06-01
06973774194265QIJIUBozhou Rongjian Medical Appliance Co., Ltd.BWK2026-04-03
08908006064281ANSiSTIM-PP NEUROSTIMULATION MEDTECH PRIVATE LIMITEDBWK2026-03-16
06932307410395JIAJIANWuxi Jiajian Medical Instrument Co.,Ltd.BWK2026-03-04
06932307410401JIAJIANWuxi Jiajian Medical Instrument Co.,Ltd.BWK2026-03-04
06932307410449JIAJIANWuxi Jiajian Medical Instrument Co.,Ltd.BWK2026-03-04
06932307410456JIAJIANWuxi Jiajian Medical Instrument Co.,Ltd.BWK2026-03-04
06972011718424JIAJIANWuxi Jiajian Medical Instrument Co.,Ltd.BWK2026-03-03
06972011718431JIAJIANWuxi Jiajian Medical Instrument Co.,Ltd.BWK2026-03-03
04719874910013AculifeINNO HEALTH TECHNOLOGY CO., LTD.BWK2024-03-26
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B960NSS201NSS NeuroStimNeuraxis, Inc.BWK2020-11-09
B327NSS201NSS NeurostimKEY ELECTRONICS, INC.BWK2019-03-22
B327NSS202NSS MFSKEY ELECTRONICS, INC.BWK2019-03-22
74719874910005AculifeINNO HEALTH TECHNOLOGY CO., LTD.BWK2018-11-27
00810011252509JiajianWuxi Jiajian Medical Instrument Co.,Ltd.BWK2018-11-26
08150050225006JiajianWuxi Jiajian Medical Instrument Co.,Ltd.BWK2016-10-21
10815005022400JiajianWuxi Jiajian Medical Instrument Co.,Ltd.BWK2016-10-21
04983087008403ES-130ITO CO., LTD.BWK2016-09-24
00831592004196Yingdi Multi Purpose Health DeviceUPC MEDICAL SUPPLIES, INC.BWK2016-09-23
00831592004202Yingdi Multi Purpose Health DeviceUPC MEDICAL SUPPLIES, INC.BWK2016-09-23
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