FDA.reportPublic FDA data

Jiajian

Primary DI
00810011252509
Brand
Jiajian
Company
Wuxi Jiajian Medical Instrument Co.,Ltd.
Model
CMNS2-1
Device description
Needle Stimulator is combined with modern micro computer high-new technique, traditional Chinese medicine acupuncture and meridian theory,based on the traditional electronic acupuncture treatment instrument. The product is used for applying low frequency pulse to stimulate the acupoints of human body.
Published
2018-11-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K130768000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130768000JIAJIAN CMN STIMULATORWuxi Jiajian Medical Instrument Co., Ltd.2013-08-16BWK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20810011252503PackageGS120In Commercial Distribution
00810011252509PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081001125250320810011252503
00810011252509008100112525098100112525090810011252509

GMDN Terms#

Term, Definition table
TermDefinition
Migraine-therapy peripheral nerve electrical stimulatorA portable electrically-powered device designed to non-invasively stimulate a peripheral nerve(s) [including vagus nerve] in the neck, trunk or extremity to treat or prevent symptoms of migraine/headaches. It typically consists of a unit with operator controls, user display, and metal skin contact surfaces that enable application of the electrical signal intended to provide a localized oscillating electric field; it may be used in conjunction with a smartphone. The device is typically used with conductive gel and may be operated by a patient or healthcare provider in the home and healthcare facility. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529966489
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06932307410395JIAJIANCMNS6-1 PLUS2026-03-04
06932307410401JIAJIANCMNS6-32026-03-04
06932307410418JIAJIANTENS WMPS2-12026-03-04
06932307410432JIAJIANTENStem eco basic2026-03-04
06932307410449JIAJIANWQ-10D12026-03-04
06932307410456JIAJIANWQ-6F2026-03-04
06932307410425JIAJIANTENS WMPS6-12026-03-03
06972011718424JIAJIANCMNS6-12026-03-03
06972011718431JIAJIANCMNS6-22026-03-03
00810011251601JiajianTENS2019-02-19
04260505370046alegriaCare50*100mm2017-08-25
04260505370053alegriaCare50*100mm2017-08-28
04260505370084alegriaCare50*50mm2017-08-25
04260505370121alegriaCare50*502017-08-30
04260505370138alegriaCareround 32mm2017-08-30
00185098000854Infrared Heating devicePM-7502016-10-21
04260505370015alegriaCare50*50mm2017-08-25
04260505370022alegriaCare50*502017-08-30
04260505370039alegriaCare50*50mm2017-08-25
04260505370060alegriaCareRound 25mm2017-08-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00768627017145Blue Diamond 360 Needle StimulatorNORTH COAST MEDICAL, INC.BWK2026-06-01
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
14897076722812SEARCH+STIM PROBE AXUS ES-5TENS PLUS INDUSTRIAL COMPANYBWK2022-11-14
14897076720092AXUS ES-5TENS PLUS INDUSTRIAL COMPANYBWK2021-03-30
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
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
00831592004219Yingdi Multi Purpose Health DeviceUPC MEDICAL SUPPLIES, INC.BWK2016-09-23