FDA.reportPublic FDA data

JIAJIAN

Primary DI
06932307410395
Brand
JIAJIAN
Company
Wuxi Jiajian Medical Instrument Co.,Ltd.
Model
CMNS6-1 PLUS
Device description
Needle Stimulator
Published
2026-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe

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
K244030000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K244030000Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)Wuxi Jiajian Medical Instrument Co., Ltd.2025-03-28BWK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06932307410395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06932307410395069323074103956932307410395

GMDN Terms#

Term, Definition table
TermDefinition
Acupuncture electrical stimulation systemAn electrically-powered unit designed to be used specifically to apply electrical stimuli to acupuncture sites (electroacupuncture). It is an external low-intensity, low frequency pulse (usually 1 to 100 pulses per second), multimode generator intended to connect to acupuncture electrodes. The electrodes may be placed either on the skin, or through acupuncture needles that penetrate the skin at the acupuncture points. Some may use a probe to detect the acupuncture sites using visual or audio signals.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529966489
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04260505370077alegriaCare50*502017-08-30

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
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
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
00831592004219Yingdi Multi Purpose Health DeviceUPC MEDICAL SUPPLIES, INC.BWK2016-09-23