FDA.reportPublic FDA data

QIJIU

Primary DI
06973774194265
Brand
QIJIU
Company
Bozhou Rongjian Medical Appliance Co., Ltd.
Model
RJNS6-1
Device description
Needle Stimulator
Published
2026-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
K220153000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220153000Needle Stimulator (Model: RJNS6-1)Bozhou Rongjian Medical Appliance Co., Ltd.2022-03-18BWK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973774194265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973774194265069737741942656973774194265

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.

Regulatory Flags#

DUNS number
703044684
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973774194296QIJIURound Φ32mm2026-04-08
06973774194302QIJIURound Φ50mm2026-04-08
06973774194319QIJIURectangle 40x40mm2026-04-08
06973774194326QIJIURectangle 50x50mm2026-04-08
06973774194333QIJIURectangle 50x90mm2026-04-08
06973774194340QIJIURectangle 50x100mm2026-04-08
06973774194357QIJIURectangle 50x130mm2026-04-08
06973774194364QIJIURectangle 80x130mm2026-04-08
06973774194371QIJIURound Φ32mm2026-04-08
06973774194388QIJIURound Φ50mm2026-04-08
06973774194395QIJIURectangle 40x40mm2026-04-08
06973774194401QIJIURectangle 50x50mm2026-04-08
06973774194418QIJIURectangle 50x90mm2026-04-08
06973774194425QIJIURectangle 50x100mm2026-04-08
06973774194432QIJIURectangle 50x130mm2026-04-08
06973774194449QIJIURectangle 80x130mm2026-04-08
06973774194272QIJIURJTENS-12026-04-03
06973774194289QIJIURJTENS-22026-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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