FDA.reportPublic FDA data

Jiajian

Primary DI
06972011713504
Brand
Jiajian
Company
Wuxi Jiajian Medical Instrument Co.,Ltd.
Model
pointoselect
Device description
An electronic probe used to precisely locate an acupuncture point on a patient's body.It is used in complemently medicine therapy either independently or with a device intented to apply stilmuli to acupuncture site (e.g., an electrical stimulator). It may include visual or audio singals to indicate the acupuncture point. This is a reusable device.
Published
2019-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123958000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123958000JIAJIAN POINTOSELECT DIGITALWuxi Jiajian Medical Instrument Co., Ltd.2013-10-28GZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16972011713501PackageGS120In Commercial Distribution
06972011713504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697201171350116972011713501
06972011713504069720117135046972011713504

GMDN Terms#

Term, Definition table
TermDefinition
Acupuncture point detectorAn electronic probe used to precisely locate an acupuncture point on a patient's body. It is used in complementary medicine therapy either independently or with a device intended to apply stimuli to acupuncture sites (e.g., an electrical stimulator). It may include visual or audio signals to indicate the acupuncture point. This is a reusable device.

Regulatory Flags#

DUNS number
529966489
Device count
1
Lot or batch
true
Serial number
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

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