FDA.reportPublic FDA data

Jiajian

Primary DI
16972011713501
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
Rx
false
OTC
false
Sterile
false
Single use
false

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529966489
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00850298007072Monitoring Lead Wires, Set of 9SOMATICS, LLCGZJ2026-05-28
03770018808086actiTENSSUBLIMEDGZJ2026-05-27
03770018808093actiTENSSUBLIMEDGZJ2026-05-27
03770018808109actiTENSSUBLIMEDGZJ2026-05-27
03770018808116actiTENSSUBLIMEDGZJ2026-05-27
03770018808253actiTENS MiniSUBLIMEDGZJ2026-05-27
03770018808260actiTENS MiniSUBLIMEDGZJ2026-05-27
00714905710024Fab StimDrive Devilbiss HealthcareGZJ2026-02-06
00810140062680RENPHOJoicom CorporationGZJ2025-10-20
00810140062697RENPHOJoicom CorporationGZJ2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.GZJ2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.GZJ2025-10-03
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.GZJ2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.GZJ2025-09-11
00810113683379DualPulse CompactManamed, Inc.GZJ2025-09-11
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.GZJ2025-09-11
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.GZJ2025-08-21
08809851470091EVE Synergy; EVE TitanWEERO Co., Ltd.GZJ2025-06-24
00661168000037Reliefband® Sport - BlackRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00661168000044Reliefband® Sport - Soft GreyRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00661168000167Reliefband® 50 HoursRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00661168000181Reliefband® Premier PlusRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00815290018303Therapist’s Choice® TENS 12MT Small Carrying CaseCLINICAL HEALTH SERVICES, INC.GZJ2024-12-21
14897076723536E-Stim IIITENS PLUS INDUSTRIAL COMPANYGZJ2024-12-10
00810113683218ManaMedManamed, Inc.GZJ2024-04-30
B786SBM1AB0110actiTENSSUBLIMEDGZJ2024-04-24
20192253018360Uni-PatchCardinal Health 200, LLCGZJ2024-02-28
20192253018377Uni-PatchCardinal Health 200, LLCGZJ2024-02-28
B731P12T109TrueReliefTruerelief, LLCGZJ2024-01-08
00815290019409ePower® T1 TENS UNITCLINICAL HEALTH SERVICES, INC.GZJ2023-09-17