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510(k) Data Aggregation

    K Number
    K244030
    Device Name
    Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)
    Manufacturer
    Wuxi Jiajian Medical Instrument Co., Ltd.
    Date Cleared
    2025-03-28

    (88 days)

    Product Code
    BWK
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Wuxi Jiajian Medical Instrument Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Needle Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
    Device Description
    Needle Stimulator is an electro-acupuncture device for acupuncture therapy, powered by 6 pieces of 1.5V batteries or AC 100-240V. It is composed of a console and 6 channels of electrode cables with alligator type connectors. The console has the operating controls including function knobs or buttons. Needle Stimulator does not equip with acupuncture needles. The practitioners should select legally marketed needles.
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    K Number
    K231425
    Device Name
    Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)
    Manufacturer
    Wuxi Jiajian Medical Instrument Co., Ltd
    Date Cleared
    2024-03-27

    (315 days)

    Product Code
    NUH
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    Wuxi Jiajian Medical Instrument Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Transcutaneous Electrical Nerve Stimulator (Model:TENS WMPS2-1) can be used for the symptomatic relief of chronic intractable pain, post traumatic pain adjunctive treatment, and post-surgical pain adjunctive treatment.
    Device Description
    Transcutaneous Electrical Nerve Stimulator sends gentle electrical current to underlying nerves and muscle groups via electrodes applied onto the skin to relieve pain. The device has 16 programs (12 standard programs and 4 editable programs). It is a lithium battery-powered device comprising the electronic stimulatory module, the accessories of lead wires, the electrodes and the adapter. Two outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes are 510(k) cleared devices (K192568). Size 50*50mm.
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    K Number
    K222879
    Device Name
    Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)
    Manufacturer
    Wuxi Jiajian Medical Instrument Co., Ltd
    Date Cleared
    2023-01-24

    (124 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    Wuxi Jiajian Medical Instrument Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, the TENS WMPS6-1 is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment in the management of post-surgical and post traumatic pain.
    Device Description
    Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. The device has 18 programs (13 standard programs and 5 editable programs), powered by 6 pieces of 1.5V batteries or AC 100-240V, comprising electronic stimulatory module and accessories of lead wires, electrodes. Six outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes is 510(k) cleared device (K192568), Size: 50*50mm.
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    K Number
    K202861
    Device Name
    Needle Stimulator
    Manufacturer
    Wuxi Jiajian Medical Instrument Co., Ltd
    Date Cleared
    2021-08-27

    (333 days)

    Product Code
    BWK
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Wuxi Jiajian Medical Instrument Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Needle Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
    Device Description
    Needle Stimulator is an electro-acupuncture device for acupuncture therapy powered by 6 pieces of 1.5V batteries or AC 100-240V. It is composed of a console and 6 channels of electrode cables with alligator type connectors. The console has the operating controls including function knobs or buttons. Needle Stimulator does not equip with acupuncture needles. The practitioners should select legally marketed needles.
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    K Number
    K202893
    Device Name
    Transcutaneous Electrical Nerve Stimulator
    Manufacturer
    Wuxi Jiajian Medical Instrument Co., Ltd
    Date Cleared
    2021-06-18

    (263 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    Wuxi Jiajian Medical Instrument Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Transcutaneous Electrical Nerve Stimulator is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment of post surgical and post traumatic pain.
    Device Description
    Transcutaneous Electrical Nerve Stimulator is Transcutaneous Electrical Nerve Stimulator for pain relief. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The device has standard programs and edit programs. It is a battery-powered portable device, comprising electronic stimulatory module and accessories of lead wires, electrodes and battery. Two outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes is 510(k) cleared device (K192568), Size: 50*50mm.
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    K Number
    K192568
    Device Name
    Jiajian Self-Adhesive Electrode
    Manufacturer
    Wuxi Jiajian Medical Instrument Co., Ltd
    Date Cleared
    2021-02-03

    (504 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    Wuxi Jiajian Medical Instrument Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Self-adhesive electrode is intended to be used to transmit electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS and EMS.
    Device Description
    The Self-adhesive electrode, lead wire type and snap button type, are non-sterile flexible structures, composed of materials commonly used in this application: First layer: Non-woven fabric tape Second layer: Polyurethane (PU) electrically conductive carbon cloth (Hebei Kangshengda Electronic Technology Co., Ltd) Third layer: Biocompatible conductive hydrogel coupling media (ValueTrode Carbon, K970426), which has passed the required skin sensitivity testing criteria as specified in ISO 10993-10 and cytotoxicity testing criteria as specified in ISO ISO 10993-5. The electrodes are designed for single patient / multiple application use. It can be used for low-frequency or medium-frequency nerve or muscle stimulators, as the conduction film adhered to body skin. There are nine shapes of round, rectangle, elliptical, calabash, butterfly, saddle shape, rhombus, meniscus shape and palm shape. For the electrical connection, Jiajian provides lead wire type and snap button type: Lead wire assembly - at least 40mm long wire with 2mm/2.5mm diameter female socket. Snap button assembly - with 2.5~5mm diameter male socket. The lead wire assembly is in compliance with the requirements of FDA performance standard 21 CFR part 898 by testing under ANSI/AAMI ES60601-1, subclause 8.5.2.3.
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    K Number
    K123958
    Device Name
    JIAJIAN POINTOSELECT DIGITAL
    Manufacturer
    WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD.
    Date Cleared
    2013-10-28

    (311 days)

    Product Code
    GZJ, GZI
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Jiajian® Pointoselect Digital is intended for use in the symptomatic relief of chronic intractable pain, postoperative pain, and acute pain.
    Device Description
    Jiajian® Pointoselect Digital is a newly designed and easy to operate hand held stimulator. It is 9V battery powered device, with an LCD in the console. which can display the selected operation mode, intensity, frequency, pulse width, and battery level of the device, and so on. The device composes of a console, a hand held probe, a hand grip electrode, and lead wires. The hand probe can be used for treatment at individual sites. When using the hand probe, the patient must hold the hand grip electrode in order to electrically ground the device.
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    K Number
    K130768
    Device Name
    JIAJIAN CMN STIMULATOR
    Manufacturer
    WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD.
    Date Cleared
    2013-08-16

    (149 days)

    Product Code
    BWK
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Jiajian® CMN Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
    Device Description
    Jiajian® CMN Stimulator is an electro-acupuncture device for acupuncture therapy, powered by 6 pieces of 1.5V batteries. It is composed of a console and 6 channels of electrode cables with alligator type connectors. Only 3 channels at most could work together on single patient. The console has the operating elements of Wave choosing knob, Frequency adjust knob, Intensity adjust knobs, and Timer. Jiajian® CMN Stimulator does not equip with acupuncture needles. The practitioners should select 510(k) cleared needles (with minimum diameter of 0.30mm and insertion depth of 15mm) for use.
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    K Number
    K122812
    Device Name
    JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS
    Manufacturer
    WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD.
    Date Cleared
    2013-04-11

    (210 days)

    Product Code
    BWK
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Jiajian® Electro-acupuncture Stimulator, Model WQ-10D1 and WQ-6F are electro-acupuncture stimulator devices, which are indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
    Device Description
    Jiajian® Electro-acupuncture Stimulator, Model WQ-10D1, is a battery powered instrument with 3 channel outputs for acupuncture needle stimulation. The predicate device is ES-130, K081943. The output frequency and intensity for stimulation are adjustable. The stimulation time can be set. The 3 channels can output stimulation simultaneously. The device is powered by DC 9V battery, Type 6F22. When the battery has insufficient voltage (<8.5V), the light goes out. The user should replace battery. WQ-10D1 does not equip with acupuncture needles. The practitioners should select 510(k) cleared needles (with minimum diameter of 0.30mm and insertion depth of 15mm) for use. Jiajian® Electro-acupuncture Stimulator, Model WQ-6F, is an electro-acupuncture device, composed of a main unit and seven separate lead wires which represent 7 output channels. 4 output channels are grouped in Section A and 3 output channels are grouped in Section B. Section A and B have separate intensity and frequency adjusting knobs. The 4 channels in Section A can output waveforms simultaneously, and the 3 channels in Section B can output waveforms simultaneously but Section A and Section B can not output waveforms simultaneously. The main unit is powered by DC4.5V battery (three No 1 battery, Size "D"). When the battery has insufficient voltage (<4.1V), the light goes out. The user should replace battery. WQ-6F does not equip with acupuncture needles. The practitioners should select 510(k) cleared needles (with minimum diameter of 0.30mm and insertion depth of 15mm) for use. The predicate device of WQ-6F is ES-130, K081943.
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    K Number
    K112288
    Device Name
    JIAJIAN TENS
    Manufacturer
    WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD.
    Date Cleared
    2012-05-02

    (267 days)

    Product Code
    GZJ, DEV
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Jiajian® TENS is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment in the management of post surgical and post traumatic pain.
    Device Description
    Jiajian® TENS, is Transcutaneous Electrical Nerve Stimulator for pain relief. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. It is a battery-powered portable device, comprising electronic stimulatory module and accessories of lead wires and 9 volt type 6F22 battery. When using this device, the physician should select and use 510(k) cleared electrodes. The area of electrodes must be larger than 8cm2. The electronic stimulatory module has the operating elements of (1) Display screen, 2 Menu keys, 3 Modification keys, 4 On/Off key, 5 Battery compartment and (6) Outlet socket. The display screen can show (a) battery power, (b) selected program, (c) lasting time or left time of a program, (d) current intensity for each channel, (e) program phase and (f) locking state. The menu key "P" is for selecting standard program or user-program, and for locking; the menu key "E" is for editing program when the device is not being locked. The modification key "3A" and "3B" are for intensity level adjustment during stimulation. The outlet socket is used to connect skin electrodes by lead wires. The device has 12 selectable programs, which can be grouped into 4 output modes, i.e. Normal mode (P1, P2, P3, P4, P5, P6), Burst mode (P7, P12), Rate & width modulation (P8), and Intensity modulation (P9, P10, P11).
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