Search Filters

Search Results

Found 7 results

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.
    Ask a Question
    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.
    Ask a Question
    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.
    Ask a Question
    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.
    Ask a Question
    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).
    Ask a Question
    K Number
    K090199
    Device Name
    JIAJIAN ACUPUNCTURE NEEDLE
    Manufacturer
    WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD.
    Date Cleared
    2009-08-11

    (196 days)

    Product Code
    MQX
    Regulation Number
    880.5580
    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 Acupuncture Needle is intended to piece the skin in the practice of acupuncture therapy by qualified practitioners or acupuncture doctors as determined by the states.
    Device Description
    Jiajian brand Acupuncture Needle consists of a stainless steel wire (ASTM 304) as the needle body, with a stainless steel wire handle, a copper wire handle or polystyrol handle. The handles make the needles easier to manipulate and place. The acupuncture needle is sterilized and disposable. The diameter of the needle is 0.14~0.80mm; the length of the needle is 7~100mm; the invasive length is 2~47mm.
    Ask a Question
    K Number
    K090198
    Device Name
    JIAJIAN SELF-ADHESIVE ELECTRODE
    Manufacturer
    WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD.
    Date Cleared
    2009-06-23

    (147 days)

    Product Code
    GXY, REG
    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 apply electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS (Transcutaneous Electrical Nerve Stimulation) EMS (Electrical Muscular Stimulation)
    Device Description
    Jiajian branded Self-adhesive Electrodes, wire type, are non-sterile flexible structures, composed of materials commonly used in this application: First layer: Nonwoven fabric tape Second layer. Electrically conductive carbon cloth (ValueTrode® Carbon, K970426) Third layer: Biocompatible conductive hydrogel coupling media (ValueTrode GEL, K970426), which has passed the required skin sensitivity testing criteria as specified in ISO 10993-10 and cytotoxicity testing criteria as specifeid 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 six shapes of round, rectangle, oval, gourd, butterfly and saddle of the electrodes. For the electrical connection, Jianjian provides wire type: Lead wire assembly - at least 40mm long wire with 2.5mm diameter female socket, connected to one side of the wire. The lead wire assembly is in compliance with the requirements of FDA performance standard 21 CFR Part 898 by testing under IEC 60601-1. subclause 56.3(c).
    Ask a Question

    Page 1 of 1