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510(k) Data Aggregation
K Number
K244030Device 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/AWhy 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
K123958Device Name
JIAJIAN POINTOSELECT DIGITAL
Manufacturer
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD.
Date Cleared
2013-10-28
(311 days)
Product Code
GZJ, GZI
Regulation Number
882.5890Why 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
K130768Device Name
JIAJIAN CMN STIMULATOR
Manufacturer
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD.
Date Cleared
2013-08-16
(149 days)
Product Code
BWK
Regulation Number
N/AWhy 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
K122812Device 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/AWhy 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
K112288Device Name
JIAJIAN TENS
Manufacturer
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD.
Date Cleared
2012-05-02
(267 days)
Product Code
GZJ, DEV
Regulation Number
882.5890Why 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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K Number
K090199Device Name
JIAJIAN ACUPUNCTURE NEEDLE
Manufacturer
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD.
Date Cleared
2009-08-11
(196 days)
Product Code
MQX
Regulation Number
880.5580Why 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.
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K Number
K090198Device 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
882.1320Why 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).
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