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.

AI/ML Overview

The provided document describes the Wuxi Jiajian Medical Instrument Co., Ltd.'s Electro-acupuncture Stimulators (Model WQ-10D1 and WQ-6F) and its 510(k) summary for substantial equivalence to a predicate device. This submission focuses on comparing the new device's technical specifications and safety standards to those of the predicate device, not on clinical performance or specific acceptance criteria met through clinical studies with human subjects.

Therefore, many of the requested categories related to clinical study design (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set) are not applicable to this type of regulatory submission, which primarily relies on engineering performance testing and comparison to a legally marketed predicate device.

However, the document does list product specifications and safety standard compliance, which could be considered criteria for acceptance in a technical and regulatory context.

Here's the information that can be extracted from the provided text according to your request categories:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission for substantial equivalence based on technical characteristics and safety standards, the "acceptance criteria" are generally that the new device's parameters and safety performance are equivalent to or within the acceptable limits established by the predicate device and relevant standards. The "reported device performance" refers to the new device's measured specifications. The tables below synthesize this information for key parameters, highlighting where differences exist and how they are addressed in the substantial equivalence discussion.

Jiajian® Electro-acupuncture Stimulator, Model WQ-10D1 vs. Predicate Device ES-130 (K081943)

Parameter	Acceptance Criteria (Predicate Device ES-130)	Reported Device Performance (Jiajian® WQ-10D1)	Substantial Equivalence Discussion / Justification
Intended Use	Practice of acupuncture by qualified practitioners	Practice of acupuncture by qualified practitioners	Similar. Same intended use.
Power Source	DC 9V battery, Type 6F22	DC 9V battery, Type 6F22	Similar.
Compliance with Voluntary Standards	IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2	IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2	Similar. Both comply with the same safety standards.
Compliance with 21 CFR 898	Yes	Yes	Similar.
Waveform	Biphasic, Asymmetric biphasic square wave	Biphasic, Asymmetric biphasic square wave	Similar.
Net Charge (per pulse @500Ω)	0μC	0μC	Similar. Both devices have zero net charge, ensuring no DC current accumulation.
Max Output Voltage (Low Intensity @500Ω)	18V ± 15%	11V ± 15%	Difference. New device has lower max output voltage. Justified by physiological effectiveness depending primarily on delivered charge, and the new device's maximum phase charge is slightly higher while within safety limits.
Max Output Current (Low Intensity @500Ω)	36.0mA ± 15%	22mA ± 15%	Difference. New device has lower max output current. Justified by physiological effectiveness depending primarily on delivered charge, and the new device's maximum phase charge is slightly higher while within safety limits.
Pulse Duration (Positive)	100μS	480 ± 10% μS	Difference. New device has higher pulse width. Justified by physiological effectiveness depending primarily on delivered charge, and the new device's maximum phase charge is slightly higher while within safety limits. Duty cycle is similar. Does not raise new safety or effectiveness concerns.
Frequency (Hz)	1~500Hz	0~100Hz	Difference. New device has a lower frequency range. Justified by physiological effectiveness depending primarily on delivered charge, and the new device's maximum phase charge is slightly higher while within safety limits. Duty cycle is similar. Does not raise new safety or effectiveness concerns.
Maximum Phase Charge (μC)	7.2μC	17.2μC	Difference. New device has a higher maximum phase charge. Justified that this enables effectiveness and is within safety limits. Addressed as not raising new safety or effectiveness concerns.
Max Current Density (mA/cm², r.m.s.)	25.5mA/cm²	12.2mA/cm²	Difference. New device has lower current density. Justified as being within safety limits per IEC 60601-2-10 and FDA guidance.
Max Average Power Density (W/cm²)	0.24W/cm²	0.09W/cm²	Difference. New device has lower average power density. Justified as being within safety limits per IEC 60601-2-10 and FDA guidance.
Burst Mode	N/A (continuous train of impulses)	Present (various intermittent, rise-fall, sawtooth waves)	Difference. The new device has burst modes. Justified that the basic characteristics of burst mode are consistent with continuous wave, so this difference does not raise new types of safety or effectiveness questions.
CA-AM knob	Constant amplitude only	CA-AM knob (Constant Amplitude and Amplitude Modulated wave)	Difference. The new device offers amplitude modulation. Justified that physiological effectiveness can also be achieved through modulated amplitude, not just constant pulse trains, thus not raising new types of safety or effectiveness questions.
Battery Level Indicator	Check button	Auto shut off <8.5V	Difference. Different method of warning for low battery. No safety or effectiveness concerns raised.
Weight	160g	450g	Difference. Different physical characteristics, but not related to safety or effectiveness.
Dimensions	96x63x27mm	135x90x55mm	Difference. Different physical characteristics, but not related to safety or effectiveness.

Jiajian® Electro-acupuncture Stimulator, Model WQ-6F vs. Predicate Device ES-130 (K081943)

Parameter	Acceptance Criteria (Predicate Device ES-130)	Reported Device Performance (Jiajian® WQ-6F)	Substantial Equivalence Discussion / Justification
Intended Use	Practice of acupuncture by qualified practitioners	Practice of acupuncture by qualified practitioners	Similar. Same intended use.
Compliance with Voluntary Standards	IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2	IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2	Similar. Both comply with the same safety standards.
Compliance with 21 CFR 898	Yes	Yes	Similar.
Waveform	Biphasic, Asymmetric biphasic square wave	Biphasic, Asymmetric biphasic square wave	Similar.
Net Charge (per pulse @500Ω)	0μC	0μC	Similar. Both devices have zero net charge, ensuring no DC current accumulation.
Power Source	DC 9V battery, Type 6F22	DC 4.5V (Three No 1 batteries, Size "D")	Difference. Different power source. Addressed, but no safety concerns raised.
Max Output Voltage (Low Intensity @500Ω)	18V ± 15%	8V ± 15%	Difference. New device has lower max output voltage. Justified by physiological effectiveness depending primarily on delivered charge, and the new device's maximum phase charge is slightly higher while within safety limits.
Max Output Current (Low Intensity @500Ω)	36.0mA ± 15%	16mA ± 15%	Difference. New device has lower max output current. Justified by physiological effectiveness depending primarily on delivered charge, and the new device's maximum phase charge is slightly higher while within safety limits.
Pulse Duration (Positive)	100μS	Section A: 700µs±10% (x1), 500µs±10% (x10)	Difference. New device has different pulse widths. Justified that both devices use "normal stimulation pulse width and frequency." Physiological effectiveness depends on delivered charge, and new device's max phase charge is slightly higher and within safety limits, so no new safety/effectiveness concerns.
Frequency (Hz)	1~500Hz	Multiplier x 1: 0~~20Hz; Multiplier x 10: 0~~200Hz	Difference. New device has different frequency ranges. Justified that both devices use "normal stimulation pulse width and frequency." Physiological effectiveness depends on delivered charge, and new device's max phase charge is slightly higher and within safety limits, so no new safety/effectiveness concerns.
Maximum Phase Charge (μC)	7.2μC	12.4μC	Difference. New device has a higher maximum phase charge. Justified that this enables effectiveness and is within safety limits. Addressed as not raising new safety or effectiveness concerns.
Max Current Density (mA/cm², r.m.s.)	25.5mA/cm²	17.6mA/cm²	Difference. New device has lower current density. Justified as being within safety limits per IEC 60601-2-10 and FDA guidance, even with 7 channels (considering only 4 active at once for patient safety).
Max Average Power Density (W/cm²)	0.24W/cm²	0.12W/cm²	Difference. New device has lower average power density. Justified as being within safety limits per IEC 60601-2-10 and FDA guidance.
Burst Mode	N/A (continuous train of impulses)	Present (various intermittent, rise-fall, sawtooth waves)	Difference. The new device has burst modes. Justified that the basic characteristics of burst mode are consistent with continuous wave, so this difference does not raise new types of safety or effectiveness questions.
CA-AM knob	Constant amplitude only	CA-AM knob (Constant Amplitude and Amplitude Modulated wave)	Difference. The new device offers amplitude modulation. Justified that physiological effectiveness can also be achieved through modulated amplitude, not just constant pulse trains, thus not raising new types of safety or effectiveness questions.
Battery Level Indicator	Check button	Auto shut off <4.1V	Difference. Different method of warning for low battery. No safety or effectiveness concerns raised.
Number of output channels	3	7 (4 in Section A, 3 in Section B)	Difference. The new device has more channels, but only 4 can be active simultaneously for a single patient in Section A. This difference is accounted for in the safety analysis of maximum RMS current and power density, which are still within limits.
Weight	160g	1.03kg	Difference. Different physical characteristics, but not related to safety or effectiveness.
Dimensions	96x63x27mm	235x170x75mm	Difference. Different physical characteristics, but not related to safety or effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission is based on engineering and performance testing against safety standards, not a clinical trial with a test set of patients or medical images. The device was manufactured in China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as there was no test set requiring expert ground truth in the context of a clinical study. The "ground truth" for this submission are the established safety standards (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2) and the technical specifications of the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as there was no clinical test set requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not done. This device is an electro-acupuncture stimulator, not an AI-assisted diagnostic or treatment planning system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This is a physical medical device, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this submission consists of:

Compliance with international safety standards: IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2.
The technical specifications and established safety profile of the predicate device, ES-130 (K081943).
Regulatory guidance from the FDA regarding safety limits.

8. The sample size for the training set

This information is not applicable as there was no training set in the context of machine learning or clinical trials.

9. How the ground truth for the training set was established

This information is not applicable as there was no training set.

Summary

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Wuxi Jiajian Medical Instrument Co., Ltd

Qinghong Rd., Ehu Town, Xishan District, Wuxi, Jiangsu, China 214116

Section 5

510(k) Summary

[As required by 21 CFR 807.92]

1. Submission Information
510(k) Number:	K122812
Date:	Feb 27th, 2013
Type of 510(k) Submission:	Traditional
Basis for 510(k) Submission:	New device
Submitter/Manufacturer:	Wuxi Jiajian Medical Instrument Co., LtdQinghong Rd., Ehu Town, Xishan District, Wuxi, China 214116
Contactor:	Doris Dong[Consultant, from Shanghai CV Technology Co., Ltd.]Add.: Room 1706 Yuesha, No. 128 Songle Rd., Songjiang, Shanghai, China 201600E-mail: doris_d@126.comTel: 86 21-31261348Fax: 86 21-37824346

2. Device Description

Proprietary Name:	Jiajian® Electro-acupuncture Stimulators(Model: WQ-10D1 and WQ-6F)
Common Name:	Electro-acupuncture Device
Classification Name:	Stimulator, Electro-acupuncture
Regulation Number:	Unclassified
Review Panel:	Neurology
Product Code:	BWK
Device Class:	Unclassified, 510(k)
Device Description:	Jiajian® Electro-acupuncture Stimulator, Model WQ-10D1, is a batterypowered instrument with 3 channel outputs for acupuncture needlestimulation. The predicate device is ES-130, K081943.The output frequency and intensity for stimulation are adjustable. Thestimulation time can be set. The 3 channels can output stimulationsimultaneously.The device is powered by DC 9V battery, Type 6F22. When the batteryhas insufficient voltage (<8.5V), the light goes out. The user should replacebattery.WQ-10D1 does not equip with acupuncture needles. The practitionersshould select 510(k) cleared needles (with minimum diameter of 0.30mmand insertion depth of 15mm) for use.Jiajian® Electro-acupuncture Stimulator, Model WQ-6F, is anelectro-acupuncture device, composed of a main unit and seven separatelead wires which represent 7 output channels. 4 output channels are groupedin Section A and 3 output channels are grouped in Section B. Section A andB have separate intensity and frequency adjusting knobs.The 4 channels in Section A can output waveforms simultaneously, andthe 3 channels in Section B can output waveforms simultaneously but

APR 1 1 2013

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Wuxi Jiajian Medical Instrument Co., Ltd Qinghong Rd., Ehu Town, Xishan District, Wuxi, Jiangsu, China 214116

	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.
Indications for 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.

3. Predicate Devices

3.1 For Model WQ-10D1:

Detailed comparison data is included in "Section 9 - Substantial Equivalence Discussion" of this 510(k) submission. Following are summarized comparison tables with predicate devices.

Parameters		New Device	Predicate Device
1.	510(k) Number:	K122812	K081943
2.	Marketing clearance date:		Nov 24th, 2008
3.	Device Name	Jiajian* Electro-acupuncture Stimulators,Model WQ-10D1	ES-130
4.	Manufacturer	Wuxi Jiajian Medical Instrument Co., Ltd	ITO Co., Ltd.
5.	Accessories forelectro-acupuncturestimulation mode	Lead wire with alligator type connector (3sets, in three different colors)	Lead wire with alligator type connector(3 sets, in three different colors)
6.	Intended use	Jiajian* Electro-acupuncture Stimulator isindicated for use in the practice ofacupuncture by qualified practitioners ofacupuncture as determined by the states.	ES-130 is indicated for use in thepractice of acupuncture by qualifiedpractitioners of acupuncture asdetermined by the states.
7.	Power Source(s)	DC 9V battery, Type 6F22	DC 9V battery, Type 6F22
8.	Compliance with VoluntaryStandards?	IEC 60601-1, IEC 60601-2-10, IEC60601-1-2	IEC 60601-1, IEC 60601-2-10, IEC60601-1-2
9.	Compliance with 21 CFR898?	Yes	Yes
10.	Weight (grams)	450g	160g
11.	Dimensions (mm) [W x H xD]	135x90x55mm	96mm(H)x63mm(W)x27mm(D)
12.	Housing Materials &Construction	ABS; Injection molded	ABS; Injection molded
13.	Waveform	Biphasic	Biphasic
14.	Shape	Asymmetric biphasic square wave	Asymmetric biphasic square wave
15.	Maximum Output Voltage(volts)	Low Intensity:$11V \pm 15% @500\Omega$	Low Intensity:$18V\pm 15% @500\Omega$

3.1.1 New device VS. Predicate device ES-130:

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KR2812

Wuxi Jiajian Medical Instrument Co., Ltd
Qinghong Rd., Ehu Town, Xishan District, Wuxi, Jiangsu, China 214116

JIAVIAN®

维固医疗

16.		Maximum Output Current(mA)	Low Intensity:	Low Intensity:
			$22mA ±15% @500Ω$	$36.0mA ±15% @500Ω$
17.	Pulse	Positive	$480±10% μS$	$100μS$
	Duration	Negative	4 x (+Phase)	Not Stated in the manual
	(μsec)
18.		Frequency (Hz) [or Rate(pps)]	0~100Hz	1~500Hz
19.		Net Charge(microcoulombs (μC) perpulse)	$0μC@500Ω$ , + and – pulses cancel	$0μC@500Ω$
20.		Maximum Phase Charge,(μC)	17.2μC	7.2μC
21.		Maximum Current Density,(mA/cm², r.m.s.)	12.2mA/cm²	25.5mA/cm²
22.		Maximum Average PowerDensity, (W/cm²)	0.09W/cm²	0.24W/cm²
23.	Burst	(a) Pulses perburst	2-250 (Intermittent wave)	N/A
	Mode		2~320 (Rise-fall wave, Rise dense-falldisperse wave)
	(i.e.,pulsetrains)		2~220 (Saw tooth wave)
		(b) Bursts persecond	0.2 (Intermittent wave, Rise-fall wave, Risedense-fall disperse wave, Saw tooth wave)	N/A
		(c) Burst duration(seconds)	2.5 (Intermittent wave)	N/A
			3.2 (Rise-fall wave, Rise dense-fall dispersewave)
			2.2 (Saw tooth wave)
		(d) Duty Cycle:Line (b) x Line (c)	0.5 (Intermittent wave)	N/A
			0.64 (Rise-fall wave, Rise dense-fall dispersewave)
			0.44 (Saw tooth wave)

3.1.2 Substantial Equivalence Discussion

3.1.2 Substantial Equivalence Discussion
Similarities between New deviceand Predicate Device:	Intended use, DC power source, biphasic square waveform, zero net charge, adjustablefrequencies and intensity, number of output channels, standards
Differences between New deviceand Predicate Device:	Weight, dimensions; Output pulse width, frequency range, burst mode;The predicate device has a battery level check button, while the new device auto shut whenthe input power is less than 8.5V;The new device has CA-AM knob, while the predicate device has only constant amplitude
Conclusion:	The new device and the predicate device have same intended use, biphasic squarewaveform, zero net charge, number of output channels, adjustable frequency and intensity,complied standards.The differences between the two devices are analyzed as following:(1) Burst mode: The new device has burst mode which is composed of a continuous train ofimpulses with a small pause in between while the predicate device has continuous train ofimpulses. But the basic characteristics of the burst mode of the proposed device are

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Wuxi Jiajian Medical Instrument Co., LtdQinghong Rd., Ehu Town, Xishan District, Wuxi, Jiangsu, China 214116	JIAVIAN®佳健医疗
consistent with the continuous wave, so this difference does not raise new types of questionsof safety or effectiveness.
② CA-AM knob: The new device uses the CA knob to output constant pulse trains, assame with the predicate device. The new device also uses AM knob to output amplitudemodulated wave. This difference does not raise new types of questions of safety oreffectiveness, because the physiological effectiveness of stimulation doesn't only depend onthe use of constant pulse trains as those generated by the predicate device, but also can beachieved through modulated amplitude.
③ Maximum output voltage, maximum output current, output pulse width, frequencyrange:
The new device has a lower maximum output voltage and current than Predicate device.The output pulse width of new device is higher than Predicate device while the frequencyrange is lower than the Predicate device. The duty cycle (pulse width*frequency) of bothdevice is similar.
Because the physiological effectiveness of stimulation is primarily dependent on deliveredcharge, and the maximum phase charge per pulse of the new device is a little higher thanthe Predicate device, so it can achieve the effectiveness. And the maximum output Charge iswithin the safety limit.
Therefore this difference does not raise new types of questions of safety or effectiveness.
④ Maximum power density value, total maximum RMS current passed through the bodyare different, but the values are within the safety limit according to IEC 60601-2-10 and thesafety limit regulated by FDA guidance. So the differences would not raise new safety

3.2 For Model WQ-6F:

3.2.1 New device VS. Predicate device:

concerns.

ES-130 (K081943).

	Parameters	New Device	Predicate Device
1.	510(k) Number:	K122812	K081943
2.	Marketing clearance date:	--	Nov 24th, 2008
3.	Device Name	Jiajian® Electro-acupuncture Stimulators,Model WQ-6F	ES-130
4.	Manufacturer	Wuxi Jiajian Medical Instrument Co., Ltd	ITO Co., Ltd.
5.	Accessories	Lead wire with alligator type connector (7sets, in seven different colors)	Lead wire with alligator type connector (3sets, in three different colors)
6.	Intended use	Jiajian® Electro-acupuncture Stimulator isindicated for use in the practice ofacupuncture by qualified practitioners ofacupuncture as determined by the states.	ES-130 is indicated for use in the practiceof acupuncture by qualified practitioners ofacupuncture as determined by the states.
7.	Power Source(s)	DC 4.5V (Three No 1 batteries, Size "D")	DC 9V battery, Type 6F22
8.	Compliance with VoluntaryStandards?	IEC 60601-1, IEC 60601-2-10, IEC60601-1-2	IEC 60601-1, IEC 60601-2-10, IEC60601-1-2
9.	Compliance with 21 CFR898?	Yes	Yes

To sum up, the new device WQ-10D1 is substantially equivalent to Predicate device of

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2812

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K122812

Wuxi Jiajian Medical Instrument Co., Ltd

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Qinghong Rd., Ehu Town, Xishan District, Wuxi, Jiangsu, China 214116

JIAVIAN®

布联网历

10.	Weight (grams)		1.03kg		160g
11.	Dimensions (mm) [W x H xD]		235x170x75mm		96mm(H)x63mm(W)x27mm(D)
12.	Housing Materials &Construction		ABS; Injection molded		ABS; Injection molded
13.	Waveform		Biphasic		Biphasic
14.	Shape		Asymmetric biphasic square wave		Asymmetric biphasic square wave
15.	Maximum Output Voltage(volts)		Low Intensity:8V ±15% @500Ω10V ±15% @2kΩ13V ±15% @10kΩ		Low Intensity:18V±15% @500ΩNot Sated in the manualNot Sated in the manual
16.	Maximum Output Current(mA)		Low Intensity:16mA ±15% @500Ω5mA ±15% @2kΩ1.3mA ±15% @10kΩ		Low Intensity:36.0mA ±15% @500ΩNot Sated in the manualNot Sated in the manual
17.	PulseDuration(µsec)	Positive	Section A:Multiplier x 1:700µs±10%Multiplier x 10:500µs±10%	Section B	100µs
		Negative	Section A:4 x (+Phase)	Section B4 x (+Phase)	Not Sated in the manual
18.	Frequency (Hz) [or Rate(pps)]		Multiplier x 1: 0~~20HzMultiplier x 10: 0~~200Hz		1~500Hz
19.	Net Charge(microcoulombs (µC) perpulse)		0µC@500Ω, + and - pulses cancel		0µC@500Ω
20.	Maximum Phase Charge,(μC)		12.4µC		7.2µC
21.	Maximum Current Density,(mA/cm², r.m.s.)		17.6mA /cm²		25.5mA/cm²
22.	Maximum Average PowerDensity, (W/cm²)		0.12W/cm²		0.24W/cm²
23	BurstMode(i.e.,pulsetrains)	(a) Pulses perburst	2~~340 (Intermittent wave, N-Saw toothwave)2~~400 (Rise-fall wave)2-80 (I-Saw tooth wave)2~380 (Rise dense-fall disperse wave, Risedisperse-fall dense wave)	N/A
		(b) Bursts persecond	0.3 (Intermittent wave, N-Saw tooth wave,Rise-fall wave, I-Saw tooth wave, Risedense-fall disperse wave, Rise disperse-falldense wave)	N/A
		(c) Burst duration(seconds)	1.7 (Intermittent wave, N-Saw tooth wave)2.0 (Rise-fall wave)	N/A

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K12812

Wuxi Jiajian Medical Instrument Co., Ltd

Qinghong Rd., Ehu Town, Xishan District, Wuxi, Jiangsu, China 214116

રેસ33248œ02	1
3AW41

	0.4 (I-Saw tooth wave)
	1.9 (Rise dense-fall disperse wave, Risedisperse-fall dense wave)
(d) Duty Cycle:Line (b) x Line (c)	0.51(Intermittent wave, N-Saw tooth wave)	N/A
	0.6 (Rise-fall wave)
	0.12 (I-Saw tooth wave)
	0.57 (Rise dense-fall disperse wave, Risedisperse-fall dense wave)

3.2.2 Substantial Equivalence Discussion

Similarities between Newdevice and PredicateDevice:	Intended use, biphasic square waveform, zero net charge, adjustable frequencies and intensity,standards
Differences between Newdevice and PredicateDevice:	Weight, dimensions, input DC power; output pulse width, frequency range, burst mode, numberof output channels;The predicate device has a battery level check button, while the new device auto shut when theinput power is less than 4.1V;The new device has CA-AM knob, while the predicate device has only constant amplitude.
Conclusion:	The new device WQ-6F has same intended use, biphasic square waveform, Net charge, compliedstandards, adjustable frequency and intensity, with the predicate device of ES-130.The differences between the two devices are analyzed as following:(1) Burst mode: The new device has burst mode which is composed of a continuous train ofimpulses with a small pause in between while the predicate device has continuous train ofimpulses. But the basic characteristics of the burst mode of the proposed device are consistentwith the continuous wave, so this difference does not raise new types of questions of safety oreffectiveness.(2) CA-AM knob: The new device uses the CA knob to output constant pulse trains, as same withthe predicate device. The new device also uses AM knob to output amplitude modulated wave.This difference does not raise new types of questions of safety or effectiveness, because thephysiological effectiveness of stimulation doesn't only depend on the use of constant pulse trainsas those generated by the predicate device, but also can be achieved through modulated amplitude.(3) Maximum output voltage, maximum output current, output pulse width, frequency range:The new device has a lower maximum output voltage and current than Predicate device. Theoutput pulse width and frequency of new device have some difference with Predicate device. Butboth devices use normal stimulation pulse width and frequency.Because the physiological effectiveness of stimulation is primarily dependent on delivered charge,and the maximum phase charge per pulse of the new device is a little higher than the Predicatedevice, so it can achieve the effectiveness. And the maximum output Charge is within the safetylimit.Therefore this difference does not raise new types of questions of safety or effectiveness.(4) Maximum power density value, total maximum RMS current passed through the body:The proposed device WQ-6F has 7 channels of output, however, the 4 channels in Section A andthe 3 channels in Section B can not work simultaneously. The maximum output to 1 patient is 4channels in total from Section A. The maximum RMS current passed through patient calculated iswithin the safety limit according to IEC 60601-2-10. The maximum power density value is also

Similarities between Newdevice and PredicateDevice:

Intended use, biphasic square waveform, zero net charge, adjustable frequencies and intensity,standards

Differences between Newdevice and PredicateDevice:

Weight, dimensions, input DC power; output pulse width, frequency range, burst mode, numberof output channels;The predicate device has a battery level check button, while the new device auto shut when theinput power is less than 4.1V;The new device has CA-AM knob, while the predicate device has only constant amplitude.

Conclusion:

The new device WQ-6F has same intended use, biphasic square waveform, Net charge, compliedstandards, adjustable frequency and intensity, with the predicate device of ES-130.The differences between the two devices are analyzed as following:(1) Burst mode: The new device has burst mode which is composed of a continuous train ofimpulses with a small pause in between while the predicate device has continuous train ofimpulses. But the basic characteristics of the burst mode of the proposed device are consistentwith the continuous wave, so this difference does not raise new types of questions of safety oreffectiveness.(2) CA-AM knob: The new device uses the CA knob to output constant pulse trains, as same withthe predicate device. The new device also uses AM knob to output amplitude modulated wave.This difference does not raise new types of questions of safety or effectiveness, because thephysiological effectiveness of stimulation doesn't only depend on the use of constant pulse trainsas those generated by the predicate device, but also can be achieved through modulated amplitude.(3) Maximum output voltage, maximum output current, output pulse width, frequency range:The new device has a lower maximum output voltage and current than Predicate device. Theoutput pulse width and frequency of new device have some difference with Predicate device. Butboth devices use normal stimulation pulse width and frequency.Because the physiological effectiveness of stimulation is primarily dependent on delivered charge,and the maximum phase charge per pulse of the new device is a little higher than the Predicatedevice, so it can achieve the effectiveness. And the maximum output Charge is within the safetylimit.Therefore this difference does not raise new types of questions of safety or effectiveness.(4) Maximum power density value, total maximum RMS current passed through the body:The proposed device WQ-6F has 7 channels of output, however, the 4 channels in Section A andthe 3 channels in Section B can not work simultaneously. The maximum output to 1 patient is 4channels in total from Section A. The maximum RMS current passed through patient calculated iswithin the safety limit according to IEC 60601-2-10. The maximum power density value is also

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K R2 812

Wuxi Jiajian Medical Instrument Co., Ltd

Qinghong Rd., Ehu Town, Xishan District, Wuxi, Jiangsu, China 214116

within the safety limit regulated by FDA guidance.

To sum up, the new device WQ-6F is substantially equivalent to ES-130, K081943.

4. Safety and Effectiveness of the device

Jiajian® Electro-acupuncture Stimulators were tested and found to meet the safety standards of:

IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995;
IEC 60601-2-10 1987/Amendment 1 2001, Medical electrical equipment - Part 2-10: Particular

requirements for the safety of nerve and muscle stimulators; and

IEC 60601-1-2, (Second Edition, 2001), Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests

The output lead wires with connectors used for WQ-10D1 and WQ-6F were tested and found to comply with the clause 56.3(c) of the following standard:

IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.

The devices were also tested basis on reduced battery capacity, and were found that the stimulus parameters were not significantly affected (less than ±10%).

The manufacturer performed risk analysis on Needle stimulations WQ-10D1 and WQ-6F according to ISO 14971.

The conclusion drawn from the testing is that the device is substantially equivalent to the predicate devices.

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Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

April 11,2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Wuxi Jiajian Medical Instrument Co., Ltd. % Ms. Doris Dong Shanghai CV Technology Co., Ltd. Room 1706, No. 128 Songle Rd Songjiang Area Shanghai, China 201600

Re: K122812

Trade/Device Name: Jiajian Electro-acupuncture Simulators Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: BWK Dated: March 5, 2013 Received: March 11, 2013 ·

Dear Ms. Dong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28. 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Ms. Doris Dong

comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K122812

Device Name: Jiajian® Electro-acupuncture Stimulators (Model: WQ-10D1 and WQ-6F)

Indications For Use:

Jiajian® Electro-acupuncture Stimulator, Model 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.

Prescription Use J (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number K122812

Page 1 of 1

Regulation Number and Section

N/A