JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS

K122812 · Wuxi Jiajian Medical Instrument Co., Ltd. · BWK · Apr 11, 2013 · NE

Device Facts

• Record ID: K122812
• Device Name: JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS
• Applicant: Wuxi Jiajian Medical Instrument Co., Ltd.
• Product Code: BWK · NE
• Decision Date: Apr 11, 2013
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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.

Device Story

Jiajian® Electro-acupuncture Stimulators (Models WQ-10D1 and WQ-6F) are battery-powered devices used by qualified acupuncture practitioners to provide electrical stimulation via acupuncture needles. The device transforms DC battery power into adjustable biphasic square wave electrical outputs. WQ-10D1 features 3 output channels; WQ-6F features 7 output channels (grouped into sections A and B). Practitioners connect lead wires with alligator clips to needles inserted into the patient. The device allows adjustment of frequency, intensity, and stimulation time. Output modes include constant amplitude and amplitude-modulated (AM) waves. The device provides therapeutic stimulation to the patient; clinical decision-making is guided by the practitioner's assessment. Safety features include automatic shut-off when battery voltage drops below specified thresholds (8.5V for WQ-10D1; 4.1V for WQ-6F).

Clinical Evidence

Bench testing only. The device was tested for compliance with IEC 60601-1 (General Safety), IEC 60601-2-10 (Nerve and Muscle Stimulators), and IEC 60601-1-2 (Electromagnetic Compatibility). Testing confirmed that stimulus parameters remain stable (within ±10%) under reduced battery capacity conditions. Risk analysis was performed per ISO 14971.

Technological Characteristics

Battery-powered (DC 9V for WQ-10D1; DC 4.5V for WQ-6F). Housing: ABS plastic (injection molded). Output: Biphasic square wave, zero net charge. Connectivity: Wired (lead wires with alligator connectors). Standards: IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2. Dimensions: 135x90x55mm (WQ-10D1); 235x170x75mm (WQ-6F).

Indications for Use

Indicated for use in the practice of acupuncture by qualified practitioners as determined by state regulations.

Predicate Devices

• ES-130 (K081943)

Submission Summary (Full Text)

{0}------------------------------------------------

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., Ltd<br>Qinghong Rd., Ehu Town, Xishan District, Wuxi, China 214116 |
| Contactor: | Doris Dong<br>[Consultant, from Shanghai CV Technology Co., Ltd.]<br>Add.: Room 1706 Yuesha, No. 128 Songle Rd., Songjiang, Shanghai, China 201600<br>E-mail: [e-mail]<br>Tel: [phone]<br>Fax: [phone] |

### 2. Device Description

.

| Proprietary Name: | Jiajian® Electro-acupuncture Stimulators<br>(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 battery<br>powered instrument with 3 channel outputs for acupuncture needle<br>stimulation. The predicate device is ES-130, K081943.<br>The output frequency and intensity for stimulation are adjustable. The<br>stimulation time can be set. The 3 channels can output stimulation<br>simultaneously.<br>The device is powered by DC 9V battery, Type 6F22. When the battery<br>has insufficient voltage (<8.5V), the light goes out. The user should replace<br>battery.<br>WQ-10D1 does not equip with acupuncture needles. The practitioners<br>should select 510(k) cleared needles (with minimum diameter of 0.30mm<br>and insertion depth of 15mm) for use.<br>Jiajian® Electro-acupuncture Stimulator, Model WQ-6F, is an<br>electro-acupuncture device, composed of a main unit and seven separate<br>lead wires which represent 7 output channels. 4 output channels are grouped<br>in Section A and 3 output channels are grouped in Section B. Section A and<br>B have separate intensity and frequency adjusting knobs.<br>The 4 channels in Section A can output waveforms simultaneously, and<br>the 3 channels in Section B can output waveforms simultaneously but |

APR 1 1 2013

ું તેમ

.

{1}------------------------------------------------

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,<br>Model WQ-10D1 | ES-130 |
| 4. | Manufacturer | Wuxi Jiajian Medical Instrument Co., Ltd | ITO Co., Ltd. |
| 5. | Accessories for<br>electro-acupuncture<br>stimulation mode | Lead wire with alligator type connector (3<br>sets, in three different colors) | Lead wire with alligator type connector<br>(3 sets, in three different colors) |
| 6. | Intended use | Jiajian* Electro-acupuncture Stimulator is<br>indicated for use in the practice of<br>acupuncture by qualified practitioners of<br>acupuncture as determined by the states. | ES-130 is indicated for use in the<br>practice of acupuncture by qualified<br>practitioners of acupuncture as<br>determined by the states. |
| 7. | Power Source(s) | DC 9V battery, Type 6F22 | DC 9V battery, Type 6F22 |
| 8. | Compliance with Voluntary<br>Standards? | IEC 60601-1, IEC 60601-2-10, IEC<br>60601-1-2 | IEC 60601-1, IEC 60601-2-10, IEC<br>60601-1-2 |
| 9. | Compliance with 21 CFR<br>898? | Yes | Yes |
| 10. | Weight (grams) | 450g | 160g |
| 11. | Dimensions (mm) [W x H x<br>D] | 135x90x55mm | 96mm(H)x63mm(W)x27mm(D) |
| 12. | Housing Materials &<br>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<br>(volts) | Low Intensity:<br>$11V \pm 15\% @500\Omega$ | Low Intensity:<br>$18V\pm 15\% @500\Omega$ |

### 3.1.1 New device VS. Predicate device ES-130:

{2}------------------------------------------------

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<br>(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<br>(pps)] | 0~100Hz | 1~500Hz |
| 19. | | Net Charge<br>(microcoulombs (μC) per<br>pulse) | $0μC@500Ω$ , + and – pulses cancel | $0μC@500Ω$ |
| 20. | | Maximum Phase Charge,<br>(μC) | 17.2μC | 7.2μC |
| 21. | | Maximum Current Density,<br>(mA/cm², r.m.s.) | 12.2mA/cm² | 25.5mA/cm² |
| 22. | | Maximum Average Power<br>Density, (W/cm²) | 0.09W/cm² | 0.24W/cm² |
| 23. | Burst | (a) Pulses per<br>burst | 2-250 (Intermittent wave) | N/A |
| | Mode | | 2~320 (Rise-fall wave, Rise dense-fall<br>disperse wave) | |
| | (i.e.,<br>pulse<br>trains) | | 2~220 (Saw tooth wave) | |
| | | (b) Bursts per<br>second | 0.2 (Intermittent wave, Rise-fall wave, Rise<br>dense-fall disperse wave, Saw tooth wave) | N/A |
| | | (c) Burst duration<br>(seconds) | 2.5 (Intermittent wave) | N/A |
| | | | 3.2 (Rise-fall wave, Rise dense-fall disperse<br>wave) | |
| | | | 2.2 (Saw tooth wave) | |
| | | (d) Duty Cycle:<br>Line (b) x Line (c) | 0.5 (Intermittent wave) | N/A |
| | | | 0.64 (Rise-fall wave, Rise dense-fall disperse<br>wave) | |
| | | | 0.44 (Saw tooth wave) | |

# 3.1.2 Substantial Equivalence Discussion

| 3.1.2 Substantial Equivalence Discussion | |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities between New device<br>and Predicate Device: | Intended use, DC power source, biphasic square waveform, zero net charge, adjustable<br>frequencies and intensity, number of output channels, standards |
| Differences between New device<br>and Predicate Device: | Weight, dimensions; Output pulse width, frequency range, burst mode;<br>The predicate device has a battery level check button, while the new device auto shut when<br>the input power is less than 8.5V;<br>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 square<br>waveform, zero net charge, number of output channels, adjustable frequency and intensity,<br>complied standards.<br>The differences between the two devices are analyzed as following:<br>(1) Burst mode: The new device has burst mode which is composed of a continuous train of<br>impulses with a small pause in between while the predicate device has continuous train of<br>impulses. But the basic characteristics of the burst mode of the proposed device are |

{3}------------------------------------------------

| Wuxi Jiajian Medical Instrument Co., Ltd<br>Qinghong Rd., Ehu Town, Xishan District, Wuxi, Jiangsu, China 214116 | JIAVIAN®<br>佳健医疗 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| consistent with the continuous wave, so this difference does not raise new types of questions<br>of safety or effectiveness. | |
| ② CA-AM knob: The new device uses the CA knob to output constant pulse trains, as<br>same with the predicate device. The new device also uses AM knob to output amplitude<br>modulated wave. This difference does not raise new types of questions of safety or<br>effectiveness, because the physiological effectiveness of stimulation doesn't only depend on<br>the use of constant pulse trains as those generated by the predicate device, but also can be<br>achieved through modulated amplitude. | |
| ③ Maximum output voltage, maximum output current, output pulse width, frequency<br>range: | |
| The new device has a lower maximum output voltage and current than Predicate device.<br>The output pulse width of new device is higher than Predicate device while the frequency<br>range is lower than the Predicate device. The duty cycle (pulse width*frequency) of both<br>device is similar. | |
| Because the physiological effectiveness of stimulation is primarily dependent on delivered<br>charge, and the maximum phase charge per pulse of the new device is a little higher than<br>the Predicate device, so it can achieve the effectiveness. And the maximum output Charge is<br>within 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 body<br>are different, but the values are within the safety limit according to IEC 60601-2-10 and the<br>safety 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,<br>Model WQ-6F | ES-130 |
| 4. | Manufacturer | Wuxi Jiajian Medical Instrument Co., Ltd | ITO Co., Ltd. |
| 5. | Accessories | Lead wire with alligator type connector (7<br>sets, in seven different colors) | Lead wire with alligator type connector (3<br>sets, in three different colors) |
| 6. | Intended use | Jiajian® Electro-acupuncture Stimulator is<br>indicated for use in the practice of<br>acupuncture by qualified practitioners of<br>acupuncture as determined by the states. | ES-130 is indicated for use in the practice<br>of acupuncture by qualified practitioners of<br>acupuncture 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 Voluntary<br>Standards? | IEC 60601-1, IEC 60601-2-10, IEC<br>60601-1-2 | IEC 60601-1, IEC 60601-2-10, IEC<br>60601-1-2 |
| 9. | Compliance with 21 CFR<br>898? | Yes | Yes |

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

.

4-7

.

2812

{4}------------------------------------------------

K122812

Wuxi Jiajian Medical Instrument Co., Ltd

·

·

-

: ,

:

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 x<br>D] | | 235x170x75mm | | 96mm(H)x63mm(W)x27mm(D) |
| 12. | Housing Materials &<br>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<br>(volts) | | Low Intensity:<br>8V ±15% @500Ω<br>10V ±15% @2kΩ<br>13V ±15% @10kΩ | | Low Intensity:<br>18V±15% @500Ω<br>Not Sated in the manual<br>Not Sated in the manual |
| 16. | Maximum Output Current<br>(mA) | | Low Intensity:<br>16mA ±15% @500Ω<br>5mA ±15% @2kΩ<br>1.3mA ±15% @10kΩ | | Low Intensity:<br>36.0mA ±15% @500Ω<br>Not Sated in the manual<br>Not Sated in the manual |
| 17. | Pulse<br>Duration<br>(µsec) | Positive | Section A:<br>Multiplier x 1:<br>700µs±10%<br>Multiplier x 10:<br>500µs±10% | Section B | 100µs |
| | | Negative | Section A:<br>4 x (+Phase) | Section B<br>4 x (+Phase) | Not Sated in the manual |
| 18. | Frequency (Hz) [or Rate<br>(pps)] | | Multiplier x 1: 0~20Hz<br>Multiplier x 10: 0~200Hz | | 1~500Hz |
| 19. | Net Charge<br>(microcoulombs (µC) per<br>pulse) | | 0µC@500Ω, + and - pulses cancel | | 0µC@500Ω |
| 20. | Maximum Phase Charge,<br>(μC) | | 12.4µC | | 7.2µC |
| 21. | Maximum Current Density,<br>(mA/cm², r.m.s.) | | 17.6mA /cm² | | 25.5mA/cm² |
| 22. | Maximum Average Power<br>Density, (W/cm²) | | 0.12W/cm² | | 0.24W/cm² |
| 23 | Burst<br>Mode<br>(i.e.,<br>pulse<br>trains) | (a) Pulses per<br>burst | 2~340 (Intermittent wave, N-Saw tooth<br>wave)<br>2~400 (Rise-fall wave)<br>2-80 (I-Saw tooth wave)<br>2~380 (Rise dense-fall disperse wave, Rise<br>disperse-fall dense wave) | N/A | |
| | | (b) Bursts per<br>second | 0.3 (Intermittent wave, N-Saw tooth wave,<br>Rise-fall wave, I-Saw tooth wave, Rise<br>dense-fall disperse wave, Rise disperse-fall<br>dense wave) | N/A | |
| | | (c) Burst duration<br>(seconds) | 1.7 (Intermittent wave, N-Saw tooth wave)<br>2.0 (Rise-fall wave) | N/A | |

{5}------------------------------------------------

K12812

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

| રેસ<br>33<br>2<br>48<br>œ<br><br>0<br>2 | 1 |
|-----------------------------------------|---|
| 3<br>AW<br>4<br>1 | |

| | | 0.4 (I-Saw tooth wave) | |
|--|----------------------------------------|------------------------------------------------------------------------|-----|
| | | 1.9 (Rise dense-fall disperse wave, Rise<br>disperse-fall dense wave) | |
| | (d) Duty Cycle:<br>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, Rise<br>disperse-fall dense wave) | |

# 3.2.2 Substantial Equivalence Discussion

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

{6}------------------------------------------------

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.

{7}------------------------------------------------

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

{8}------------------------------------------------

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 [phone] or [phone] 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

{9}------------------------------------------------

# 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