JIAJIAN TENS

K112288 · Wuxi Jiajian Medical Instrument Co., Ltd. · GZJ · May 2, 2012 · Neurology

Device Facts

• Record ID: K112288
• Device Name: JIAJIAN TENS
• Applicant: Wuxi Jiajian Medical Instrument Co., Ltd.
• Product Code: GZJ · Neurology
• Decision Date: May 2, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Indications for 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 Story

Battery-powered portable TENS device; delivers electrical current to nerves/muscles via skin-applied electrodes. User interface includes display screen, menu keys (program selection/editing/locking), and intensity adjustment keys. Features 12 selectable programs across 4 modes: Normal, Burst, Rate & Width Modulation, and Intensity Modulation. Operated by patient or clinician; electrodes (min 8cm2) connected via lead wires. Device provides symptomatic pain relief; output parameters (voltage, current, pulse width/rate) are user-adjustable. Benefits include non-invasive pain management.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 (General safety), IEC 60601-2-10 (Particular requirements for nerve/muscle stimulators), and IEC 60601-1-2 (Electromagnetic compatibility). No clinical data presented.

Technological Characteristics

Battery-powered (9V 6F22) portable stimulator. ABS injection-molded housing. Microprocessor-controlled voltage output. 2 output channels (transformer isolated). 12 programs, 4 modes. Pulse width 60-300μS, rate 0.5-120Hz. Complies with IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2.

Indications for Use

Indicated for symptomatic relief of chronic intractable pain and adjunctive treatment for post-surgical and post-traumatic pain in patients requiring transcutaneous electrical nerve stimulation.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• TENS, Model EV-804 (K071951)

Submission Summary (Full Text)

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

Wuxi Jiajian Medical Instrument Co., Ltd Qinghong Rd., Ehu Town, Xishan District, Wuxi, China Phone: [phone] | Fax: [phone] | URL: http://www. jjmed.cn

# ILA (/an a

### Section 5 510(k) Summary [As required by 21 CFR 807.92]

[As required by 21 CFR 807.92

| 1. Submission Information: | |
|------------------------------|-------------------------------------------------------------------------------|
| 510(k) Number: | K112288 |
| Date: | March 15th, 2012 |
| Type of 510(k) Submission: | Traditional |
| Basis for 510(k) Submission: | New device |
| Submitter/Manufacturer: | Wuxi Jiajian Medical Instrument Co., Ltd |
| | Qinghong 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 201600 |
| | E-mail: [e-mail] |
| | Tel: [phone] |
| | Fax: [phone] |
| | |

2. Device Description: Proprietary Name: Common Name: Classification Name: Regulation Number: Product Code: Device Class: Review Panel: Device Description:

Jiajian® TENS TENS (Transcutaneous Electrical Nerve Stimulator) Transcutaneous electrical nerve stimulator for pain relief 882.5890 GZJ II Neurology

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.

l

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

Wuxi Jiajian Medical Instrument Co., Ltd na (Juan a Qinghong Rd., Ehu Town, Xishan District, Wuxi, China Phone: [phone] | Fax: [phone] | URL: http://www.jjmed.cn 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). Jiajian® TENS is an electrical nerve stimulator indicated for use for pain relief Indications for use: 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.

#### 3. Substantial Equivalence to Predicate device:

Detailed comparison data is included in "Section 9 - Substantial Equivalence Discussion" of this 510(k) submission.

| Parameters | | New Device | Predicate Device | |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| 1. | 510(k) Number: | K112288 | K071951 | |
| 2. | Device Name | Jiajian® TENS | TENS, Model EV-804 | |
| 3. | Manufacturer | Wuxi Jiajian Medical<br>Instrument Co., Ltd | Everyway Medical Instruments<br>Co., Ltd | |
| 4. | Accessories | Electrode cables and batteries | Electrodes, gel, electrode<br>cables and batteries | |
| 5. | Intended use | For symptomatic relief of<br>chronic intractable pain and<br>adjunctive treatment in the<br>management of post surgical<br>and post traumatic pain. | For symptomatic relief and<br>management of chronic<br>intractable pain, adjunctive<br>treatment in the management<br>of post surgical and post<br>traumatic pain | |
| 6. | Power Source(s) | 9V Battery type 6F22 | 9V Battery type 6F22 | |
| | - Method of Line Current Isolation | N/A | N/A | |
| | - Patient Leakage Current | | | |
| | - Normal Condition (μA) | 2μA | N/A | |
| | - Single Fault Condition (μA) | N/A | N/A | |
| 7. | Average DC current through electrodes<br>when device is on but no pulses are being<br>applied (μA) | <0.01μA | <0.01μA | |
| 8. | Number of Output Modes | 4 | 5 | |
| 9. | Number of Output channels: | 2 | 2 | |
| | - Synchronous or Alternating? | Synchronous | Synchronous | |
| | - Method of Channel Isolation | By Transformer | By Transformer | |
| 10. | Regulated Current or Regulated Voltage? | Voltage control | Voltage control | |
| 11. | Software/Firmware/Microprocessor<br>Control? | Yes | Yes | |
| 12. | Automatic Overload Trip? | No | No | |
| 13. | Automatic No-Load Trip? | No | No | |
| 14. | Automatic Shut Off? | Yes | No | |
| 15. | User Override Control? | No | No | |
| 16. | Indicator | On/Off Status? | Yes | Yes |
| | Display: | Low Battery? | Yes | Yes |
| | | Voltage/Current Level? | Yes | Yes |
| 17. | Timer Range (minutes) | | 30 min or 1~99 min | 5~60min or continuous, 5 min/step |
| 18. | Compliance with Voluntary Standards? | | IEC 60601-1; IEC 60601-1-2; IEC 60601-2-10 | IEC 60601-1; IEC 60601-1-2 |
| 19. | Compliance with 21 CFR 8988? | | Yes | Yes |
| 20. | Weight (grams) | | 170g without battery | 115g (battery included) |
| 21. | Dimensions (mm) [W x H x D] | | 114*59*27 mm | 101*61*24.5mm |
| 22. | Housing Materials & Construction | | ABS; Injection molded | ABS; Injection molded |
| 23. | Waveform | | Monophasic | Asymmetrical biphasic |
| 24. | Shape | | Rectangular pulse | Rectangular pulse |
| 25. | Maximum Output Voltage (volts) | | 36V @500Ω | 50 V @500Ω |
| 26. | Maximum Output Current (specify units) | | 72mA @500Ω | 100mA @500Ω |
| 27. | Pulse Duration (μsec) | | The range of Pulse width control is between 60μS and 300μS. | The range of Pulse width control is between 50μS and 300μS. |
| 28. | Frequency (Hz) [or Rate (pps)] | | The range of Pulse rate control is between 0.5Hz and 120 Hz. | The range of Pulse rate control is between 2Hz and 150 Hz. |
| 29. | Net Charge (μC per pulse) | | 0.7776μC @500Ω | 0.945μC @500Ω |
| 30. | Maximum Phase Charge, (μC) | | 21.6μC @500Ω | 30μC @500Ω |
| 31. | Maximum Average Current, (mA) | | 2.592mA @500Ω | 4.5 mA @500Ω |
| 32. | Maximum Current Density, (mA/cm², r.m.s.) | | 1.71mA/cm² @500Ω | 1.33mA/cm² @500Ω |
| 33. | Maximum Average Power Density, (W/cm²) | | 11.73mW/cm² @500Ω | 3.7mW/cm² @500Ω |
| Substantial Equivalence Discussion: | | | | |
| Similarities between New device and Predicate Device: | | | intended use, power supply, output modes, output channels, pulse width control, pulse rate control, with microprocessor control, testing standards | |
| Differences between New device and Predicate Device: | | | weight, dimensions, waveform, output voltage and current, net charge | |
| Conclusion: | | The maximum output voltage, maximum output current, and maximum phase charge of the new device are smaller than the predicate device. The maximum current density and maximum average power density are larger than the predicate device, but the values conform to the safety requirements of FDA regulation. In all important respects, the Jiajian® TENS are substantially equivalent to the TENS EV-804 (K071951). This conclusion is based upon comparison on design, technical characteristics, output mode, intended use, and safety standards complied with. Any differences in the technological characteristics do not raise any new safety and | | |

2

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

K112288

Wuxi Jiajian Medical Instrument Co., Ltd
Qinghong Rd., Ehu Town, Xishan District, Wuxi, China
Phone: [phone] | Fax: [phone] | URL: http://www. jjmed.cn

*ILAGUAN*
HERBY

3 '

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

IVACUAN
BERRY

ব

#### 4. Safety and Effectiveness of the device:

Jiajian® TENS is safe and effective as the predicate devices cited above.

The new device has passed testing according to the safety standards:

* 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 conclusion drawn from the safety testing is that the new device is substantially equivalent to the predicate device. Furthermore, the new device complies with the recognized standards and performs its intended tasks as well as the legally marketed predicate devices.

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY - 2 2012

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

Re: K112288

Trade/Device Name: Jiajian® TENS Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: II Product Code: GZJ Dated: Not Dated Received: April 17, 2012

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 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

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

Page 2 - Ms. Doris Dong

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/CDRH/CDRHOffices/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## Section 4 Indications for Use Statement

510(k) Number (if known):

K

Device Name:

Jiajian® TENS

Indications for 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.

Prescription Use ___ V (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)

CILC
(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K112288

Page 1 of 1