ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR

K110390 · Handelshaus Dittman GmbH · GZJ · Jul 29, 2011 · Neurology

Device Facts

• Record ID: K110390
• Device Name: ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR
• Applicant: Handelshaus Dittman GmbH
• Product Code: GZJ · Neurology
• Decision Date: Jul 29, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Care back pain relief stimulator is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain form exercise or normal household and working activities.

Device Story

Care back pain relief stimulator (models TENS 7000, LT3074) is a non-invasive transcutaneous electrical nerve stimulator (TENS) for over-the-counter use. The device consists of a stimulation unit, support belt, electrodes, and snap cables. Electrodes are sewn into the support belt, which is worn on the lower back. The device delivers electrical pulses to the treatment area to provide temporary pain relief. Users operate the device to manage muscle soreness and aching resulting from exercise or daily activities. The device is powered by 9V or 4.5V batteries. It provides adjustable pulse width, frequency, and timer settings. Healthcare providers do not operate the device; it is intended for patient self-use. The device benefits patients by providing a non-pharmacological option for managing lower back pain.

Clinical Evidence

Bench testing only. No clinical data was conducted or relied upon. Conformity to voluntary standards (IEC60601-1, IEC60601-1-2, IEC60601-2-10, ISO 10993, ISO 14971) and software verification per FDA guidance were provided.

Technological Characteristics

Transcutaneous electrical nerve stimulator. Enclosure: ABS plastic (UL 94V-1). Electrodes: Rubber or fabric. Power: 9V (TENS 7000) or 4.5V (LT3074) battery. Output: 2-150Hz frequency, 50-300us pulse width. Compliance: IEC60601-1, IEC60601-1-2, IEC60601-2-10. Sterilization: Not applicable (non-invasive).

Indications for Use

Indicated for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and working activities.

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

• Low Back Pain Relief System (K060222)

Submission Summary (Full Text)

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K110390

File No: WMI-04-OTCT -FDA-05 Version: 1.3

JUL 2 9 2011

)

# 510(k) SUMMARY

Care back pain relief stimulator, K (

07/27/2011 Date of Submission: Shenzhen Dongdixin Technology Co., Ltd. 510(k) Submitter's Name: No.3bldg. xiliyangguang industrial Estae xilixiaobaimang Nanshan district Shenzhen, China Address: 518108 [phone] Telephone: Fax: [phone] 510(k) Correspondent Kang Jian Ping contact: [e-mail] E-mail:

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#### 1. Proposed Device:

| Trade Name: | Care back pain relief stimulator |
|----------------------|------------------------------------|
| Model: | TENS 7000,LT3074 |
| Classification Name: | Stimulator, Nerve, Transcutaneous. |
| | Over-The-Counter |
| Regulation Number: | 21CRF 882.5890 |
| Product Code: | NUH |
| Device Class: | II |

#### 2. Predicate Device:

| Predicate Device: | Low Back Pain Relief System |
|-------------------|-----------------------------|
| 510(k) Number: | K060222 |
| Manufacturer: | Gemore Technology Co.,Ltd |

#### 3. Description of Proposed Device:

Care back pain relief stimulator, which includes models TENS 7000 and LT3074 are non-invasive devices which are tented for over the counter use in temporary relief of pain associated with sore and aching muscles in the lower back due to strain form exercise or normal household and working activities.

The devices contain the following main parts: TENS stimulation unit, Support Belt, electrode, and snap cable.

The electrode is permanently sewn up in the support belt. Each belt is flexible, and is available in range of sizes to ensure good patient contact. A male snap connector is placed within the electrode and is connected via the female snap connector to a short lead wire. The lead wire has a female pin connection at the distal end which accepts the lead wire connection from the stimulator.

The device can be worn on the low back part of user so as to place the electrode on the treatment location of low back.

#### 4. Proposed Device Intended Use Statement:

Care back pain relief stimulator is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain form exercise or

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normal household and working activities.

#### Technological Characteristics: 5.

Both the stimulator and the Predicate device stimulator have the same intended use and fundamental technology. A side-by-side comparison of the technological characteristics of the care back pain relief and the cited predicate devices is included in the 510(k) submission.

| Parameter | Care back pain relief stimulator<br>Model: TENS7000,LT3074 | Low Back Pain Relief<br>System, model<br>GM320PP |
|------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Care back pain relief stimulator is<br>intended for temporary relief of<br>pain associated with sore and<br>aching muscles in the lower back<br>due to strain form exercise or<br>normal household and working<br>activities. | The model GM320PP is<br>intended for temporary<br>relief of pain associated<br>with sore and aching<br>muscles in the lower back<br>due to strain from exercise<br>or normal household and<br>work activities. |
| Power Source | 9V Battery for TENS7000<br>4.5V Battery for LT3074 | 9V Battery |
| Max Output Voltage (V)<br>±20% | 40.0V@500Ω for TENS 7000 | 40.0V@500Ω |
| | 45.0V@500Ω for LT3074 | |
| | 100.0V@2kΩ for TENS 7000 | 120.0V@2kΩ |
| | 50.0V@2kΩ for LT3074 | |
| | 110.0V@10kΩ for TENS 7000 | 150.0V@10kΩ |
| | 60.0V@10kΩ for LT3074 | |
| Max Output Current (mA)<br>±20% | 80.0mA @500Ω for TENS 7000 | 80.0 mA @500Ω |
| | 90.0mA @500Ω for LT3074 | |
| | 50.0mA @2kΩ for TENS 7000 | 60.0 mA @2kΩ |
| | 25.0mA @2kΩ for LT3074 | |
| | 11.0mA @10kΩfor TENS 7000 | 15.0 mA @10kΩ |
| | 6.0mA @2kΩ for LT3074 | |
| Pulse Width Range | 50-300us for TENS 7000<br>50-250us for LT3074 | 150-260 us |
| Frequency | 2-150Hz for TENS 7000<br>2-110Hz for LT3074 | 2-120Hz |
| Timer Range (minutes) | 5 - 60 minutes or Continuous fo<br>TENS7000<br>30 minutes for LT3074 | 15min, 30min, 60min<br>and continuous |
| Maximum Average Current<br>(average absolute value),<br>mA (refer to the remark 1) | 3.6mA,500Ω, for TENS 7000<br>2.5mA,500Ω, for LT3074 | 2.5mA,500Ω |
| RMS current (refer to the remark 1) | 17.0 mA.r.m.s for TENS 7000 | 20.0 mA.r.m.s |
| | 14.2 mA.r.m.s for LT3074 | |
| | | |
| Maximum Current Density<br>(refer to the remark 1) | $0.56mArms/cm^2,500Ω$ for TENS<br>7000<br>$0.14mArms/cm^2,500Ω$ for LT3074 | $0.56mArms/cm^2,500Ω$ |
| Maximum Power Density<br>(refer to the remark 1) | $4.8mWrms/cm^2,500Ω$ for TENS<br>7000<br>$1.0mWrms/cm2,500Ω$ for LT3074 | $3.3mWrms/cm^2,500Ω$ |
| Compliance with Voluntar<br>Standards? | IEC60601-1, IEC60601-1-2<br>IEC60601-2-10 | IEC60601-1, IEC60601-1-2<br>IEC60601-2-10 |
| Compliance with 21 CFR<br>898? | Yes | Yes |
| Weight (grams.) | 150 grams with battery for<br>TENS7000<br>80 grams with battery for LT3074 | 140 grams with battery |
| Dimensions (mm.) H x W x T | 101*61*24.5cm for TENS7000<br>85*72*30cm for LT3074 | 108*61.5*25 |
| Housing Materials &<br>Construction | Enclosure: ABS,94V-1,80°C,UL<br>Approved | Enclosure:<br>ABS,94V-1,80°C,UL<br>Approved |
| Materials of electrodes: | Rubber or fabric | Gel |

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#### File No: WMI-04-OTCT -FDA-05 Version: 1.3

#### Non-Clinical Tests Performed: 6.

Care back pain relief stimulator did not conduct, nor rely upon, clinical tests to determine substantial equivalence. Care back pain relief stimulator has received test reports certifying that the Care back pain relief stimulator was tested and found to be in conformity with voluntary standards includes IEC60601, IEC60601-1-2, IEC60601-2-10, ISO 10993 and ISO14971. The software verification has been carried out according to the FDA Guidance of the content of Premarket submissions for the software contained in Medical Devices. This test reports have provided as part of this premarket notification.

### 7. Conclusions:

The Care back pain relief Stimulator, which includes models TENS 7000 and LT3074, has the same intended use and technological characteristics as the cited predicate device. Moreover, bench testing, safety report and Risk Analysis Report documentation supplied in this submission demonstrates that the difference in the submitted models could maintain the same safety and effectiveness as that of the cited predicate device. In the other words, those engineering difference do not affect the intended use or alter the fundamental scientific technology of the device. Thus, the care back pain relief stimulator is substantially equivalent to the predicate device.

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File No: WMI-04-OTCT -FDA-05 Version: 1.3

#### Remark 1

#### TENS 7000 sample calculations:

Maximum Average Current=I max*pulse rate*pulse width=80mA*150Hz*300us*$10^{-6}$=3.6mA

300us * 80mA = 17.0mA.r.m.s Ir.m.s = 150 Hz * 1000000 17.0mArm.s Ir.m.s Maximum Current Density = = 0.56mA.r.m.s/$cm^2$ 30cm2 S 300us Vr.m.s * 40V = 8.5V r.m.s 150Hz 10000000 8.5Vr.m.s Vr.m.s Maximum Voltage Density = = 0.28V r.m.s/$cm^2$ 30cm2 S Vr.m.s * Ir.m.s 8.5Vr.m.s * 17mAr.m.s Maximum Power Density = = 4.8mW r.m.s / cm2 S 30cm2

#### LT3074 sample calculations:

Maximum Average Current=I max*pulse rate*pulse width=90mA*100Hz*250us*10-6=2.5mA

$$Ir.m.s = \sqrt{\frac{5}{5} * 100 Hz * \frac{250us}{1000000}} * 90mA = 14.2mAr.m.s$$

$$Maximum Current Density = \frac{Ir.m.s}{S} = \frac{14.2mAr.m.s}{100cm^{2}} = 0.14mAr.m.s/cm^{2}$$

$$Vr.m.s = \sqrt{\frac{5}{5} * 100Hz * \frac{250us}{1000000}} * 45V = 7.1Vr.m.s$$

$$Maximum Voltage Density = \frac{Vr.m.s}{S} = \frac{7.1Vr.m.s}{100cm^{2}} = 0.07Vr.m.s/cm^{2}$$

$$Maximum Power Density = \frac{Vr.m.s * Ir.m.s}{S} = \frac{7.1Vr.m.s * 14.2mAr.m.s}{100cm^{2}} = 1.0mWr.m.s/cm^{2}$$

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

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

Handelhaus Dittman GMBH Shenzen Dongdixin Technology Co. LTD. c/o Mr. Kang Jiang Ping R.A. Director No. 3 Building Xiliyiangguang Industrial Estate Xillixaobaim Shenzen China 518108

JUL 2 9 2011

Re: K110390

Trade/Device Name: ETG 255 Combo Stimulator, TEN 260 Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Codes: GZJ, IPF Dated: November 30, 2011 Received: February 11, 2011

Dear Mr. Jiang Ping:

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.

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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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Keria Alexander

Malvina B. Eydelman, M.D. Director

Division of Ophthalmic, Neurological, Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number ( ):

Device Name:

ETG 255 Combo Stimulator, TEN 260 Combo Stimulator

## Indications for Use:

ETG 255 Combo Stimulator,

### For TENS mode

Symptomatic relief of chronic intractable pain, relief of acute post-surgical and posttraumatic pain.

#### For EMS mode

- 1. Relaxation of muscle spasm.
- Increase of local blood flow circulation 2.
- Prevention or retardation of disuse atrophy 3.
- Muscle re-education 4.
- Maintaining or increasing range of motion. 5.
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis 6.

### TEN 260 Stimulator

Symptomatic relief of chronic intractable pain, relief of acute post-surgical and posttraumatic pain.

Prescription Use V 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)

Division Sign Off

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K110390