THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403), THE COMPACT TENS (WL-2302)

K020020 · Well-Life Healthcare, Inc. · GZJ · Dec 30, 2002 · Neurology

Device Facts

• Record ID: K020020
• Device Name: THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403), THE COMPACT TENS (WL-2302)
• Applicant: Well-Life Healthcare, Inc.
• Product Code: GZJ · Neurology
• Decision Date: Dec 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Mini-TENS series including WL-2401, WL-2402, WL-2403, and WL-2302, is a portable, batterypowered, transcutaneous electrical nerve stimulators (TENS device) that are used in the treatment of pain syndromes, that is intended for use on intact skin, and that do not require surgical intervention or violation of the skin surface.

Device Story

Portable, battery-powered TENS device for pain relief; applies electrical current to electrodes attached to patient's intact skin. Stimulus generator produces adjustable output current; transmitted via output port to electrodes. Operates in burst mode with fixed pulse rate, frequency, and timer; amplitude is user-adjustable. Used by patients for symptomatic relief of chronic intractable pain. Device models (WL-2401, WL-2402, WL-2403, WL-2302) vary by stimulation cycle, waveform combinations, and timer settings. Healthcare providers prescribe device; patient applies electrodes and adjusts amplitude for pain management. Benefits include non-invasive, drug-free pain relief.

Clinical Evidence

Bench testing only. Verification and validation tests confirm performance specifications and safety compliance with ANSI/AAMI NS4-1985, EN 60601-1, EN 60601-1-1, and EN 60601-1-2. No clinical data presented.

Technological Characteristics

Portable TENS device; plastic housing; 3V Lithium battery power. Biphasic, rectangular waveform output. Regulated current (RC) delivery. Type BF applied part. Connectivity: standalone. Sterilization: not applicable (electrodes provided). Firmware-controlled stimulation cycles. Dimensions vary by model (e.g., 60x47.3x14.6mm to 56x26x8mm).

Indications for Use

Indicated for symptomatic relief of chronic intractable pain in patients requiring non-surgical, non-invasive 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

• Well-TENS WL-2102A (K002874)

Submission Summary (Full Text)

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## 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: _K020020

DEC 3 0 2002

1. Submitter's Identifications: Well-Life Healthcare Inc. Room 6C01, No. 5, Sec. 5, Hsin Yi Rd., Taipei, Taiwan, R.O.C.

Contact: Ms. Grace Chang Sales Manager

Date of Summary Preparation: October, 2001.

- 2. Name of the Device: Well-Life TENS (Transcutaneous Electrical Nerve Stimulation Device), Model Mini-TENS series. including WL-2401, WL-2402, WL-2403, and WL-2302.
- 3. Information of the 510(k) Cleared Device (Predicate Device):

## 4. Device Description:

The Mini-TENS series, including WL-2401, WL-2402, WL-2403, and WL-2302 are transcutaneous electrical nerve stimulator used for pain relief by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the situation of patient.

Mini-TENS series, models WL-2401, WL-2402, WL-2403, and WL-2302, consist mainly of two parts: the stimulus generator, electrode. The stimulus generator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the patient's skin so as to transmit this stimulus current to the patient for pain relief.

The stimulation mode for Mini-TENS is burst mode with fixed pulse rate, frequency, and fixed timer. Only amplitude is adjustable. This operation way is considered the simplification from the burst mode of comparison clear model, WL-2102A. Every model of Mini-TENS has its individual stimulation operation cycle.

The Mini-TENS series (WL-2401, WL-2402, WL-2403, and WL-2302) are almost identical in function outlook and specification. The main differences between these four models are indicated in the following table.

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| Model | Outlook | Time for<br>each<br>operation<br>cycle | Combination of<br>wave form | Wave form information | | | |
|----------------------|---------|----------------------------------------|--------------------------------------------------------------------------|-----------------------|----------------------|------------------------|------------------|
| | | | | Type | Pulse rate<br>(Hz) | Pulse width<br>(μs) | Time<br>duration |
| Mini-TENS<br>WL-2401 | Type A | 60<br>minutes | Single wave<br>form (A) | A | 30 | 250 | 3s/ON,<br>5s/OFF |
| Mini-TENS<br>WL-2402 | Type B | 15<br>minutes | A/1min→<br>B/1min→<br>C/1min, repeat 5<br>times | A | 30~60<br>auto-change | 250 | 6s/ON,<br>1s/OFF |
| | | | | B | 30 | 150~250<br>auto change | 6s/ON,<br>1s/OFF |
| | | | | C | 30~60<br>auto change | 150~250<br>auto change | 6s/ON,<br>1s/OFF |
| Mini-TENS<br>WL-2403 | Type C | 30<br>minutes | Single wave<br>form (A) | A | 25 | 115 | 4s/ON,<br>1s/OFF |
| Mini-TENS<br>WL-2302 | Type C | 15<br>minutes | A/2min→<br>B/2min→<br>C/2min→<br>B/2min→<br>D/2min→<br>B/2min→<br>C/3min | A | 2 | 115 | 2s/ON,<br>1s/OFF |
| | | | | B | 30 | 115 | 2s/ON,<br>1s/OFF |
| | | | | C | 4 | 115 | ON |
| | | | | D | 15 | 115 | 4s/ON,<br>1s/OFF |

The WL-2402 is the most complicate in these three models, so the assessment results for the features of performance and safety of this model could cover that of the other three models.

While comparing with the original 510(k) clear device, WL-2102A. The main difference between burst mode operation of WL-2102A and Mini-TENS are indicated as the following table:

| Comparison<br>features | Clear model | New models | | | |
|---------------------------------------------|-----------------------------|----------------------|----------------------------------------------------------------|----------------------|---------------------------------------------------------------------------------------|
| | WL-2102A | WL-2401 | WL-2402 | WL-2403 | WL-2302 |
| Timer control | 15/30/60 mins<br>adjustable | 60 mins fixed | 15 mins fixed | 30 mins fixed | 15 mins fixed |
| Burst duration<br>time | 0.1s/ON,<br>0.4s/OFF | 3s/ON, 5s/OFF | 6s/ON, 1s/OFF | 4s/ON, 1s/OFF | 2s/ON, 1s/OFF<br>or 4s/ON,<br>1s/OFF or<br>always ON |
| Pulse rate<br>(Hz) | 100Hz fixed | 30Hz fixed | 30~60Hz auto<br>change | 25Hz fixed | 2/4/15/30 Hz<br>auto change |
| Pulse width<br>(μs) | 0~260μs<br>adjustable | 250μs fixed | 150~250μs<br>auto change | 115μs fixed | 115μs fixed |
| Amplitude<br>(mA) | 0~80mA<br>adjustable | 0~50mA<br>adjustable | 0~50mA<br>adjustable | 0~50mA<br>adjustable | 0~50mA<br>adjustable |
| Combination<br>for the type of<br>wave form | Single (A) | Single (A) | 3 wave forms<br>combination:<br>A(1m)→B(1m)→C(1m), 5<br>repeat | Single (A) | 4 wave forms<br>combination:<br>A(2m)→B(2m)→<br>C(2m)→B(2m)→<br>D(2m)→B(2m)→<br>C(3m) |

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**ANNEX II**

## 5. Intended Use:

Mini-TENS series including WL-2401, WL-2402, WL-2403, and WL-2302, is a portable, batterypowered, transcutaneous electrical nerve stimulators (TENS device) that are used in the treatment of pain syndromes, that is intended for use on intact skin, and that do not require surgical intervention or violation of the skin surface.

The electrode is included in the packing of Mini-TENS series.

Because that all the performances tested are completely within the limit of standard, and all the labeling is provided according to the requirement of standard, the Well-TENS series fall completely within the scope of clause 1 of ANSI/AAMI NS4-1985.

## 6. Comparison to the 510(k) Cleared Device (Predicate Device):

| Features | Clear model | New model | | | | |
|------------------------------------------------------------------------------------|-----------------------------------|-------------------------|-------------------------|-------------------------|-------------------------|--|
| | WL-2102A | WL-2401 | WL-2402 | WL-2403 | WL-2302 | |
| 1. 510(k) Number | K002874 | K020020 | K020020 | K020020 | K020020 | |
| 2. Device Name, Model | Well-TENS,<br>WL-2102A | Mini-TENS,<br>WL-2401 | Mini-TENS,<br>WL-2402 | Mini-TENS,<br>WL-2403 | Mini-TENS,<br>WL-2302 | |
| 3. Manufacturer | Well-Life | Well-Life | Well-Life | Well-Life | Well-Life | |
| 4. Power Source(s)<br>- Method of Line Current<br>Isolation | 1x9V Alkaline<br>Type BF | 1x3V Lithium<br>Type BF | 1x3V Lithium<br>Type BF | 1x3V Lithium<br>Type BF | 1x3V Lithium<br>Type BF | |
| Normal condition<br>Single fault condition | < 0.001mA<br>Not tested | < 0.001mA<br>Not tested | < 0.001mA<br>Not tested | < 0.001mA<br>Not tested | < 0.001mA<br>Not tested | |
| 5. Number of Output Modes | 3 (B/C/M) | 1 (Burst<br>mode) | 1 (Burst<br>mode) | 1 (Burst<br>mode) | 1 (Burst<br>mode) | |
| 6. Number of Output Channels<br>- Synchronous or | 2 | 1 | 1 | 1 | 1 | |
| Alternating?<br>- Method of Channel<br>Isolation | Synchronous<br>Type BF | Synchronous<br>Type BF | Synchronous<br>Type BF | Synchronous<br>Type BF | Synchronous<br>Type BF | |
| 7. Regulated Current or<br>Regulated Voltage? | RC | RC | RC | RC | RC | |
| 8. Software/Firmware/microproc<br>essor Control? | Firmware | Firmware | Firmware | Firmware | Firmware | |
| 9. Automatic Overload Trip? | No | No | No | No | No | |
| 10. Automatic No-Load Trip? | No | No | No | No | No | |
| 11. Automatic Shut Off? | Yes | Yes | Yes | Yes | Yes | |
| 12. Patient Override Control? | No | No | No | No | No | |
| 13. Indicator Display:<br>On/Off Status?<br>Low Battery?<br>Voltage/Current Level? | Yes<br>No<br>No | Yes<br>No<br>No | Yes<br>No<br>No | Yes<br>No<br>No | Yes<br>No<br>No | |
| 14. Timer Range | 15/30/60<br>minutes<br>adjustable | 60 minutes | 15 minutes | 30 minutes | 15 minutes | |

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| | Clear model | New model | WL-2401 | WL-2402 | WL-2403 | WL-2302 |
|--------------------------------------------------------------------------------------|------------------|------------------|------------------|------------------|------------------|---------|
| Features | WL-2102A | | | | | |
| 15. Compliance with Voluntary<br>Standards? | ANSI/AAMI<br>NS4 | ANSI/AAMI<br>NS4 | ANSI/AAMI<br>NS4 | ANSI/AAMI<br>NS4 | ANSI/AAMI<br>NS4 | |
| 16. Compliance with 21 CFR<br>898? (*Becomes<br>mandatory beginning May,<br>9, 2000) | Yes | No | No | No | No | |
| 17. Weight (g) | 135 | 19 | 19 | 19 | 19 | |
| 18. Dimensions (in) [W×H×D] | 92×62×25 | 60×47.3×14.<br>6 | 60×47.3×14.<br>6 | 56×26×8 | 56×26×8 | |
| 19. Housing Materials and<br>Construction | Plastic | Plastic | Plastic | Plastic | Plastic | |

# Table for the comparison of output specifications for mini TENS

| | Clear model | New model | | | |
|--------------------------------------------------------------|----------------------|-------------|-----------------------|-------------|----------------------------|
| Specification | WL-2102A | WL-2401 | WL-2402 | WL-2403 | WL-2302 |
| Waveform<br>(e.g., pulsed monophasic, biphasic) | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic |
| Shape<br>(e.g., rectangular, spike, rectified<br>sinusoidal) | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular |
| Maximum Output Voltage (+/-20%) | | | | | |
| @ 500 Ω | 38V | 32V | 32V | 38.2V | 38.2V |
| @ 2 kΩ | 55V | 42V | 42V | 52.8V | 52.8V |
| @ 10 KΩ | 130V | 80.8V | 80.8V | 84.8V | 84.8V |
| Maximum Output Current (+/-20%) | | | | | |
| @ 500 Ω | +76mA | +64mA | +64mA | +76.2mA | +76.2mA |
| @ 2 kΩ | +55mA | +42mA | +42mA | +52.8mA | +52.8mA |
| @ 10 KΩ | +13mA | +8.08mA | +8.08mA | +8.48mA | +8.48mA |
| Pulse Width (us) | 30-260<br>adjustable | 250 | 150~250<br>changeable | 250 | 250 |
| Frequency (Hz) | 2-150<br>adjustable | 30 | 30-60<br>changeable | 25 | 2, 4, 15, 30<br>changeable |
| Beat Frequency<br>(for interferential modes only) | NA | NA | NA | NA | NA |
| Symmetrical phases<br>(for multiphasic waveform only)? | NA | NA | NA | NA | NA |
| Phase Duration<br>(for multiphasic waveform only) | NA | NA | NA | NA | NA |
| Net Charge (µ C per pulse) @500 Ω | 20.8 | 16.0 | 16.0 | 8.76 | 8.76 |
| Maximum phase Charge (µC) | 22 | 12.5 | 12.5 | 9.2 | 9.2 |
| Maximum Current Density (mA/cm²) | 0.18525 | 0.0333 | 0.0265 | 0.006 | 0.007 |
| Maximum Power Density (W/cm²) | 0.0070395 | 0.0010656 | 0.000848 | 0.0002292 | 0.0002674 |

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## 7. Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:

Compliance to applicable voluntary standards includes ANSI/AAMI, NS4-1985, as well as E.N 60601-1, EN 60601-1-1, and EN 60601-1-2 requirement.

### 8. Conclusions

The Mini-TENS series transcutaneous electrical nerve stimulator, WL-2401, WL-2402, and WL-2403, and WL-2302, have the same intended use and technological characteristics as the cleared device WL-2102A. Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device.

In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Mr. Tony C. S. Chang Wincent Consultant Co., Ltd. No. 5. Alley 5. Lane Cheng Hsing, Chung Ching Road, Pei Tun District, Taichung, Taiwan, R.O.C.

Re: K020020

Trade/Device Name: Mini-TENS Series TENS Devices Models WL-2401, WL-2402, WL-2403, WL-2302 Regulation Number: 21 CFR 882.5890 Regulation Name: TENS Device for Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: December 11, 2002 Received: December 12, 2002

Dear Mr. Chang:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, 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.

If your devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to such 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 devices 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 devices comply with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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Page 2 - Mr. Tony C. S. Chang

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); 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.

This letter will allow you to begin marketing your devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours.

Matt-1-Mather-

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page

510(k) Number (if known) k020020

Device Name:__Mini-TENS / Model: WL-2401, WL-2402, WL-2403, WL-2302

Indications For Use:

The Mini-TENS including a series of TENS models (WL-2401, WL-2402, WL-2403, and WL-2302) is intended for symptomatic relief of chronic intractable pain.

J. Hall of Williams

ivision Sign-Off) Division of General, Restorative and Neurological Devices

10(k) Number K020020

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X OR

Over-The-Counter Use

(Optional Format 1-2-96)