4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A

K100399 · Well-Life Healthcare Limited · GZJ · Jun 25, 2010 · Neurology

Device Facts

• Record ID: K100399
• Device Name: 4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A
• Applicant: Well-Life Healthcare Limited
• Product Code: GZJ · Neurology
• Decision Date: Jun 25, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The indication for use of this device includes the prescription TENS, NMS, Interferential stimulation as follows: Transcutaneous Electrical Nerve Stimulator (TENS/IF TENS) & Program can be used for the following applications : · For symptomatic relief of chronic intractable pain. Neuromuscular electrical stimulation (NMS) & Program stimulation can be used for the following applications : - · Relax muscle spasms - · Prevent or retard disuse atrophy - Increase local blood circulation - · Re-educate muscles - Maintain or increase the range of motion

Device Story

NuvoStim IV (WL-2504A) is a 4-channel electrical stimulator providing TENS, NMS, and Interferential (IF) stimulation. Device consists of a stimulus generator and output ports; delivers adjustable electrical current via skin-attached electrodes. Operated by healthcare providers or patients (per prescription) to manage pain or stimulate muscles. Microprocessor-controlled operation modes allow customization of output waveforms and intensity. Clinical benefit includes pain relief, muscle spasm reduction, and improved muscle function. Output parameters are adjustable based on patient needs.

Clinical Evidence

Bench testing only. Compliance with ANSI/AAMI NS4-1985, EN 60601-1, and EN 60601-1-2 standards. Software validation performed per FDA guidance.

Technological Characteristics

4-channel electrical stimulator; microprocessor-controlled; TENS, NMS, and IF stimulation modes. Output current/power density measured against 500Ω load. Compliant with EN 60601-1 (safety) and EN 60601-1-2 (EMC).

Indications for Use

Indicated for patients requiring symptomatic relief of chronic intractable pain (TENS/IF TENS) or neuromuscular stimulation for muscle spasm relaxation, prevention/retardation of disuse atrophy, increased local blood circulation, muscle re-education, and maintenance/increase of range of motion (NMS).

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

• WL-2203A (K033857)
• WL-2204A (K033857)
• WL-2204A-P2 (K033857)
• WL-2206D (K092763)

Submission Summary (Full Text)

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## 510(K) Summary

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

The assigned 510(k) number is: K100399.

1. Submitter's Identifications:

| Company Name: | Well Life Healthcare Limited | | |
|-----------------|------------------------------------------------------------------|--|--|
| Contact person: | Jenny Hsieh | | |
| Address: | 1FL., No.16, Lane 454, Jungjeng Rd., Yunghe City, Taipei County, | | |
| | Taiwan, R.O.C. | | |
| TEL No.: | 886-2-2928-2112 | | |
| Fax No.: | 886-2-2928-1880 | | |
| E-mail address: | [e-mail] | | |

- 2. Name of the Device:
4 Channels Multiple Modes Electrical Stimulator/ Model: NuvoStim IV, WL-2504A

- 3. Information of the 510(k) Cleared Device (Predicate Device):
WL-2203A (K033857), WL-2204A(K033857),WL-2204A -P2(K033857), and WL-2206D(K092763)

- 4. Device Description:
The Well-Life 4 Channels Multiple Modes Electrical Stimulator/ Model: WL-2504A is the The Well-che of Channels Matiple Motion Leorve stimulator(TEMS) and Interferential Combination (IF) used for pain relief and/or powered muscle stimulator(EMS) by applying Stimulation (if ) ascu for pain rollor which are attached on the patient's skin. The output and waveform is adjustable according to the situation of patient.

The Well-Life 4 Channels Multiple Modes Electrical Stimulator/ Model: WL-250A consisted The Well-Life + Chamble Modisle Model Eloctive. The stimulus generator generator generator summer mainly of two parts. the stimulas gonorator, close. The output port transmits the output current oulput current Specificular to the patient's skin so as to transmit this stimulus current to the patient for pain relief or muscle stimulation of intended use purpose.

The Well-Life 4 Channels Multiple Modes Electrical Stimulator/ Model: WL-2504 includes The Well-Life + Channels Modes as mentioned on the comparison table. These its moin several unlerent operation modes as montonou on the microprocessor as its main control unit.

- 5. Intended Use:
The indication for use as described hereafter :

Transcutaneous Electrical Nerve Stimulator (TENS) & Program can be used for the following applications :

Tonowing upplications intractable pain ---------------------------------------------------------------------------------------------------------------------------------------

Neuromuscular electrical stimulation (NMS) & Program stimulation can be used for the following applications :

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- Relax muscle spasms
- Prevent or retard disuse atrophy
- · Increase local blood circulation
- · Re-educate muscles
- · Maintain or increase the range of motion

### 6. Substantial Equivalence Comparison

The WL-2504A has output characteristics and controls that are identical to those of the The WL-2504A has output online of the considered as Substantial Equivalent to the function of chosen 510K chosen predicate devices:

lunction of GRSSH 8 for chools procession is substantial equivalent to WL-2203A (KO33857).

2> The NMS function of WL-2504A is substantial equivalent to WL-2204A (K033857).

2> The Nill Tunction of WL-2504A is substantial equivalent to WL-2204A-P2 (K03387).

4> The IF TENS function of WL-2504A is substantial equivalent to WL-2206D (K092763).

## 7. Output Performance Range for each Operation Mode

- Current Density Range: Unit mA/cm²..(measured against 500Ω loading at maximum . oulse rate).

| Function | Operation Function | | | |
|----------|--------------------|---------|---------|-------------|
| | IF TENS | TENS | EMS | Pre-program |
| Minimum | < 0.001 | < 0.001 | < 0.001 | < 0.001 |
| Moderate | 0.0281 | 0.09 | 0.1125 | 0.09 |
| Maximum | 0.1125 | 0.18 | 0.225 | 0.18 |

- Power Density Range: Unit W/cm² (measured against 500Ω loading at maximum pulse rate).

| Function | Operation Function | | | |
|----------|--------------------|---------|---------|-------------|
| | IF TENS | TENS | EMS | Pre-program |
| Minimum | < 0.001 | < 0.001 | < 0.001 | < 0.001 |
| Moderate | 0.0281 | 0.0018 | 0.00281 | 0.0018 |
| Maximum | 0.1125 | 0.0072 | 0.01125 | 0.0072 |

- 8. 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 EN 60601-1, and EN 60601-1-2 requirement.

In addition to the compliance of voluntary standards, the risk assessment has been carried in addition to the compliance of volunally clanted verification has been carried out according to the FDA software validation guidance.

- 9. Conclusions
Conclusions
The 4 Channels Multiple Modes Electrical Stimulator , model WL-2504A , has the same The 4 Channels Multiple Mouter Liectives Citing of Children of WL-2203A (K033857),
intended use and technological characteristics as the cleared device of Mercever intended use and technological characteriorions and WL-2206D (K092763). Moreover, WL-2204A (K035657),VL-2204/ 1 2(1000001)), at this submission demonstrate that the difference ventication and validation tests containous 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

JUN 2 5 2010

Well-Life Healthcare Limited c/o Ms. Jenny Hsieh Official Correspondent 1FL, No.16, Lane 454, Jungjeng Road Yunghe City, Taipei County China (Taiwan)

Re: K100399

Trade/Device Name: 4 Channels Multiple Modes Electrical Stimulator / Model: NuvoStim IV, WL-2504A Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Codes: GZJ, IPF, LIH Dated: May 27, 2010 Received: May 28, 2010

Dear Ms. Hsieh:

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. Iisting 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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Page 2 - Ms. Jenny Hsieh

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 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/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

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# Indications For Use

#### k 100399 510(k) Number (if known):

Device Name: 4 Channels Multiple Modes Electrical Stimulator / Model: NuvoStim IV, WL-2504A

### Indications For Use:

The indication for use of this device includes the prescription TENS, NMS, Interferential stimulation as follows:

Transcutaneous Electrical Nerve Stimulator (TENS/IF TENS) & Program can be used for the following applications :

· For symptomatic relief of chronic intractable pain.

Neuromuscular electrical stimulation (NMS) & Program stimulation can be used for the following applications :

- · Relax muscle spasms
- · Prevent or retard disuse atrophy
- Increase local blood circulation
- · Re-educate muscles
- Maintain or increase the range of motion

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number