OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406

K052785 · Well-Life Healthcare Limited · NUH · Mar 17, 2006 · Neurology

Device Facts

• Record ID: K052785
• Device Name: OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406
• Applicant: Well-Life Healthcare Limited
• Product Code: NUH · Neurology
• Decision Date: Mar 17, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The model WL-2406 TENS is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities

Device Story

Dual-channel, 3V battery-operated TENS device; intended for OTC use for lower back pain relief. Device delivers electrical stimulation via an electrode belt. User selects from 8 pre-programmed waveforms (P1-P8); output strength adjustable 0-50 mA; fixed 21-minute treatment timer. LCD provides status updates: mode, waveform, strength, time remaining, and low battery warning. Device provides temporary pain relief through electrical nerve stimulation. Operated by patient in home or work environment.

Clinical Evidence

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

Technological Characteristics

Dual-channel TENS; 3V battery power; electrode belt interface; 8 selectable pre-programmed waveforms; 0-50 mA output range; 21-minute fixed timer; LCD interface. Standards: ANSI/AAMI NS4-1985, EN 60601-1, EN 60601-1-2.

Indications for Use

Indicated for temporary relief of lower back pain associated with sore and aching muscles due to strain from exercise or normal household and work activities in patients using the device over-the-counter.

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-2402 (K040512)

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: K052785/S2

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- 1. Submitter's Identifications: Well Life Healthcare Limited 5FI., Ste 504, Empire Centre, 68 Mody Road, Tsimshatsuim, Kowloon, Hong Kong
Contact: Jenny Hsieh

Date of Summary Preparation: March 10, 2006.

- 2. Name of the Device:
OTC TENS for Low Back Pain Relief / Model: WL-2406.

- 3. Information of the 510(k) Cleared Device (Predicate Device):
WL-2402 (K040512).

- 4. Device Description:
The Well Life TENS devices, WL-2406 is the model of OTC TENS intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

- WL-2406 is a dual channel, 3V battery operated TENS device with the following features:
- <1> The operation mode is "Wire" with dual channels.
- <2> The stimulation electrode is connected via electrode belt for "Wire" operation mode.
- <3> The output waveform is selectable pre-programming changed amonq P1~P8.
- <4> The output strength is adjustable at 0~50 mA, with setting time 21 minutes counting from switching ON.
- <5> The LCD display is provided for the indication of operation status including operation mode. output wave form, output strength, time to cut-off, and battery low warning.

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#### 5. Intended Use:

The model WL-2406 TENS is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities

The standard format for the statement of indications and contraindication for use are provided hereafter.

#### ം. 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 software verification has been carried out according to the FDA software quidance.

#### 7. Conclusions

The OTC TENS for low back pain relief/ model WL-2406 has the same intended use and the similar technological characteristics as the cleared device of WL-2402 (k040512). 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES" is arranged in a circular pattern around the central image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 7 2008

Well-Life Healthcare, Incorporated c/o Ms. Grace Chang 1FL, No. 16, Lane 454 Jungjeng Road., Yunghe City Taipei County, Taiwan, R.O.C.

Re: K052785

Trade/Device Name: Well-Life Model WL-2406 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: II Product Code: NUH Dated: February 14, 2006 Received: February 15, 2006

Dear Ms. Chang:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it 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 device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs 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); good manufacturing practice requirements as set

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### Page 2 - Ms. Grace Chang

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 CHR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Herbert Severin us

Mark N. Melkerson, M.S. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications For Use

510(k) Number (if known): K052785/S2

Device Name: OTC TENS For Low Back Pain Relief / Model WL-2406.

Indications For Use:

- The model WL-2406 are intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use V (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)

Herbert Spencer us

(Division Sign Division of General, Restorative, and Neurological Devices

510(k) Number K052785