OTC PATCH
Device Facts
| Record ID | K133723 |
|---|---|
| Device Name | OTC PATCH |
| Applicant | Well-Life Healthcare Limited |
| Product Code | NUH · Neurology |
| Decision Date | Jan 28, 2014 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 882.5890 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The OTC Patch, Model WL-2406, is intended for temporary relief of pain associated with sore and aching muscles in the low back and/or upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
Device Story
The OTC Patch (Model WL-2406) is a single-channel transcutaneous electrical nerve stimulator (TENS) designed for OTC pain relief. The device consists of a stimulus generator and electrodes applied to the user's skin. It delivers pre-programmed, fixed-waveform electrical pulses to the treatment site. Users can adjust the intensity (amplitude) of the stimulation, while pulse rate, frequency, and timer settings are fixed per operation mode. The device is powered by two AAA batteries and features an automatic no-load trip and automatic shut-off. It is intended for patient self-use to manage muscle pain in the back and extremities. The device provides symptomatic relief by applying electrical current to the skin, which is intended to alleviate pain associated with muscle strain.
Clinical Evidence
Bench testing only. The device demonstrated compliance with voluntary standards including IEC 60601-2-10 (TENS safety), IEC 60601-1 (general safety), and IEC 60601-1-2 (EMC). Software verification was performed in accordance with FDA software guidance. No clinical data was required or provided.
Technological Characteristics
Single-channel TENS; ABS housing; 1.5V x 2 AAA battery power; Type BF isolation; biphasic rectangular waveform; 8 output modes; synchronous output via output coil; 10-60 minute timer; dimensions 68x60x17.5mm; weight 51.6g. Software-controlled microprocessor. Complies with IEC 60601-2-10, IEC 60601-1, and IEC 60601-1-2.
Indications for Use
Indicated for temporary relief of pain associated with sore and aching muscles in the low back, arms, and legs due to exercise, household, or work-related strain. For over-the-counter use.
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
- OTC TENS For Low Back Pain Relief/ Model WL-2406 (K052785)
- OTC TENS For Arm & Leg Pain Relief/ Model WL-2407 (K091757)
Reference Devices
- Well-Life Self Adhesive Electrode (K082065)
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: K133723 .
#### 1. Submitter's Identifications:
Well Life Healthcare Limited 1F., No. 16, Lane 454, Jungjeng Road, Yunghe City, Taipei County 234, Taiwan, ROC Contact: Jenny Hsieh Telephone: Date of Summary Preparation: November 15, 2013
#### 2. Name of the Device:
Trade/Device Name: OTC Patch, Model: WL-2406. Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator. Regulatory Class: II Product Code: NUH
#### 3. Information of the 510(k) Cleared Device (Predicate Device):
K052785: OTC TENS For Low Back Pain Relief/ Model WL-2406. K091757: OTC TENS For Arm & Leg Pain Relief/ Model WL-2407.
#### 4. Device Description:
The OTC Patch, model WL-2406 is a single channel transcutaneous electrical nerve stimulator used for pain relief by applying an electrical current to electrodes, which are attached on the user's skin. The outbut and waveform characteristic is fixed for every operation mode, only the intensity is adjustable within specified limit.
The OTC Patch, model WL-2406, 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 user's skin so as to transmit this stimulus current for pain relief.
The stimulation modes for OTC Patch is pre-program modes with fixed pulse rate, frequency, and fixed timer, only amplitude is adjustable. This operation way is considered the simplification from the pre-program modes of comparison clear model, OTC TENS For Low Back Pain Relief/ Model WL-2406(K052785). Every operation mode of OTC Patch, model WL-2406 has its individual stimulation operation cycle.
For the device included in this submission, we use the following of our 510(K) legally marketed predicate electrodes: K082065, "Well-Life Self Adhesive Electrode", CM Series/ model no. CM-130x70, size 130x70mm, snap type.
With the combination of the main device parts, the device can be placed on the treatment locations as recommended in the user manual for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
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#### ട. Intended Use:
The OTC Patch, Model WL-2406, is intended for temporary relief of pain associated with sore and aching muscles in the low back and/or upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
#### 6. Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:
Compliance to applicable voluntary standards includes IEC 60601-2-10, as well as IEC 60601-1, and IEC 60601-1-2 requirement. In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance.
Discussion: The Compliance to applicable voluntary standards as above mentioned indicates that the new device in this submission used the same standards as that of predicate device. Therefore; we consider that the compliance of standards included in our submission is adequate for the determination of substantial equivalence.
# 7. Comparison of Significant device features
| Features | 510(K) Cleared Models | New Model | |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model | WL-2406 | WL-2407 | WL-2406 |
| 510(K) No. | K052785 | K091757 | Unknown |
| Prescription or OTC | OTC | OTC | OTC |
| Indication for use | temporary relief of pain<br>associated with sore and<br>aching muscles in the low<br>back due to strain from<br>exercise or normal House-<br>hold and work activities | temporary relief of pain<br>associated with sore and<br>aching muscles in the upper<br>And lower extremities (arm<br>and/or leg) due to strain from<br>exercise or normal House-<br>hold and work activities | temporary relief of pain<br>associated with sore and<br>aching muscles in the low<br>back as well as upper and<br>lower extremities (arm and/<br>or leg) due to strain from<br>exercise or normal House-<br>hold and work activities |
| FDA product code | NUH | NUH | NUH |
| Electrode Used | Belt Electrode<br>(5 X 5 cm)/K082065 | Belt Electrode and/or<br>Self Adhesive Electrode<br>(5 X 5 cm)/K082065 | Self Adhesive Electrode<br>(13x7 cm)/K082065 |
## 8. Significant output characteristics comparison table:
| Comparison feature | 510(K) Cleared Model | New Model | | |
|----------------------|----------------------|--------------------|--------------------|---------------------|
| | WL-2406(K052785) | WL-2407(K091757) | WL-2406 | |
| Net charge | | 0 | 0 | 0 |
| Max. phase charge | | 13 uc | 20.8 uc | 13 uc |
| Max. current Density | | 0.0246 mA/cm² | 0.04992 mA/cm² | 0.04875 mA/cm² |
| Max. Average | 500 Ω | 50 mA | 80 mA | 50 mA |
| current | 2K Ω | 22.5 mA | 30 mA | 22.5 mA |
| (RMSA) | 10 Ω | 7.5 mA | 10 mA | 7.5 mA |
| Max. Power Density | | 0.00156 Watts/ cm² | 0.00200 Watts/ cm² | 0.001219 Watts/ cm² |
| Burst Mode | | Yes | Yes | Yes |
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# 9. Comparison of Unit Characteristics & Output Specification
| | | Predicate Device | | New Device |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|------------------------------------------|---------------------------------------|------------------------------------------|
| | | WL-2406 | WL-2407 | WL-2406 OTC Patch |
| Mode or Program Name | | | | |
| | Waveform (e.g., pulsed monophasic, biphasic) | Biphasic | Biphasic | Biphasic |
| | Shape (e.g., rectangular, spike, rectified sinusoidal) | Rectangular | Rectangular | Rectangular |
| | Maximum Output Voltage (volts) (+/- 20 %) | 25V @500Ω<br>45V @2KΩ<br>75V @10KΩ | 40V @500Ω<br>60V @2KΩ<br>100V @10KΩ | 25V @500Ω<br>45V @2KΩ<br>75V @10KΩ |
| | Maximum Output Current (mA) (+/- 20 %) | 50mA @500Ω<br>22.5mA @2KΩ<br>7.5mA @10KΩ | 80mA @500Ω<br>30mA @2KΩ<br>10mA @10KΩ | 50mA @500Ω<br>22.5mA @2KΩ<br>7.5mA @10KΩ |
| | Duration of primary phase (usec) | 260 max | 260 max | 260 max |
| | Pulse Duration (usec) | 8700 max | 650 max | 8700 max |
| | Frequency (Hz) [or Rate (pps)] | 120 max | 60 max | 120 max |
| For multiphasic waveforms only: | Symmetrical phases?<br>Phase Duration (include units),(Stage range, if applicable),(both phases, if asymmetrical) | Yes | Yes | Yes |
| | | Not applicable | Not applicable | Not applicable |
| | 510(K) Number | K052785 | K091757 | Unknown |
| | Device Name and Model | WL-2406 | WL-2407 | WL-2406 OTC Patch |
| | Manufacturer | Well-Life | Well-Life | Well-Life |
| | Power Source(s) | 1.5Vx2 (AAA Size) | 1.5Vx3 (AAA Size) | 1.5Vx2 (AAA Size) |
| | - Method of Line current Isolation | Type BF | Type BF | Type BF |
| | - Patient Leakage Current | --- | --- | --- |
| | - Normal condition (uA) | Under 0.1 | Under 0.1 | Under 0.1 |
| | - single Fault condition (uA) | Under 0.5 | Under 0.5 | Under 0.5 |
| | Average DC current through electrodes when device is on but no pulses are being applied (uA) | Not applicable | Not applicable | Not applicable |
| | Number of Output Modes | 8 | 8 | 8 |
| Number of Output Channels: | Synchronous or Alternating?<br>Method of Channel Isolation | Synchronous<br>Output Coil | Synchronous<br>Output Coil | Synchronous<br>Output Coil |
| | Regulated Current or Regulated Voltage? | Voltage | Voltage | Voltage |
| | Software/Firmware/Microprocessor control? | Yes | Yes | Yes |
| | Automatic Overload Trip? | No | No | No |
| | Automatic No-Load Trip? | Yes | Yes | Yes |
| | Automatic Shut Off? | Yes | Yes | Yes |
| | User Override control? | No | No | No |
| | On/Off Status? | Yes | Yes | Yes |
| | Indicator Display: | Low Battery?<br>Voltage/Current Level? | Yes<br>Yes<br>Yes | Yes<br>Yes<br>Yes |
| | Timer Range (Minutes) | 10-60 | 5-60 | 10-60 |
| | Compliance with Voluntary Standards? | IEC 60601-2-10 | IEC 60601-2-10 | IEC 60601-2-10 |
| | Compliance with 21 CFR 898? | Yes | Yes | Yes |
| Weight (g) including battery<br>Dimensions (mm.) [W x H x D] | | 51.6<br>68×60×17.5 | 125.5<br>90×50.8×12.7 | 51.6<br>68×60×17.5 |
| | Housing Materials and construction | ABS | ABS | ABS |
| | Pulse per burst | Same for each program | Same for each program | Same for each program |
| Burst per second | | Same for each program | Same for each program | Same for each program |
| Bust duration | | Same for each program | Same for each program | Same for each program |
| | Duty Cycle | Same for each program | Same for each program | Same for each program |
| Method of achieving zero net charge for net | | Biphasic symmetric | Biphasic symmetric | Biphasic symmetric |
| | | wave for each | wave for each | wave for each |
| | charge/pulse | | | |
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## 10. Summary for the technology comparison.
Basically the OTC Patch, Model WL-2406 has the similar technological characteristics with the predicate device in the product design, material, energy source type, main program mode and the main output waveform ... etc. There exists some difference in the detailed output parameters (mainly in the pulse duration and electrode sizes). Through the detailed calculation comparison of stimulation output energy for each operation modelin particular the output current density and power density), we found the output level in each operation mode for our OTC Patch, model WL-2406 and predicate device are very close and within the acceptable range as specified in FDA guidance. So we believe the difference in detailed output parameters does not affect the determination of substantial equivalence.
## 11. Conclusions
The OTC Patch, Model: WL-2406 have the same intended use and the similar technological characteristics as the cleared devices. Moreover, verification and validation tests contained in this submission 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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#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 28, 2014
Well-Life Healthcare Limited c/o Jenny Hsieh 1FL., No.16, Lane 454, Jungjeng Rd. Yunghe City, Taipei County 234, Taiwan, R.O.C.
Re: K133723
Trade/Device Name: Well-Life OTC Patch, model: WL-2406 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: Class II Product Code: NUH Dated: December 4, 2013 Received: December 6, 2013
Dear Jenny 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, 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 complics 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
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Page 2 - Jenny Hsieh
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Carlos L. Pena -S
Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
## 510(k) Number (if known) K133723
Device Name Well-Life OTC Patch, model: WL-2406
### Indications for Use (Describe)
The OTC Patch, Model WL-2406, is intended for temporary relice of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities
Type of Use (Select one or both, as applicable)
J Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
## FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
# Carlos L. Pena -
FORM FDA 3881 (1/14)
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