(126 days)
No
The device description focuses on fixed parameters and adjustable intensity, with no mention of adaptive algorithms, learning, or AI/ML terms. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is a Transcutaneous Electrical Nerve Stimulator (TENS) intended for the temporary relief of pain associated with sore and aching muscles, which classifies it as a therapeutic device.
No
The device is described as a Transcutaneous Electrical Nerve Stimulator (TENS) intended for pain relief by applying electrical current to muscles. Its stated purpose is temporary relief of pain and it does not mention any capabilities for diagnosing conditions, only for treating symptoms.
No
The device description explicitly states it consists of a stimulus generator and electrodes, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Mini Patch is a transcutaneous electrical nerve stimulator. It works by applying electrical current to the skin for pain relief. This is an external application of energy to the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is for temporary relief of pain associated with sore and aching muscles. This is a therapeutic application, not a diagnostic one.
Therefore, the Mini Patch, models WL-2301A & WL-2301B, are therapeutic devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The Mini Patch, model: WL-2301A & WL-2301B Transcutaneous Electrical Nerve Stimulators are intended for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
Product codes
NUH
Device Description
The Mini Patch, models WL-2301B are transcutaneous electrical nerve stimulator used for pain relief by applying an electrical current to electrodes, which are attached on the skin. The output and waveform characteristic is fixed for every model, only the intensity is adjustable.
The Mini Patch, models WL-2301A & WL-2301AB, 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 Patch 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-2302(K020020). Every model of Mini-TENS has its individual stimulation operation cycle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower extremities (arm and/or leg)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
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.(b)
Classification. Class II (performance standards).
0
510(K) Summary
SEP 7 2012
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: K121353
Submitter's Identifications: 1.
Well Life Healthcare Limited 1F. No. 16. Lane 454. Jungjeng Road. Yunghe City, Taipei County 234, Taiwan, ROC
Contact: Jenny Hsieh Telephone: + 886 2 2928 2112
Date of Summary Preparation: August 17, 2012
- Name of the Device:
Trade/Device Name: Mini Patch, model : WL-2301A & WL-2301B. Regulation Number: 21 CFR 882.5890 Regulation Name: Stimulator, Nerve, Transcutaneous For Pain Relief. Requlatory Class: II -Product Code: NUH
- Information of the 510(k) Cleared Device (Predicate Device): ന് Well-Life OTC TENS for Arm & Leg Pain Relief. (K091757)
- Device Description:
The Mini Patch, models WL-2301B are transcutaneous electrical nerve stimulator used for pain relief by applying an electrical current to electrodes, which are attached on the skin. The output and waveform characteristic is fixed for every model, only the intensity is adjustable.
The Mini Patch, models WL-2301A & WL-2301AB, 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 Patch 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-2302(K020020). Every model of Mini-TENS has its individual stimulation operation cycle.
1
5. Intended Use:
The Mini Patch, model: WL-2301A & WL-2301B Transcutaneous Electrical Nerve Stimulators are intended for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are ଚ. as follows:
Compliance to applicable voluntary standards includes ANSI/AAMI, NS4-1985, 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.
7. Comparison of Significant device features
| Comparison
| Features | Models to be Compared | |
|---|---|---|
| Model | OTC TENS for Arm & Leg | Mini Patch |
| 510(K) No. | WL-2407 | WL-2301A & WL-2301B |
| Prescription or | ||
| OTC | K091757 | K121353 |
| Indication for use | OTC | Same |
| FDA product code | intended for temporary relief of pain | |
| associated with sore and aching | ||
| muscles in the upper and lower | ||
| extremities (arm and/or leg) due to | ||
| strain from exercise or normal | ||
| household and work activities | Same | |
| Electrode Used | NUH | Same |
| Manufacturer | K082065, Snap Type self adhesive | |
| electrode (5 X 5 cm) | K082065, Snap Type self adhesive | |
| electrode (2.925 x 5.6 cm) | ||
| Well-Life | Same |
2
8. Comparison of Unit Characteristics & Output Specification
| Parameter | Predicate Device | New Device | ||
|---|---|---|---|---|
| 510(K) Number | K091757 | K121353 | K121353 | |
| Device Name and Model | WL-2407 | WL-2301A | WL-2301B | |
| Manufacturer | Well-Life | Same | Same | |
| Power Source(s) | 1.5Vx3 | |||
| (AAA Size) | 3Vx1 | 3Vx1 | ||
| - Method of Line current Isolation | Type BF | Same | Same | |
| - Patient Leakage Current | --- | --- | --- | |
| - Normal condition (uA) | Under 0.1 | Same | Same | |
| - single Fault condition (uA) | Under 0.5 | Same | Same | |
| Average DC current through electrodes when | ||||
| device is on but no pulses are being applied | ||||
| (UA) | Not applicable | Same | Same | |
| Number of Output Modes | 8 | 3 | 3 | |
| Number of Output | ||||
| Channels: | Synchronous or | |||
| Alternating? | Synchronous | Same | Same | |
| Method of Channel | ||||
| Isolation | Output Coil | Same | Same | |
| Regulated Current or Regulated Voltage? | Voltage | Same | Same | |
| Software/Firmware/Microprocessor control? | Yes | Same | Same | |
| Automatic Overload Trip? | No | Same | Same | |
| Automatic No-Load Trip? | Yes | Same | Same | |
| Automatic Shut Off? | Yes | Same | Same | |
| User Override control? | No | Same | Same | |
| Indicator Display: | On/Off Status? | Yes | Same | Same |
| Low Battery? | Yes | Same | Same | |
| Voltage/Current | ||||
| Level? | Yes | Same | Same | |
| Timer Range (Minutes) | 5~60 | 20 | 20 | |
| Compliance with Voluntary Standards? | ANSI/AAMI NS4, | |||
| IEC 60601-1 & | ||||
| IEC 60601-1-2. | Same | Same | ||
| Compliance with 21 CFR 898? | Yes | Same | Same | |
| Weight (g) | 43 | 20 | 20 | |
| Dimensions (mm.) | ||||
| [W x H x D] | 90×52.5×19.4 | 59×30×12.15 | 60.2×31.9×14.4 | |
| Housing Materials and construction | ABS | Same | Same |
15121353
——————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
| Parameter | Predicate Device | New Device |
|---|---|---|
| Mode or Program Name | WL-2407 | WL-2301A WL-2301B |
| Waveform (e.g., pulsed monophasic, biphasic) | Biphasic | Same Same |
| Shape (e.g., rectangular, spike, rectified sinusoidal) | Rectangular (with deformation on the top of each pulse) | Same Same |
| Maximum Output Voltage (volts) (+/- 20 %) | 40V | |
| @500Ω | ||
| 62V | ||
| @2kΩ | ||
| 104V | ||
| @10kΩ | 30V | |
| @500Ω | ||
| 50V | ||
| @2kΩ | ||
| 80V | ||
| @10kΩ 30V | ||
| @500Ω | ||
| 50V | ||
| @2kΩ | ||
| 80V | ||
| @10kΩ | ||
| Maximum Output Current (specify units) (+/- 20 %) | 80mA | |
| @500Ω | ||
| 31mA | ||
| @2kΩ | ||
| 10.4mA | ||
| @10kΩ | 60mA | |
| @500Ω | ||
| 25mA | ||
| @2kΩ | ||
| 8.0mA | ||
| @10kΩ 60mA | ||
| @500Ω | ||
| 25mA | ||
| @2kΩ | ||
| 8.0mA | ||
| @10kΩ | ||
| Duration of primary (desplarizing) phase (usec) | 260 Max | 250 Max 250 Max |
| Pulse Duration (usec) | 500.26 ms/Max. | 33.58 ms/Max. 33.58 ms/Max. |
| Frequency (Hz) [or Rate (pps)] | 60 Max | 60 Max 60 Max |
| For | ||
| multiphasic | ||
| waveforms | ||
| only: | Symmetrical phases? | |
| Phase Duration (include units), (Stage range, if applicable), (both phases, if asymmetrical) | No | |
| Not applicable Same | ||
| Same Same | ||
| Same |
3
9. Significant output characteristics comparison table:
| Comparison feature | Model | Remarks | |
|---|---|---|---|
| Net charge | WL-2407 | WL-2301/2301B | Note 1 |
| Max. phase charge | 20.8 uc | 15uc | |
| Max. current Density | 0.050 mA/cm² | 0.055 mA/cm² | |
| Max. Average | |||
| current | |||
| (RMSA) | 500 Ω | 38.43mA | 29.394 mA |
| 2K Ω | 14.892mA | 12.248 mA | |
| 10 Ω | 4.996mA | 3.9192 mA | |
| Max. Power Density | 0.0020Watts/ cm² | 0.0017Watts/ cm² | |
| Burst Mode | No | 6Sec/On & 1Sec/Off |
Note: Net Charge is Zero for the symmetrical stimulation biphasic wave
10. Conclusions
The Well-Life Mini Patch, model: WL-2301A & WL-2301B Transcutaneous Electrical Nerve Stimulators has the same intended use and the similar technological characteristics as the cleared device- Well-Life OTC TENS for Arm & Leg Pain Relief. (K091757) . 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.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 7 2012
Well Life Healthcare, Ltd % Ms. Jenny Hsieh 1F1, No.16, Lane 454, Jungjeng Rd. Yunghe City, Taipei County Taiwan, R.O.C.
Re: K121353
Trade/Device Name: Mini Patch, Model WL-2301A & WL-2301B Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: II Product Code: NUH Dated: August 17, 2012 Received: August 21, 2012
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, 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 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
5
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/ReportalProblem/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/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
6
Indications For Use
510(k) Number (if known): K121353
Device Name: Mini Patch, model : WL-2301A & WL-2301B
Indications For Use:
The Mini Patch, model: WL-2301A & WL-2301B Transcutaneous Electrical Nerve Stimulators are intended for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Kunz
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K121353