(125 days)
Not Found
No
The description mentions a microprocessor-controlled device with adjustable pulse intensity, which is standard for TENS devices and does not indicate the use of AI or ML. There are no mentions of AI, DNN, or ML, nor descriptions of training or test sets typically associated with AI/ML development.
Yes.
The device is a Transcutaneous Electrical Nerve Stimulator (TENS) intended for temporary relief of pain, which is an explicit therapeutic purpose.
No
Explanation: The device is described as a Transcutaneous Electrical Nerve Stimulator (TENS) intended for temporary pain relief. It delivers electrical pulses to stimulate nerves, but it does not analyze or interpret physiological data to diagnose a condition. Its purpose is therapeutic (pain relief), not diagnostic.
No
The device description explicitly states it is a Transcutaneous Electrical Nerve Stimulator (TENS) that delivers electrical pulses through electrode pads, indicating it is a hardware device with embedded software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the temporary relief of pain associated with sore and aching muscles. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is described as a Transcutaneous Electrical Nerve Stimulator (TENS). TENS devices deliver electrical pulses to the skin for pain relief, which is a physical therapy modality, not an in vitro diagnostic test.
- Lack of Diagnostic Activity: There is no mention of the device analyzing samples (like blood, urine, or tissue) or providing information about a patient's health status or disease. IVD devices are designed to perform tests on samples to diagnose, monitor, or screen for conditions.
Therefore, this device falls under the category of a therapeutic medical device, specifically a TENS unit, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
Product codes (comma separated list FDA assigned to the subject device)
NUH
Device Description
The subject device is a Transcutaneous Electrical Nerve Stimulator (TENS), intended for the over-thecounter use to temporarily relieve pain in different body areas. The subject device, which is compact, portable, and microprocessor-controlled, delivers a gentle electrical pulse to the user's skin through the electrode pads for pain relief. According to the need of users, the pulse intensity can be adjustable on the front control panel of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back, arm, and leg
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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)
The subject device does not conduct, nor rely upon, clinical tests to determine substantial equivalence. Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility.
- (a) IEC 60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance".
- (b) IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral standard: Electromagnetic Compatibility - Requirements and Tests".
- (c) IEC 60601-2-10 "Medical electrical equipment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators".
In addition to the compliance of voluntary standards, the verification of software used in the subject device has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The biocompatible electrodes, as the accessory of the subject device, also meet the requirement of safety.
Results: The tests performed and the comparison of technical characteristics, specifications, and intended use demonstrate the subject device is substantially equivalent to the predicate device. Therefore, the subject device is as safe and effective as the foregoing identified OTC predicate devices that have been legally marketed in the United States.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three overlapping profiles of human faces, creating a sense of community and connection. The overall design is simple, clean, and professional.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 17, 2014
Shenzhen Jingkehui Electronic Co. LTD c/o Bill Quanqin Dai, Ph.D. Application Correspondent 513 Piazza Drive, Unit B Mountain View, CA, 94043
Re: 510(k) Number: K141260 Trade/Device Name: Electronic Pulse Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Neurology Regulatory Class: Class II Product Code: NUH Dated: Aug 16th 2014 Received: Aug 20th 2014
Dear Dr. Dai.
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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.
Felipe Aguel -S
Carlos Pena, Ph.D. for
Director- Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141260
Device Name
Electronic Pulse Stimulator
Indications for Use (Describe)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
Type of Use (Select one or both, as applicable)
- 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) (Signature)
Date: 2014.09.17 15:39:53 -04'00'
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3
510(k) Summary
This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
1. Submitter's Information
Submitter: Shenzhen Jingkehui Electronic Co., Ltd. Address: 5F, Building 12, Hengmingzhu Industrial Park, Xiangxing Road, Shajing, Baoan District, Shenzhen, China Contact Person: Pu Jiang Tel: +86-755-29970323 Fax: +86-755-23493443 Email: bill@JKHhealth.com Date of Preparation: 05/12/2014
2. Subject Device
Trade/Device Name: Electronic Pulse Stimulator Common Name: Transcutaneous electrical nerve stimulator (TENS) Regulation Description: Transcutaneous electrical nerve stimulator for pain relief Definition: Temporary relief of pain due to sore/aching muscles Regulation Medical Specialty: Neurology Review Panel: Neurology Product Code: NUH Regulation Number: 21 CFR 882.5890 Device Class: II Use: Over-The-Counter
3. Predicate device
Predicate Device: Electronic Pulse Stimulator 510(k) Number: K131921 Use: Over-The-Counter Submitter: Shenzhen Jingkehui Electronic Co., Ltd.
Predicate Device: IQ Technologies 510(k) Number: K131290 Use: Over-The-Counter Submitter: IO Technologies Inc.
4. Description of Subject Device
The subject device is a Transcutaneous Electrical Nerve Stimulator (TENS), intended for the over-thecounter use to temporarily relieve pain in different body areas. The subject device, which is compact, portable, and microprocessor-controlled, delivers a gentle electrical pulse to the user's skin through the electrode pads for pain relief. According to the need of users, the pulse intensity can be adjustable on the front control panel of the device.
5. Intended Use of Subject Device
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
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6. Summary of Substantial Equivalence
The following table summarizes the comparison between the subject device and predicate devices, indicating the technical characteristics of the subject device are substantially equivalent to those of the predicate devices.
| Parameter | Subject Device | Subject Device | Predicate Device | Predicate Device |
|---|---|---|---|---|
| 510(k) Number | K141260 | K141260 | K131921 | K131290 |
| Device Name/Model | Electronic | |||
| Pulse | ||||
| Stimulator/PL-029BL | Electronic | |||
| Pulse | ||||
| Stimulator/PL-029K | Electronic | |||
| Pulse | ||||
| Stimulator/PL-029 | IQ Technologies | |||
| Maximum output | ||||
| voltage (Volts +/- | ||||
| 20%) at 500Ω | Mode 1: 41.6 | |||
| Mode 2: 66.4 | ||||
| Mode 3: 60.8 | ||||
| Mode 4: 35.2 | ||||
| Mode 5: 32.8 | ||||
| Mode 6: This mode | ||||
| cycles the above | ||||
| modes | ||||
| Mode 7: 75.2 | ||||
| Mode 8: 24.0 | Mode 1: 46.0 | |||
| Mode 2: 59.6 | ||||
| Mode 3: 49.2 | ||||
| Mode 4: 64.8 | ||||
| Mode 5: 37.2 | ||||
| Mode 6: This mode | ||||
| cycles the above | ||||
| modes | ||||
| Mode 7: 71.2 | ||||
| Mode 8: 64.0 | 49.6 | Mode 1: 42 | ||
| Mode 2: 63.2 | ||||
| Mode 3: 64 | ||||
| Mode 4: 34.4 | ||||
| Mode 5: 32 | ||||
| Mode 6: This | ||||
| mode cycles the | ||||
| above modes | ||||
| Maximum output | ||||
| voltage (Volts +/- | ||||
| 20%) at 2ΚΩ | Mode 1: 80.0 | |||
| Mode 2: 100 | ||||
| Mode 3: 83.2 | ||||
| Mode 4: 70.4 | ||||
| Mode 5: 67.2 | ||||
| Mode 6: This mode | ||||
| cycles the above | ||||
| modes | ||||
| Mode 7: 121 | ||||
| Mode 8: 46.4 | Mode 1: 86.4 | |||
| Mode 2: 111 | ||||
| Mode 3: 80 | ||||
| Mode 4: 90.4 | ||||
| Mode 5: 64.8 | ||||
| Mode 6: This mode | ||||
| cycles the above | ||||
| modes | ||||
| Mode 7: 122 | ||||
| Mode 8: 89.6 | 99.2 | Mode 1: 80.8 | ||
| Mode 2: 94.4 | ||||
| Mode 3: 87.2 | ||||
| Mode 4: 68 | ||||
| Mode 5: 64 | ||||
| Mode 6: This | ||||
| mode cycles the | ||||
| above modes | ||||
| Maximum output | ||||
| voltage (Volts +/- | ||||
| 20%) at 10kΩ | Mode 1: 125 | |||
| Mode 2: 128 | ||||
| Mode 3: 84.8 | ||||
| Mode 4: 123 | ||||
| Mode 5: 116 | ||||
| Mode 6: This mode | ||||
| cycles the above | ||||
| modes | ||||
| Mode 7: 134 | ||||
| Mode 8: 85.6 | Mode 1: 116 | |||
| Mode 2: 146 | ||||
| Mode 3: 138 | ||||
| Mode 4: 106 | ||||
| Mode 5: 111 | ||||
| Mode 6: This mode | ||||
| cycles the above | ||||
| modes | ||||
| Mode 7: 136 | ||||
| Mode 8: 96.8 | 114 | Mode 1: 129 | ||
| Mode 2: 129 | ||||
| Mode 3: 96.8 | ||||
| Mode 4: 128 | ||||
| Mode 5: 119 | ||||
| Mode 6: This | ||||
| mode cycles the | ||||
| above modes | ||||
| Maximum output | ||||
| current (mA +/- 20%) | ||||
| at 500Ω | Mode 1: 83.2 | |||
| Mode 2: 132.8 | ||||
| Mode 3: 121.6 | ||||
| Mode 4: 70.4 | ||||
| Mode 5: 65.6 | ||||
| Mode 6: This mode | ||||
| cycles the above | ||||
| modes | Mode 1: 92.0 | |||
| Mode 2: 119.2 | ||||
| Mode 3: 98.4 | ||||
| Mode 4: 129.6 | ||||
| Mode 5: 74.4 | ||||
| Mode 6: This mode | ||||
| cycles the above | ||||
| modes | 18 | Mode 1: 84 | ||
| Mode 2: 126.4 | ||||
| Mode 3: 128 | ||||
| Mode 4: 68.8 | ||||
| Mode 5: 64 | ||||
| Mode 6: This | ||||
| mode cycles the | ||||
| modes | modes | above modes | ||
| Mode 7: 150.4 | Mode 7: 142.4 | |||
| Mode 8: 48.0 | Mode 8: 128.0 | |||
| Maximum output | ||||
| current (mA +/- 20%) | ||||
| at 2ΚΩ | Mode 1: 40.0 | Mode 1: 43.2 | 3.2 | Mode 1: 40.4 |
| Mode 2: 50 | Mode 2: 55.5 | Mode 2: 47.2 | ||
| Mode 3: 41.6 | Mode 3: 40 | Mode 3: 43.6 | ||
| Mode 4: 35.2 | Mode 4: 45.2 | Mode 4: 34 | ||
| Mode 5: 33.6 | Mode 5: 32.4 | Mode 5: 32 | ||
| Mode 6: This mode | ||||
| cycles the above | ||||
| modes | Mode 6: This mode | |||
| cycles the above | ||||
| modes | Mode 6: This | |||
| mode cycles the | ||||
| above modes | ||||
| Mode 7: 60.5 | Mode 7: 61 | |||
| Mode 8: 23.2 | Mode 8: 44.8 | |||
| Maximum output | ||||
| current (mA +/- 20%) | ||||
| at 10KΩ | Mode 1: 12.5 | Mode 1: 11.6 | 0.6 | Mode 1: 12.9 |
| Mode 2: 12.8 | Mode 2: 14.6 | Mode 2: 12.9 | ||
| Mode 3: 8.5 | Mode 3: 13.8 | Mode 3: 9.7 | ||
| Mode 4: 12.3 | Mode 4: 10.6 | Mode 4: 12.8 | ||
| Mode 5: 11.6 | Mode 5: 11.1 | Mode 5: 11.9 | ||
| Mode 6: This mode | ||||
| cycles the above | ||||
| modes | Mode 6: This mode | |||
| cycles the above | ||||
| modes | Mode 6: This | |||
| mode cycles the | ||||
| above modes | ||||
| Mode 7: 13.4 | Mode 7: 13.6 | |||
| Mode 8: 8.6 | Mode 8: 9.7 | |||
| Pulse Width (μSec) | 100 | 50~100 | 50~140 | 100 |
| Pulse period (mSec) | 6.1~824 | 12~832 | 40 | 10~840 |
| Frequency (Hz) | Mode 1: 69.4 | Mode 1: 54.3 | 86 | Mode 1: 69.4 |
| Mode 2: 12.8~53.2 | Mode 2: 35.7 | Mode 2: 12.3~54.3 | ||
| Mode 3: 1.2 | Mode 3: 62.5 | Mode 3: 1.2 | ||
| Mode 4: 96.2 | Mode 4: 6.7 | Mode 4: 100 | ||
| Mode 5: 96.2 | Mode 5: 83.3 | Mode 5: 100 | ||
| Mode 6: This mode | ||||
| cycles the above | ||||
| modes | Mode 6: This mode | |||
| cycles the above | ||||
| modes | Mode 6: This | |||
| mode cycles the | ||||
| above modes | ||||
| Mode 7: 19.2 | Mode 7: 19.8 | |||
| Mode 8: 164.4 | Mode 8: 1.2 | |||
| Maximum Phase | ||||
| charge (µC) at 500Ω | Mode 1: 17.3 | Mode 1: 19.9 | 23 | Mode 1: 18.1 |
| Mode 2: 24.4 | Mode 2: 6.0 | Mode 2: 27.3 | ||
| Mode 3: 24.3 | Mode 3: 4.9 | Mode 3: 25.6 | ||
| Mode 4: 14.6 | Mode 4: 6.5 | Mode 4: 14.9 | ||
| Mode 5: 12.6 | Mode 5: 3.7 | Mode 5: 12.8 | ||
| Mode 6: This mode | ||||
| cycles the above | ||||
| modes | Mode 6: This mode | |||
| cycles the above | ||||
| modes | Mode 6: This | |||
| mode cycles the | ||||
| above modes | ||||
| Mode 7: 31.3 | Mode 7: 33.0 | |||
| Mode 8: 9.2 | Mode 8: 25.6 | |||
| Maximum current | ||||
| density (mA/cm2) | Mode 1: 3.33 | Mode 1: 5.75 | 1.4 | Mode 1: 3.36 |
5
6
| 500Ω | Mode 3: 4.86
Mode 4: 2.82
Mode 5: 2.62
Mode 6: This mode cycles the above modes
Mode 7: 6.02
Mode 8: 1.92 | Mode 3: 6.15
Mode 4: 8.10
Mode 5: 4.65
Mode 6: This mode cycles the above modes
Mode 7: 8.90
Mode 8: 8.00 | 0.23 | Mode 3: 5.12
Mode 4: 2.75
Mode 5: 2.56
Mode 6: This mode cycles the above modes |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|------|-------------------------------------------------------------------------------------------------------------------------------|
| Maximum average power density (mW/cm²) at 500Ω | Mode 1: 2.00
Mode 2: 0.833.453.75
Mode 3: 0.07
Mode 4: 1.98
Mode 5: 1.59
Mode 6: This mode cycles the above modes
Mode 7: 1.81
Mode 8: 1.45 | Mode 1: 3.10
Mode 2: 0.79
Mode 3: 0.95
Mode 4: 0.18
Mode 5: 0.72
Mode 6: This mode cycles the above modes
Mode 7: 2.91
Mode 8: 0.12 | | Mode 1: 2.11
Mode 2: 0.85
Mode 3: 0.08
Mode 4: 2.05
Mode 5: 1.64
Mode 6: This mode cycles the above modes |
7. Substantial Equivalence
The operational principle of the above predicate device is to generate small pulses of electrical current and deliver the pulses to the user's skin through adhesive electrode pads such that the underlying nerves are activated and the pain associated with sore and aching muscles is temporarily relieved.
Identically, the subject device generates small pulses of electrical current and delivers the pulses to the user's skin through adhesive electrode pads such that the underlying nerves are activated and the pain associated with sore and aching muscles is temporarily relieved.
The comparison between the subject device and predicate devices demonstrates the technical characteristics, specifications, and intended use of the subject device are substantially equivalent to those of the predicate devices.
The differences, such the output voltage and current, between the subject device and the predicate devices are insignificant in terms of safety or effectiveness. The verification and validation tests, such as IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-10, further demonstrate these differences maintain the same safety and effectiveness as those of the 510(k) cleared predicate devices. In other words, these differences do not affect the intended use or alter the fundamental technology of the device. There are no new safety or effectiveness issues concerning the subject device, which offers substantially equivalent technical specifications, features, intended use, and effective results as the predicate devices.
Concerns of the safe and proper use of the biocompatible electrode pads have been fully addressed by making the use conscious of the proper placement of the electrode pads and appropriate operations of the device through details in the labeling.
8. Non-Clinical Tests Performed
The subject device does not conduct, nor rely upon, clinical tests to determine substantial equivalence. Non-clinical tests were performed on the subject device in order to validate the design and to assure
7
conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility.
- (a) IEC 60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance".
- (b) IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral standard: Electromagnetic Compatibility - Requirements and Tests".
- (c) IEC 60601-2-10 "Medical electrical equipment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators".
In addition to the compliance of voluntary standards, the verification of software used in the subject device has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The biocompatible electrodes, as the accessory of the subject device, also meet the requirement of safety.
9. Conclusion
The tests performed and the comparison of technical characteristics, specifications, and intended use demonstrate the subject device is substantially equivalent to the predicate device. Therefore, the subject device is as safe and effective as the foregoing identified OTC predicate devices that have been legally marketed in the United States.