(142 days)
Not Found
No
The description mentions a microprocessor and adjustable pulse intensity, but there is no mention of AI, ML, or any learning or adaptive capabilities. The performance studies focus on electrical safety and software verification, not AI/ML performance.
Yes
The device is described as an Electronic Pulse Stimulator, a Transcutaneous Electrical Nerve Stimulator (TENS), intended for the "temporary relief of pain associated with sore and aching muscles". This clear indication for pain relief qualifies it as a therapeutic device.
No
The device is described as a Transcutaneous Electrical Nerve Stimulator (TENS) used for temporary pain relief. Its intended use and operation do not involve diagnosing any medical condition, but rather providing symptomatic relief.
No
The device description explicitly states it is a "Transcutaneous Electrical Nerve Stimulator (TENS)" that "delivers a gentle electrical pulse through the connecting wires and electrode pads to the user's skin". This indicates a physical hardware component that delivers electrical stimulation, not solely software. The summary also mentions non-clinical tests for electrical safety and electromagnetic compatibility, further supporting the presence of hardware.
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 purpose, 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 a diagnostic test.
- Lack of Diagnostic Activity: There is no mention of the device analyzing biological samples (like blood, urine, or tissue) or performing any kind of test to diagnose a condition.
- Performance Studies: The performance studies focus on electrical safety, electromagnetic compatibility, and software verification, which are relevant to the device's function as a stimulator, not as a diagnostic tool.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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, neck, back, arm, and leg, due to strain from exercise or normal household and work activities.
Product codes
NUH, NGX
Device Description
The Electronic Pulse Stimulator is a Transcutaneous Electrical Nerve Stimulator (TENS), intended for the over-the-counter use to relieve pain in different body areas (waist, back, neck, shoulders, legs, and arms). The proposed Electronic Pulse Stimulator, which is compact, portable, and microprocessorcontrolled, delivers a gentle electrical pulse through the connecting wires and electrode pads to the user's skin 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, neck, back, arm, and 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)
The Electronic Pulse Stimulator does not conduct, nor rely upon, clinical tests to determine substantial equivalence. Non-clinical tests were performed on the proposed 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 Safety -Collateral standard: Electromagnetic Compatibility - Requirements and Tests".
In addition to the compliance of voluntary standards, the verification of software used in the proposed device has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The electrodes, as the accessory of the proposed device, also meet the requirement of safety.
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).
0
K|3|92|
NOV 1 5 2013
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: 3/F, Building 1, B Area, Xifa Industrial Area, Yintian Village, Xixiang Town, Baoan District, Shenzhen. China
Contact Person: Pu Jiang Tel: +86-755-29970323 Fax: +86-755-23493443 Email: jkdz@vip.163.com Date of Preparation: 06/22/2013
2. Proposed Device
Trade Name: Electronic Pulse Stimulator Common Name: Transcutaneous electrical nerve stimulator Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter (OTC) Regulation Description: Transcutaneous electrical nerve stimulator for pain relief Regulation Medical Specialty: Neurology Review Panel: Neurology Product Code: NUH. NGX Regulation Number: 21 CFR 882.5890 Device Class: II Use: Over-The-Counter
3. Predicate device
Predicate Device: Prospera OTC TENS Electronic Pulse Massager 510(k) Number: K122744 Use: Over-The-Counter Submitter: Prospera Corporation
4. Description of Proposed Device
The Electronic Pulse Stimulator is a Transcutaneous Electrical Nerve Stimulator (TENS), intended for the over-the-counter use to relieve pain in different body areas (waist, back, neck, shoulders, legs, and arms). The proposed Electronic Pulse Stimulator, which is compact, portable, and microprocessorcontrolled, delivers a gentle electrical pulse through the connecting wires and electrode pads to the user's skin 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 Statement of Proposed Device
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, neck, back, arm, and leg, due to strain from exercise or normal household and work activities.
6. Substantial Equivalence
The operational principle of the above predicate device is to generate small pulses of electrical current and delivers the pulses to the user's skin through adhesive electrode pads such that the underlying
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nerves are activated and the pain associated with sore and aching muscles is temporarily relieved.
Identically, the proposed 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.
Table 1 below summarizes the comparison between the proposed device and predicate device, indicating the technical characteristics, specifications, and intended use of the proposed device are substantially equivalent to those of the predicate device.
| Proposed Device | Predicate Device | |
|---|---|---|
| 510(k) Number | K131921 | K122744 |
| Device Name | Electronic Pulse Stimulator | Prospera OTC TENS Electronic |
| Pulse Massager | ||
| Intended Use | To be used for temporary relief | |
| of pain associated with sore and | ||
| aching muscles in the shoulder, | ||
| waist, neck, back, arm, and leg, | ||
| due to strain from exercise or | ||
| normal household and work | ||
| activities. | To be used for temporary relief | |
| of pain associated with sore and | ||
| aching muscles in the shoulder, | ||
| waist, back, neck, upper | ||
| extremities (arm), and lower | ||
| extremities (leg) due to strain | ||
| from exercise or normal | ||
| household work activities. | ||
| Power Source | Battery | Battery |
| Number of Output Channels | 2 | 2 |
| Automatic Overload Trip | No | No |
| Automatic No-Load Trip | No | No |
| Automatic Shut Off | Yes | Yes |
| User Override Control | Yes | Yes |
| Indicator | Yes | Yes |
| Waveform | Pulsed | Pulsed |
| Shape | Rectangular | Rectangular |
| Frequency (Hz) | 100 | 100 |
| Maximum charge (µC) at | ||
| 500Ω | 23 | 23 |
| Maximum current density | ||
| (mA/cm²) at 500Ω | 1.4 | 1.4 |
| Compliance with Voluntary | ||
| Standards | IEC60601-1, IEC60601-1-2 | IEC60601-1, IEC60601-1-2 |
| Compliance with 21 CFR | ||
| 898 | Yes | Yes |
Table 1. Comparison between the proposed device and predicate device
7. Non-Clinical Tests Performed
The Electronic Pulse Stimulator does not conduct, nor rely upon, clinical tests to determine substantial equivalence. Non-clinical tests were performed on the proposed 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.
2
- (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 Safety -Collateral standard: Electromagnetic Compatibility - Requirements and Tests".
In addition to the compliance of voluntary standards, the verification of software used in the proposed device has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The electrodes, as the accessory of the proposed device, also meet the requirement of safety.
8. Conclusion
The tests performed and the comparison of technical characteristics, specifications, and intended use demonstrate the proposed device is substantially equivalent to the predicate device. Therefore, the proposed device is as safe, as effective, and performs as well as the foregoing identified OTC predicate devices that have been legally marketed in the United States.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 15, 2013
Shenzhen Jingkehui Electronic Co., Ltd. c/o Qaunqin (Bill) Dai Sunovo, LLC 513 Piazza Drive, Unit B Mountain View, CA 94043
Re: K131921
Trade Name: Electronic Pulse Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH, NGX Dated: October 28, 2013 Received: October 30, 2013
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
4
Page 2 – Qaunqin (Bill) Dai
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,
Joyce M. Whang -S
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K131921
Device Name: Electronic Pulse Stimulator
Indications For Use:
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, neck, back, arm, and leg, due to strain from exercise or normal household and work activities.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Joyce M. Whang -S
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