(146 days)
No
The document describes a standard TENS/PMS device with pre-set programs and manual controls. There is no mention of adaptive algorithms, learning capabilities, or any terms associated with AI/ML.
Yes
The device is intended for pain relief and muscle stimulation, which are therapeutic uses.
No
Explanation: The device is described as a Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS) device, intended for temporary pain relief and muscle stimulation, not for diagnosing conditions.
No
The device description clearly outlines hardware components such as a battery, LCD display, keys, output sockets, USB port, electrode pads, and cables, indicating it is a physical device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for temporary relief of pain and to stimulate healthy muscles. These are therapeutic applications, not diagnostic ones.
- Device Description: The description details a device that delivers electrical pulses to the body through electrodes. This is consistent with a TENS/PMS device, which is used for physical stimulation and pain relief, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device's function is entirely external and therapeutic.
N/A
Intended Use / Indications for Use
Transcutaneous Electrical Nerve Stimulation (Program 2, 3, 4, 6, 8, 9):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
Powered Muscle Stimulation (Program 1, 5, 7, 10, 11, 12):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Product codes (comma separated list FDA assigned to the subject device)
NUH, NGX
Device Description
MHD TENS is portable and DC 3.7V battery powered device, offering both transcutaneous electrical nerve stimulator (TENS) and powered muscle stimulator (PMS) qualities in one device.
MHD TENS has 12 operation programs, which can give certain electrical pulses through electrode adhesive pads to the suggested area of the body where the electrodes are placed.
The electronic stimulatory module has the operating elements of Switch, LCD Display screen, Screen lock key, Intensity Modification keys, Timing key, Output sockets, and USB port for battery charging.
The LCD screen can display treatment remaining time, battery power, selected program, output port, current intensity, selected intensity and lock state.
The device is equipped with accessories of electrode pads, electrode cables, a screen stylus, a battery charger and a USB cable. The electrode cables are used to connect the pads to the device; the USB cable is used to connect the AC charger and the built-in lithium battery. The screen stylus is used to touch and operate the display screen. All accessories, including the USB cable, electrode pads, electrode cables, and the charger can only be replaced. The electrodes are interchangeable. The application area of electrode pads must be larger than 12cm². The electrode pads are provided by Shenzhen Mailuokang Technology Co., Ltd. with 510(k) cleared Number K152815.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, waist, back, upper extremities (arm), and lower extremities (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): 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.
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
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June 19, 2019
MingHuangDa Electronic Co., Ltd % Doris Dong Manager Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road Songjiang Area Shanghai, 201613 CN
Re: K190115
Trade/Device Name: MHD TENS Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: March 13, 2019 Received: March 21, 2019
Dear Doris Dong:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Vivek Pinto Assistant Director, Acute Injury Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190115
Device Name MHD TENS
Indications for Use (Describe)
Transcutaneous Electrical Nerve Stimulation (Program 2, 3, 4, 6, 8, 9):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
Powered Muscle Stimulation (Program 1, 5, 7, 10, 11, 12):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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Floor6, Building A, Taixinglong Industrial Park, Hezhou Village, Xixiang Town, Baoan District, Shenzhen City, China.
510(k) Summary
[As required by 21 CFR 807.92]
1. Submission Information:
| 510(k) Number: | K190115 |
|---|---|
| Date: | June 18, 2019 |
| Type of 510(k) Submission: | Traditional |
| Basis for 510(k) Submission: | New device |
| Submitter/Manufacturer: | MingHuangDa Electronic Co.,Ltd. |
| Floor6, Building A, Taixinglong Industrial Park, Hezhou Village, Xixiang | |
| Town, Baoan District, Shenzhen City, China. | |
| Contact: | Doris Dong |
| [Consultant, from Shanghai CV Technology Co., Ltd.] | |
| Add: Room 903, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 China | |
| E-mail: doris_d@126.com | |
| Tel: 86 21-31261348 / Fax: 86 21-57712250 | |
| 2. Device Description: | |
| Proprietary Name: | MHD TENS |
| Common Name: | TENS & PMS |
| Classification Name: | Stimulator, nerve, transcutaneous, over-the-counter, |
| Stimulator, muscle, powered, for muscle conditioning | |
| Regulation Number: | 882.5890, 890.5850 |
| Product Code: | NUH, NGX |
| Device Class: | II |
| Review Panel: | Neurology & Physical Medicine |
| Device Description: | MHD TENS is portable and DC 3.7V battery powered device, offering both |
| transcutaneous electrical nerve stimulator (TENS) and powered muscle | |
| stimulator (PMS) qualities in one device. | |
| MHD TENS has 12 operation programs, which can give certain electrical | |
| pulses through electrode adhesive pads to the suggested area of the body | |
| where the electrodes are placed. | |
| The electronic stimulatory module has the operating elements of Switch, | |
| LCD Display screen, Screen lock key, Intensity Modification keys, Timing | |
| key, Output sockets, and USB port for battery charging. | |
| The LCD screen can display treatment remaining time, battery power, | |
| selected program, output port, current intensity, selected intensity and lock | |
| state. | |
| The device is equipped with accessories of electrode pads, electrode cables, | |
| a screen stylus, a battery charger and a USB cable. The electrode cables are | |
| used to connect the pads to the device; the USB cable is used to connect the | |
| AC charger and the built-in lithium battery. The screen stylus is used to | |
| touch and operate the display screen. All accessories, including the USB | |
| cable, electrode pads, electrode cables, and the charger can only be replaced |
4
Floor6, Building A, Taixinglong Industrial Park, Hezhou Village, Xixiang Town, Baoan District, Shenzhen City, China. The electrodes are interchangeable. The application area of electrode pads must be larger than 12cm². The electrode pads are provided by Shenzhen Mailuokang Technology Co., Ltd. with 510(k) cleared Number K152815. Indications for use: Transcutaneous Electrical Nerve Stimulation (Program 2, 3, 4, 6, 8, 9): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. Powered Muscle Stimulation (Program 1, 5, 7, 10, 11, 12): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
5
MingHuangDa Electronic Co.,Ltd
Floor6, Building A, Taixinglong Industrial Park, Hezhou Village, Xixiang Town, Baoan District, Shenzhen City, China.
3. Substantial Equivalence to Predicate device:
Detailed comparison data is included in "Section 9 - Substantial Equivalence Discussion" of this 510(k) submission.
| Parameters | New Device | Predicate Device | Same/Different |
|---|---|---|---|
| 1. 510(k) Number: | K190115 | K143268 | |
| 2. Marketing clearance date: | 07/21/2015 | ||
| 3. Device Name | MHD TENS | TENS AND POWERED MUSCLE STIMULATOR | |
| 4. Manufacturer | MingHuangDa Electronic Co.,Ltd | Shenzhen As-Tec Technology Co., Ltd. | |
| 5. Intended use | Transcutaneous Electrical Nerve Stimulation | ||
| (Program 2, 3, 4, 6, 8, 9): | |||
| To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. | |||
| Powered Muscle Stimulation (Program 1, 5, 7, 10, 11, 12): | |||
| It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. | TENS: | ||
| To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. | |||
| PMS: | |||
| It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. | Same | ||
| 6. Type of use | OTC | OTC | Same |
| 7. Power Source(s) |
- Method of Line Current Isolation
- Patient Leakage Current
- Normal Condition (μΑ)
- Single Fault Condition (μΑ) | DC 3.7V lithium battery
Type BF
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