(90 days)
Not Found
No
The summary describes a standard TENS/EMS device with pre-set programs and manual controls. There is no mention of adaptive algorithms, learning capabilities, or any technology that would typically be associated with AI or ML. The performance studies focus on safety standards, not AI/ML performance metrics.
Yes.
The device is intended for "temporary relief of pain associated with sore and aching muscles" and "to stimulate healthy muscles in order to improve and facilitate muscle performance," which are direct therapeutic benefits.
No
The device is described as a TENS and EMS stimulator used for temporary pain relief and muscle stimulation, not for diagnosing conditions.
No
The device description clearly states it is a portable, battery-powered device with physical components like an LCD display, keys, output sockets, and a USB port. It also includes accessories like electrode pads and cables. This indicates it is a hardware 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:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a TENS and EMS stimulator. It applies electrical pulses to the body's surface to stimulate nerves for pain relief or muscles for performance improvement. It does not analyze any biological samples.
- Intended Use: The intended use clearly states it's for temporary pain relief and muscle stimulation by applying current to the body. This is an external application, not an in vitro analysis.
Therefore, this device falls under the category of medical devices that are applied externally to the body, not IVDs.
N/A
Intended Use / Indications for Use
Transcutaneous Electrical Nerve Stimulation (Program 3,4,6,7,8,9,16,17,19,20,21,22,23,24,28,29,34,36): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Electrical Muscle Stimulation (Program 1,2,5,10,11,12,13,14,15,18,25,26,27,30,31,32,33,35): 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
TENS & EMS Stimulator (Model:MHD-1083) is portable and DC 3.7V battery powered device, offering both transcutaneous electrical nerve stimulator (TENS) and electrical muscle stimulation (EMS) qualities in one device.
TENS & EMS Stimulator has 36 operation programs, which can give certain electrical pulses through electrode adhesive pads to the suggested area of the body where the electrodes are placed. And the TENS (Program 3,4,6,7,8,9,16,17,19,20,21,22,23,24,28,29,34,36) to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Electrical Muscle Stimulation (EMS) (Program 1,2,5,10,11,12,13,14,15,18,25,26,27,30,31,32,33,35) to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
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 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. All accessories, including the USB cable, electrode pads, electrode cables, and the charger can only be replaced by the specialized person. Please ask the retailer to replace it.
The electrodes are interchangeable. The application area of electrode pads must be larger than 10cm². The electrode pads are provided by Dong Guan Ou Kang Electronics CO., LTD. with 510(k) cleared Number K181234.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back, back of the neck, arm, leg, and foot
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 new device has passed testing according to the safety standards:
- ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
- ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021]Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests [Including Amendment 1 (2021)]
- IEC 60601-2-10 Edition 2.1 2016-04, Medical Electrical Equipment -- Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators.
- IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 62133 Edition 2.0 2012-12, IEC 62133 Edition 2.0 2012-12 Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications [Including: Corrigendum 1 (2013)]
The conclusion drawn from the safety testing is that the new device is substantially equivalent to the predicate device. Furthermore, the new device complies with the recognized standards and performs its intended tasks as well as the legally marketed predicate devices.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
September 9, 2024
Shenzhen Minghuangda Electronics Co., Ltd. Guixiang Zhang Official Applicant Floor 6, Building A, Taixinglong Industrial Park, Hezhou Village, Xixiang Town,Baoan District Shenzhen, Guangdong 518100 China
Re: K241678
Trade/Device Name: TENS & EMS Stimulator (MHD-1083) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: May 31, 2024 Received: June 11, 2024
Dear Guixiang Zhang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Doe W. Kumsa -S
for Pamela Scott, MS Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241678
Device Name TENS and EMS Stimulator (MHD-1083)
Indications for Use (Describe)
Transcutaneous Electrical Nerve Stimulation (Program 3,4,6,7,8,9,16,17,19,20,21,22,23,24,28,29,34,36): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Electrical Muscle Stimulation (Program 1,2,5,10,11,12,13,14,15,18,25,26,27,30,31,32,33,35): 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) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
Shenzhen Minghuangda Electronics Co.,LTD Floor6, Building A, Taixinglong Industrial Park, Hezhou Village, Xixiang Town, Baoan District, Shenzhen City, China.
Section 5 510(k) Summary
[As required by 21 CFR 807.92]
1. Submission Information:
| 510(k) Number: | K241678 |
|---|---|
| Date: | May 31,2024 |
| Type of 510(k) Submission: | Traditional |
| Basis for 510(k) Submission: | New device |
| Submitter/Manufacturer: | Shenzhen Minghuangda Electronics 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 602, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 | |
| China | |
| E-mail: doris.d@ceve.org.cn | |
| Tel: 86 21-31261348 / Fax: 86 21-57712250 |
2. Device Description:
| Proprietary Name: | TENS & EMS Stimulator(Model:MHD-1083) |
|---|---|
| Common Name: | TENS & EMS |
| 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: | TENS & EMS Stimulator(Model:MHD-1083) is portable and DC 3.7V |
| battery powered device, offering both transcutaneous electrical nerve | |
| stimulator (TENS) and electrical muscle stimulation (EMS) qualities in one | |
| device. | |
| TENS & EMS Stimulator has 36 operation programs, which can give certain | |
| electrical pulses through electrode adhesive pads to the suggested area of the | |
| body where the electrodes are placed. And the TENS (Program | |
| 3,4,6,7,8,9,16,17,19,20,21,22,23,24,28,29,34,36) to be used for temporary | |
| relief of pain associated with sore and aching muscles in the shoulder, waist, | |
| back, back of the neck, arm, leg, and foot due to strain from exercise or | |
| normal household work activities by applying current to stimulate nerve. | |
| Electrical Muscle Stimulation (EMS) (Program | |
| 1,2,5,10,11,12,13,14,15,18,25,26,27,30,31,32,33,35) to be used to stimulate | |
| healthy muscles in order to improve and facilitate muscle performance. | |
| 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, |
5
| Shenzhen Minghuangda Electronics Co., LTD
| Floor6, Building A, Taixinglong Industrial Park, Hezhou Village, Xixiang Town, Baoan District, Shenzhen City, China. | |
|---|---|
| selected program, output port, current intensity, selected intensity and lock state. | |
| The device is equipped with accessories of electrode pads, electrode cables, 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. All accessories, including the USB cable, electrode pads, electrode cables, and the charger can only be replaced by the specialized person. Please ask the retailer to replace it. | |
| The electrodes are interchangeable. The application area of electrode pads must be larger than 10cm². The electrode pads are provided by Dong Guan Ou Kang Electronics CO., LTD. with 510(k) cleared Number K181234. | |
| Indications for use: | Transcutaneous Electrical Nerve Stimulation (Program 3,4,6,7,8,9,16,17,19,20,21,22,23,24,28,29,34,36): |
| To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve. | |
| Electrical Muscle Stimulation (Program 1,2,5,10,11,12,13,14,15,18,25,26,27,30,31,32,33,35): | |
| It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. |
3. Predicate Device Identification
| Predicate 510(k) Number: | K190115 |
|---|---|
| Marketing Clearance Date: | June 19,2019 |
| Product Name: | MHD TENS |
| Manufacturer: | MingHuangDa Electronic Co.,Ltd |
| Predicate 510(k) Number: | K133929 |
| Marketing Clearance Date: | November 12,2014 |
| Product Name: | Health Expert Electronic Stimulator, Model: AST-300C and AST-300D |
| Manufacturer: | Shenzhen OSTO Technology Company Limited |
6
Shenzhen Minghuangda Electronics Co.,LTD
Floor6, Building A, Taixinglong Industrial Park, Hezhou Village, Xixiang Town, Baoan District, Shenzhen City, China.
4. 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 | Reference Device | Comparison | ||
|---|---|---|---|---|---|---|
| 1. | 510(k) Number: | To be assigned | K190115 | K133929 | -- | |
| 2. | Marketing clearance | |||||
| date: | --- | 06/19/2019 | 11/12/2014 | -- | ||
| 3. | Device Name | TENS & EMS | ||||
| Stimulator | ||||||
| (Model:MHD-1083) | MHD TENS | Health Expert | ||||
| Electronic Stimulator, | ||||||
| Model: AST-300C | ||||||
| and AST-300D | -- | |||||
| 4. | Manufacturer | Shenzhen | ||||
| Minghuangda | ||||||
| Electronics Co.,LTD | MingHuangDa | |||||
| Electronic Co.,Ltd | Shenzhen OSTO | |||||
| Technology Company | ||||||
| Limited | -- | |||||
| 5. | Indications for Use | Transcutaneous | ||||
| Electrical Nerve | ||||||
| Stimulation (Program | ||||||
| 3,4,6,7,8,9,16,17,19,2 | ||||||
| 0,21,22,23,24,28,29,3 | ||||||
| 4,36):To be used for | ||||||
| temporary relief of | ||||||
| pain associated with | ||||||
| sore and aching | ||||||
| muscles in the | ||||||
| shoulder, waist, | ||||||
| back, back of the | ||||||
| neck, arm, leg, and | ||||||
| foot due to strain | ||||||
| from exercise or | ||||||
| normal household | ||||||
| work activities by | ||||||
| applying current to | ||||||
| stimulate nerve. | ||||||
| Electrical | ||||||
| Muscle | ||||||
| Stimulation (Program | ||||||
| 1,2,5,10,11,12,13,14,1 | ||||||
| 5,18,25,26,27,30,31,3 | ||||||
| 2,33,35): | ||||||
| It is intended to be | ||||||
| used to stimulate | ||||||
| healthy muscles in | ||||||
| order to improve and | ||||||
| facilitate muscle | ||||||
| performance. | 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 (Mode 9~25) | |||||
| To be used for | ||||||
| temporary relief of | ||||||
| pain | ||||||
| associated with sore | ||||||
| and | ||||||
| aching muscles in the | ||||||
| shoulder, waist, back, | ||||||
| back of the neck, arm, | ||||||
| leg, and foot due to | ||||||
| strain from exercise or | ||||||
| normal household | ||||||
| work | ||||||
| activities by applying | ||||||
| current to stimulate | ||||||
| nerve. | ||||||
| PMS (Mode 1~8) | ||||||
| It is intended to | ||||||
| stimulate healthy | ||||||
| muscles in order to | ||||||
| improve and facilitate | ||||||
| muscle performance. | Same | |||||
| 6. | Type of use | OTC | OTC | OTC | Same | |
| 7. | Power Source(s) | DC 3.7V lithium | ||||
| battery | DC 3.7V lithium | |||||
| battery | Adaptor Input: 100- | |||||
| 240Vac, 50-60Hz, | ||||||
| 0.1A | ||||||
| Output: 5Vdc, 1A | ||||||
| Unit Input: 5Vdc, 1A | Same | |||||
| - Method of Line | ||||||
| Current Isolation | Type BF | Type BF | Type BF Applied Part | Same | ||
| - Patient Leakage | ||||||
| Current | -- | -- | -- | Same | ||
| - Normal | ||||||
| Condition (μΑ) |