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.

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 by 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.

AI/ML Overview

This FDA 510(k) summary describes the MHD TENS device and establishes its substantial equivalence to a predicate device (K143268). The provided document does not contain information about a study proving the device meets acceptance criteria in the manner typically expected for AI/ML device performance (e.g., clinical study with human readers, ground truth establishment, etc.). This is because the MHD TENS is a physical electrical stimulation device, not an AI/ML diagnostic or therapeutic system.

Instead, the "acceptance criteria" for a device like the MHD TENS are compliance with recognized electrical safety and performance standards, and comparison with a legally marketed predicate device to demonstrate substantial equivalence. The "study" proving it meets these "acceptance criteria" consists of engineering tests and comparisons to the predicate.

Here's the information extracted and formatted, noting where AI/ML-specific criteria are not applicable:

Acceptance Criteria and Device Performance for MHD TENS

Device Name: MHD TENS
510(k) Number: K190115
Predicate Device: K143268

1. Table of Acceptance Criteria (as indicated by comparison to predicate and safety standards) and Reported Device Performance

Acceptance Criteria (Implied by Predicate Comparison & Standards)	Reported Device Performance (MHD TENS)	Note from document regarding comparison to predicate
Intended Use:
- Temporary pain relief for sore/aching muscles	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.	Same
- Stimulate healthy muscles to improve performance	It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.	Same
Electrical Safety & Performance (via Standards):
Patient Leakage Current (Normal Condition)	< 10µA	Similar (Note 1)
Patient Leakage Current (Single Fault Condition)	< 50µA	Similar (Note 1)
Average DC current (device on, no pulses)	< 0.01µA	Same
Number of Output Channels	2	Same
Method of Channel Isolation	Voltage Isolation	Same
Waveform	Pulsed, symmetric, biphasic	Same
Shape	Rectangular, with interphase interval	Same
Net Charge (per pulse)	0µC @500Ω; Method: Balanced waveform	Same
Maximum Current Density (r.m.s.)	0.142mA/cm² @500Ω (Smallest electrode area 12cm²)	Similar (Note 4)
Maximum Average Power Density	5.54mW/cm² @500Ω (Smallest electrode area 12cm²)	Similar (Note 4)
Compliance with Voluntary Standards	AAMI / ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 62133, IEC 60601-1-11	Same
Compliance with 21 CFR 898	Yes	Same
Other Device Characteristics:
Power Source	DC 3.7V lithium battery, Type BF	Same
Number of Treatment Programs	12	Similar (Note 1)
Output Channel Operation	Alternating	Different (Note 1)
Regulation Type	Regulated current	Different (Note 1)
Software/Firmware/Microprocessor Control	Software	Same
Automatic Overload Trip?	No	Same
Automatic No-Load Trip?	No	Same
Automatic Shut Off?	Yes	Same
User Override Control?	Yes	Same
Indicator Display (On/Off, Low Battery, Voltage/Current Level)	Yes, Yes, Yes	Same
Timer Range	10 ~ 60 minutes, 10 min/step	Same
Max Output Voltage (Examples given: Program 1: 51.2V@500Ω)	Program 1: 51.2V@500Ω, 94V@2kΩ, 156V@10kΩ; Programs 2-12 vary between 48V-152V for different loads, as detailed in the submission.	Similar (Note 2)
Max Output Current (Examples given: Program 1: 102.4mA@500Ω)	Program 1: 102.4mA@500Ω, 47mA@2kΩ, 15.6mA@10kΩ; Programs 2-12 vary between 96mA-156mA for different loads, as detailed in the submission.	Similar (Note 2)
Pulse width (μsec)	Positive phase: 78μs±10%; Negative phase: 78μs±10%; Interphase interval: 70μs±10%	Similar (Note 2)
Max. pulse frequency (Hz)	Programs vary: Program 1: 46Hz; Program 2: 3.3-31Hz; Program 3: 1.1Hz; Program 4: 65Hz; Program 5: 70Hz; Program 6: 2.8-65Hz; Program 7: 45-65Hz; Program 8: 3.1-52.6Hz; Program 9: 1.8-65Hz; Program 10: 1-46Hz; Program 11: 46Hz; Program 12: 1-46Hz. (±10%)	Similar (Note 2)
Maximum Phase Charge	24.3µC @500Ω	Similar (Note 3)
Maximum Average Current	0.852mA@500Ω	Similar (Note 4)
Battery charge	The Lithium battery can be recharged through both AC adaptor and computer USB input. When charging is finished, the LCD will show full cell of battery.	Same
Accessories	Self-adhesive electrodes, electrode wires, Battery charger, USB cable, Screen stylus	Similar (Note 5)

Summary of Notes on Differences:

Note 1 (Patient Leakage Current, Programs, Channel Operation, Regulation Type): Differences in Patient Leakage Current, number of programs, channel operation (alternating vs. synchronous), and regulation type (regulated current vs. voltage control) are considered acceptable because both devices passed AAMI/ANSI ES 60601-1 and/or IEC 60601-2-10 safety standards. The fundamental output technology and similar modes are expected to offer similar treatment effects.
Note 2 (Max Output Voltage, Current, Pulse Width, Frequencies): Differences in these parameters are considered acceptable as calculations and measurements show compliance with AAMI/ANSI ES 60601-2-10. The physiological effectiveness is primarily dependent on delivered charge, and these differences don't raise new safety/effectiveness issues.
Note 3 (Maximum Phase Charge): The proposed device's maximum phase charge (24.3µC @500Ω) is less than the predicate (48µC @500Ω) but falls within the range of cleared devices, including the predicate's predicate (K121719 at 16.8µC @500Ω).
Note 4 (Max Average Current, Current Density, Power Density): While different from the predicate, the proposed device's maximum current density (< 2mA/cm²) and maximum average power density (< 0.25W/cm²) comply with IEC 60601-2-10, thus not raising new safety/effectiveness issues.
Note 5 (Accessories): The proposed device includes a screen stylus and has a touchable display screen with a lock button, which the predicate lacks. These additions do not affect output parameters or operation.

2. Sample size used for the test set and the data provenance

Not applicable in the context of an electrical stimulation device. The "test set" for this type of device refers to the device itself undergoing engineering and safety standard testing, not a dataset of patient cases. The provenance would be the test conditions under which the device was evaluated according to recognized standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. "Ground truth" in the AI/ML sense (e.g., expert-labeled medical images) is not relevant for an electrical stimulation device's regulatory review based on substantial equivalence to a predicate. The "ground truth" for this device's performance relates to its compliance with electrical safety and performance standards (e.g., measured current, voltage, waveform characteristics). These measurements are typically performed by qualified test engineers in accredited labs.

4. Adjudication method for the test set

Not applicable. This concept (e.g., 2+1, 3+1 for clinical consensus) is for interpreting disagreements among expert readers of medical data, which is not relevant here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The MHD TENS is an electrical stimulation device, not an AI-assisted diagnostic or therapeutic system involving human readers interpreting cases.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a standalone hardware device. The concept of "algorithm only" or "human-in-the-loop performance" does not apply.

7. The type of ground truth used

The "ground truth" for the MHD TENS device is based on technical specifications and measurements demonstrating compliance with recognized electrical safety and performance standards (e.g., ANSI AAMI ES60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 62133, IEC 60601-1-11). It also relies on the established safety and effectiveness profile of a legally marketed predicate device (K143268) through a comparison of physical and functional characteristics.

8. The sample size for the training set

Not applicable. This device does not use a training set as it is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. This device does not use a training set.

Summary

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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.

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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, XixiangTown, 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 ChinaE-mail: doris_d@126.comTel: 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 bothtranscutaneous electrical nerve stimulator (TENS) and powered musclestimulator (PMS) qualities in one device.MHD TENS has 12 operation programs, which can give certain electricalpulses through electrode adhesive pads to the suggested area of the bodywhere the electrodes are placed.The electronic stimulatory module has the operating elements of Switch,LCD Display screen, Screen lock key, Intensity Modification keys, Timingkey, 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 lockstate.The device is equipped with accessories of electrode pads, electrode cables,a screen stylus, a battery charger and a USB cable. The electrode cables areused to connect the pads to the device; the USB cable is used to connect theAC charger and the built-in lithium battery. The screen stylus is used totouch and operate the display screen. All accessories, including the USBcable, 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 batteryType BF--< 10μΑ< 50μΑ	DC 3.7V lithium batteryType BF--0.1μΑ0.1μΑ	SameSameSimilar Note 1
8. Average DC current	< 0.01μΑ	< 0.01μΑ	Same

{6}------------------------------------------------

MingHuangDa Electronic Co.,Ltd

Floor6, Building A, Taixinglong Industrial Park, Hezhou Village, Xixiang Town, Baoan District, Shenzhen City, China.
when device is on butno pulses are beingapplied (µA)
9.	Number of treatmentprograms		12	6	SimilarNote 1
10.	Number of Outputchannels:		2	2	Same
	- Synchronous orAlternating?		Alternating	Synchronous	DifferentNote 1
	- Method ofChannel Isolation		VoltageIsolation	VoltageIsolation	Same
11.	Regulated Current orRegulated Voltage?		Regulated current	Voltage control	DifferentNote 1
12.	Software/Firmware/MicroprocessorControl?		Software	Software	Same
13.	Automatic OverloadTrip?		No	No	Same
14.	Automatic No-LoadTrip?		No	No	Same
15.	Automatic Shut Off?		Yes	Yes	Same
16.	User OverrideControl?		Yes	Yes	Same
17.	IndicatorDisplay:	On/OffStatus?	Yes	Yes	Same
		LowBattery?	Yes	Yes	Same
		Voltage/CurrentLevel?	Yes	Yes	Same
18.	Timer Range(minutes)		10 ~ 60 minutes, 10min/step	10 ~ 60 minutes, 10min./step	Same
19.	Compliance withVoluntary Standards?		Yes.AAMI / ANSI ES60601-1, IEC 60601-1-2,IEC 60601-2-10,IEC 62133, IEC60601-1-11	Yes.AAMI / ANSIES60601-1,IEC 60601-1-2, IEC60601-2-10, IEC 62133,IEC 60601-1-11	Same
20.	Compliance with 21CFR 8988?		Yes	Yes	Same
21.	Weight (grams)		110g	170g	Similar
22.	Dimensions (mm) [Wx H x D]		132.865.813.8mm	93509mm	Similar
23.	Housing Materials &Construction		ABS+aluminium alloy	ABS	Similar
24.	Waveform	Pulsed, symmetric, biphasic	Pulsed, symmetric, biphasic	Same
25.	Shape	Rectangular, with interphase interval	Rectangular, with interphase interval	Same
26.	Maximum OutputVoltage (±15%)	Program 1:51.2V@500Ω94V@2kΩ156V@10kΩ	Program 1:35.5V@500Ω52.5V@2kΩ68.5V@10kΩ	SimilarNote 2
		Program 2:48V@500Ω39.2V@2kΩ49.6V@10kΩ	Program 3:53.5V@500Ω67V@2kΩ68V@10kΩ
		Program 3:69.6V@500Ω98V@2kΩ98V@10kΩ	Program 3:53.5V@500Ω67V@2kΩ68V@10kΩ
		Program 4:57.6V@500Ω76V@2kΩ124V@10kΩ	Program 1:35.5V@500Ω52.5V@2kΩ68.5V@10kΩ
		Program 5:49.6V@500Ω74V@2kΩ134V@10kΩ	Program 2:30V@500Ω52.5V@2kΩ64.5V@10kΩ
		Program 6:57V@500Ω82V@2kΩ138V@10kΩ	Program 1:35.5V@500Ω52.5V@2kΩ68.5V@10kΩ
		Program 7:51.2V@500Ω100V@2kΩ154V@10kΩ	Program 1:35.5V@500Ω52.5V@2kΩ68.5V@10kΩ
		Program 8:64V@500Ω104V@2kΩ134V@10kΩ	Program 6:33V@500Ω55.5V@2kΩ67.5V@10kΩ
		Program 9:	Program 6:
Floor6, Building A, Taixinglong Industrial Park, Hezhou Village, Xixiang Town, Baoan District, Shenzhen City, China.
27.	Maximum OutputCurrent (±15%)	63.2V@500Ω94V@2kΩ128V@10kΩProgram 10:78V@500Ω150V@2kΩ168V@10kΩProgram 11:51.2V@500Ω98V@2kΩ154V@10kΩProgram 12:76V@500Ω152V@2kΩ154V@10kΩ	33V@500Ω55.5V@2kΩ67.5V@10kΩProgram 1:35.5V@500Ω52.5V@2kΩ68.5V@10kΩProgram 1:35.5V@500Ω52.5V@2kΩ68.5V@10kΩProgram 1:35.5V@500Ω52.5V@2kΩ68.5V@10kΩ	SimilarNote 2
		Program 1:102.4mA@500Ω47mA@2kΩ15.6mA@10kΩProgram 2:96mA@500Ω19.6mA@2kΩ4.96mA@10kΩProgram 3:139.2mA@500Ω49mA@2kΩ9.8mA@10kΩProgram 4:115.2mA@500Ω38mA@2kΩ12.4mA@10kΩProgram 5:99.2mA@500Ω37mA@2kΩ13.4mA@10kΩProgram 6:114mA@500Ω	Program 1:71mA@500Ω26.3mA@2kΩ6.9mA@10kΩProgram 3:107mA@500Ω33.5mA@2kΩ6.8mA@10kΩProgram 3:107mA@500Ω33.5mA@2kΩ6.8mA@10kΩProgram 1:71mA@500Ω26.3mA@2kΩ6.9mA@10kΩProgram 2:60mA@500Ω26.3mA@2kΩ6.5mA@10kΩProgram 1:71mA@500Ω
Floor6, Building A, Taixinglong Industrial Park, Hezhou Village, Xixiang Town, Baoan District, Shenzhen City, China.
		41mA@2kΩ	26.3mA@2kΩ
		13.8mA@10kΩ	6.9mA@10kΩ
		Program 7:	Program 1:
		102.4mA@500Ω	71mA@500Ω
		50mA@2kΩ	26.3mA@2kΩ
		15.4mA@10kΩ	6.9mA@10kΩ

		Program 8:	Program 6:
		128mA@500Ω	66mA@500Ω
		52mA@2kΩ	27.8mA@2kΩ
		13.4mA@10kΩ	6.75mA@10kΩ

		Program 9:	Program 6:
		126.4mA@500Ω	66mA@500Ω
		47mA@2kΩ	27.8mA@2kΩ
		12.8mA@10kΩ	6.75mA@10kΩ

		Program 10:	Program 1:
		156mA@500Ω	71mA@500Ω
		75mA@2kΩ	26.3mA@2kΩ
		16.8mA@10kΩ	6.9mA@10kΩ

		Program 11:	Program 1:
		102.4mA@500Ω	71mA@500Ω
		49mA@2kΩ	26.3mA@2kΩ
		15.4mA@10kΩ	6.9mA@10kΩ

		Program 12:	Program 1:
		152mA@500Ω	71mA@500Ω
		76mA@2kΩ	26.3mA@2kΩ
		15.4mA@10kΩ	6.9mA@10kΩ
28.	Pulse width (μsec)	Positive phase: 78μs±10%	Positive phase: 225μs	Similar
		Negative phase:	Negative phase: 225μs	Note 2
		78μs±10%	Interphase interval: 225μs
		Interphase interval:
		70μs±10%
29.	Max. pulse frequency(Hz) [±10%]	Program 1: 46Hz	Program 1: 47.6Hz
		Program 2: 3.3-31Hz	Program 3: 1.62Hz
		Program 3: 1.1Hz	Program 3: 1.62Hz
		Program 4: 65Hz	Program 1: 47.6Hz
		Program 5: 70Hz	Program 2: 3.2~47.6Hz
		Program 6: 2.8-65Hz	Program 1: 47.6Hz
		Program 7: 45-65Hz	Program 1: 47.6Hz
		Program 8: 3.1-52.6Hz	Program 6: 47.6Hz
Floor6, Building A, Taixinglong Industrial Park, Hezhou Village, Xixiang Town, Baoan District, Shenzhen City, China.
	Program 9: 1.8-65HzProgram 10: 1-46HzProgram 11: 46HzProgram 12: 1-46Hz	Program 6: 47.6HzProgram 1: 47.6HzProgram 1: 47.6HzProgram 1: 47.6Hz
30.	Net Charge (µC perpulse)	0μC @500Ω; Method:Balanced waveform	0μC @500Ω; Method:Balanced waveform	Same
31.	Maximum PhaseCharge, (µC)	24.3μC @500Ω	48μC @500Ω	SimilarNote 3
32.	Maximum AverageCurrent, (mA)	0.852mA@500Ω	2.72mA	SimilarNote 4
33.	Maximum CurrentDensity, (mA/cm²,r.m.s.)	0.142mA/cm²@500Ω(Smallestelectrode area 12cm²)	1.36mA/cm² (Smallestelectrode area 4cm²)
34.	Maximum AveragePower Density,(mW/cm²)	5.54mW/cm² @500Ω(Smallest electrode area12cm²)	36.4mW/cm² (Smallestelectrode area 4cm²)
35.	Battery charge	(1) The Lithium batterycan be recharged throughboth AC adaptor andcomputer USB input.(2) When charging isfinished, the LCD willshow full cell of battery.	(1) The Lithium batterycan be recharged throughboth AC adaptor andcomputer USB input.(2) When charging isfinished, the LCD willshow full cell of battery.	Same
36.	Accessories	Self-adhesive electrodes,electrode wires, Batterycharger, USB cable,Screen stylus	Self-adhesive electrodes,electrode wires, Batterycharger, USB cable	SimilarNote 5

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MingHuangDa Electronic Co.,Ltd

Floor6, Building A, Taixinglong Industrial Park, Hezhou Village, Xixiang Town, Baoan District, Shenzhen City, China.

Differences between proposed device and predicate device:

Note 1:

The Patient Leakage Current and Regulated Current or Regulated Voltage between the proposed device and the predicate device has slight difference. But both of them have passed AAMI / ANSI ES 60601-1 test code, so these differences won't raise any new safety and effectiveness issues.

The proposed device has more treatment programs than the predicate device. The output two channels of the proposed device are alternating while the predicate device are synchronous. Because the stimulus delivery between proposed device and predicate device which adopt the same fundamental output technology including same waveform and similar modes will offer the similar treatment effect. Therefore, these items are considered to be substantially equivalent. Also, the proposed device have passed AAMI / ANSI ES 60601-1 and IEC 60601-2-10 test codes, so these differences won't raise any new safety and effectiveness issues.

Note 2:

There are some differences on the maximum output voltage, maximum output current, pulse width and frequency between proposed device and predicate device. Through calculation and measurement, these parameters meet the requirement of AAMI/ANSI ES 60601-2-10 test codes. Specially, the

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MingHuangDa Electronic Co.,Ltd

Floor6, Building A, Taixinglong Industrial Park, Hezhou Village, Xixiang Town, Baoan District, Shenzhen City, China. physiological effectiveness of stimulation is primarily dependent on delivered charge. Therefore these differences won't raise any new safety and effectiveness issues.

Note 3:

The maximum phase charge of the proposed device is less than the predicate device, but the cleared device K121719, which is the predicate device of K143268, has the maximum phase charge of 16.8μC@500Ω. The value of the proposed device is between these two values, therefore this difference won't raise any new safety and effectiveness issues.

Note 4:

The maximum average current, maximum current density and maximum power density have some differences between proposed device and predicate device. Per IEC 60601-2-10 test code, the maximum current density of the proposed device is less than 2mA/cm². Meanwhile, the maximum average power density of the proposed device is less than 0.25W/cm². Therefore these differences won't raise any new safety and effectiveness issues.

Note5:

The proposed device has a screen stylus while the predicate device doesn't have. The proposed device has a touchable display screen and a lock screen button. The screen stylus is to click the display and the lock button is to prevent wrong touch. This function doesn't affect output parameters or operation, so this difference don't raise any safety and effectiveness issues.

4. Safety and Effectiveness of the device:

MHD TENS is safe and effective as the predicate devices cited above. The new device has passed testing according to the safety standards:

ANSI AAMI ES60601-1: 2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD);
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;
ANSI AAMI IEC 60601-1-2:2014, Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances --Requirements And Tests;
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)]
IEC 60601-1-11 Edition 2.0 2015-01, 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 . (General II (ES/EMC))

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.

Regulation Number and Section

§ 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).