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.

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.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA for a TENS & EMS Stimulator (MHD-1083). This document is focused on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing specific acceptance criteria for a novel AI/ML-driven medical device and then proving it meets those criteria through a dedicated performance study.

Therefore, the requested information regarding "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size," "data provenance," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," and "ground truth establishment" cannot be found within this document.

This document details the following:

Acceptance Criteria & Device Performance: The document does not describe acceptance criteria in the typical sense for a new AI/ML algorithm's performance. Instead, it compares the new device's specifications to those of its predicate devices to demonstrate substantial equivalence. The "performance" is implicitly deemed acceptable if it falls within similar ranges or uses similar technology to cleared predicates.
- Table of Acceptance Criteria and Reported Device Performance: Not applicable in the context of an AI/ML algorithm's performance study. The table provided (on pages 6-7) is a comparison of the new device's technical specifications against two predicate devices (K190115 and K133929). It highlights similarities and differences in parameters like power source, output modes, channels, waveform, maximum output voltage/current, pulse width, frequency, and safety compliance. For example:
  - Parameter: Indications for Use
    - New Device: TENS for temporary pain relief; EMS to stimulate healthy muscles for performance.
    - Predicate K190115: TENS for temporary pain relief; PMS (Powered Muscle Stimulation) to stimulate healthy muscles for performance.
    - Predicate K133929: TENS for temporary pain relief; PMS to stimulate healthy muscles for performance.
    - Comparison: Same (in terms of general use).
  - Parameter: Number of Output Modes
    - New Device: 36
    - Predicate K190115: 12
    - Predicate K133929: 25
    - Comparison: Similar (Note 2 states this difference doesn't impact safety/effectiveness).
  - Parameter: Maximum Output Voltage
    - New Device: 82V±20% @ 500Ω; 158V±20% @ 2kΩ; 168V±20% @ 10kΩ
    - Predicate K190115: 78V±15% @ 500Ω; 153V±15% @ 2kΩ; 161V±15% @ 10kΩ
    - Predicate K133929: 44V±10% @ 500Ω; 80V±10% @ 2KΩ; 112V±10% @ 10KΩ
    - Comparison: Similar (Note 3 states differences don't exceed safety limits and meet IEC 60601-2-10 requirements).
Sample sizes for test and training sets: Not applicable. This submission relies on technical specifications and adherence to recognized safety standards rather than a clinical performance study with test/training datasets for an AI algorithm.
Data provenance: Not applicable. No clinical data or images are involved for AI training/testing.
Number of experts and qualifications: Not applicable. Ground truth for an AI algorithm is not established here. The comparison is against established predicate device specifications and recognized safety standards.
Adjudication method: Not applicable.
MRMC comparative effectiveness study: Not applicable, as this is not an AI-assisted diagnostic or therapeutic device that involves human readers.
Standalone performance: Not applicable. The device's operation is purely electrical stimulation, not an AI algorithm.
Type of ground truth: Not applicable. The "ground truth" here is compliance with electrical safety standards (e.g., IEC 60601 series) and demonstrating that the device's functional parameters are within ranges considered safe and effective, similar to already-cleared devices.
How ground truth for training set was established: Not applicable.

In summary, the provided document is a 510(k) submission for an electrical stimulator, not an AI/ML-driven device. Therefore, the specific criteria and study details relevant to AI/ML device acceptance (as outlined in your prompt) are not present. The "proof" of the device meeting "acceptance criteria" here is its demonstrated adherence to relevant electrical safety standards and substantial equivalence to predicate devices, focusing on hardware and electrical characteristics.

Summary

{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)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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.,LTDFloor6, 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 602, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613ChinaE-mail: doris.d@ceve.org.cnTel: 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 3.7Vbattery powered device, offering both transcutaneous electrical nervestimulator (TENS) and electrical muscle stimulation (EMS) qualities in onedevice.TENS & EMS Stimulator has 36 operation programs, which can give certainelectrical pulses through electrode adhesive pads to the suggested area of thebody where the electrodes are placed. And the TENS (Program3,4,6,7,8,9,16,17,19,20,21,22,23,24,28,29,34,36) to be used for temporaryrelief 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 ornormal household work activities by applying current to stimulate nerve.Electrical Muscle Stimulation (EMS) (Program1,2,5,10,11,12,13,14,15,18,25,26,27,30,31,32,33,35) to be used to stimulatehealthy 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, Timingkey, Output sockets, and USB port for battery charging.The LCD screen can display treatment remaining time, battery power,

{5}------------------------------------------------

Shenzhen Minghuangda Electronics Co., LTDFloor6, 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 clearancedate:	---	06/19/2019	11/12/2014	--
3.	Device Name	TENS & EMSStimulator(Model:MHD-1083)	MHD TENS	Health ExpertElectronic Stimulator,Model: AST-300Cand AST-300D	--
4.	Manufacturer	ShenzhenMinghuangdaElectronics Co.,LTD	MingHuangDaElectronic Co.,Ltd	Shenzhen OSTOTechnology CompanyLimited	--
5.	Indications for Use	TranscutaneousElectrical NerveStimulation (Program3,4,6,7,8,9,16,17,19,20,21,22,23,24,28,29,34,36):To be used fortemporary relief ofpain associated withsore and achingmuscles in theshoulder, waist,back, back of theneck, arm, leg, andfoot due to strainfrom exercise ornormal householdwork activities byapplying current tostimulate nerve.ElectricalMuscleStimulation (Program1,2,5,10,11,12,13,14,15,18,25,26,27,30,31,32,33,35):It is intended to beused to stimulatehealthy muscles inorder to improve andfacilitate muscleperformance.	TranscutaneousElectrical NerveStimulation (Program2, 3, 4, 6, 8, 9):To be used fortemporary relief ofpain associated withsore and achingmuscles in theshoulder, waist, back,upper extremities(arm), and lowerextremities (leg) dueto strain from exerciseor normal householdwork activities.Powered MuscleStimulation (Program1, 5, 7, 10, 11, 12):It is intended to beused to stimulatehealthy muscles inorder to improve andfacilitate muscleperformance.	TENS (Mode 925)To be used fortemporary relief ofpainassociated with soreandaching muscles in theshoulder, waist, back,back of the neck, arm,leg, and foot due tostrain from exercise ornormal householdworkactivities by applyingcurrent to stimulatenerve.PMS (Mode 18)It is intended tostimulate healthymuscles in order toimprove and facilitatemuscle performance.	Same
6.	Type of use	OTC	OTC	OTC	Same
7.	Power Source(s)	DC 3.7V lithiumbattery	DC 3.7V lithiumbattery	Adaptor Input: 100-240Vac, 50-60Hz,0.1AOutput: 5Vdc, 1AUnit Input: 5Vdc, 1A	Same
	- Method of LineCurrent Isolation	Type BF	Type BF	Type BF Applied Part	Same
	- Patient LeakageCurrent	--	--	--	Same
	- NormalCondition (μΑ)	< 10μΑ	< 10μΑ	AC: 54.5μA,DC: 0.5μA
	- Single FaultCondition (μΑ)	< 50μΑ	< 50μΑ	AC:120.0μA,DC: 0.6μA
8.	Average DC currentthrough electrodeswhen device is onbut no pulses arebeing applied (µA)	< 0.01μA	< 0.01μA	< 0.01μA	Same
9.	Number of OutputModes	36	12	25	SimilarNote 2
10.	Number of Outputchannels:	2	2	2	Same
	- Synchronous orAlternating?	Alternating	Alternating	Synchronous	Same
	- Method of ChannelIsolation	Voltage transformerIsolation	Voltage transformerIsolation	Voltage TransformIsolation"BODY ▼" and"BODY ▼" buttonsfor body channel,"SOLE ▲" and"SOLE▼" buttonsfor feet channel	Same
12.	Regulated Current orRegulated Voltage?	Regulated current	Regulated current	Voltage Control	Same
13.	Software/Firmware/MicroprocessorControl?	Software	Software	Yes	Same
14.	Automatic OverloadTrip?	No	No	No	Same
15.	Automatic No-LoadTrip?	No	No	No	Same
16.	Automatic Shut Off?	Yes	Yes	Yes	Same
17.	User OverrideControl?	No	Yes	Yes	SimilarNote 1
18.	IndicatorDisplay:	On/OffStatus?	Yes	Yes	Yes	Same
		LowBattery?	Yes	Yes	No	Same
		Voltage/CurrentLevel?	No	Yes	Yes	SimilarNote 1
19.	Timer Range(minutes)		0 ~ 60 minutes, 10min/step	10 ~ 60 minutes, 10min/step	25min	SimilarNote 2
20.	Compliance withVoluntaryStandards?		Yes.IEC 60601-1,IEC 60601-1-2,IEC 60601-2-10,IEC 62133,IEC 60601-1-11	Yes.IEC 60601-1,IEC 60601-1-2,IEC 60601-2-10,IEC 62133,IEC 60601-1-11	Yes.IEC 60601-1,IEC 60601-1-2,IEC 60601-2-10,ISO 10993-5,ISO 10993-10	Same
21.	Compliance with 21CFR 8988?		Yes	Yes	Yes	Same
22.	Weight (grams)		50g	110g	2Kg (Withoutaccessories)	SimilarNote 2
23.	Dimensions (mm)[W x H x D]		93.85410.8mm	132.865.813.8mm	428mm x 428.8mm x185mm	SimilarNote 2
24.	Housing Materials &Construction		ABS+aluminiumalloy	ABS+aluminiumalloy	Main unit: ABSplastic	Same
25.	Waveform		Pulsed, symmetric,biphasic	Pulsed, symmetric,biphasic	Pulsed, symmetric,biphasic	Same
26.	Shape		Rectangular, withinterphase interval	Rectangular, withinterphase interval	Rectangular, withinterphase interval	Same
27.	Maximum OutputVoltage (volts)		82V±20% @ $500Ω$158V±20% @ $2kΩ$168V±20% @ $10kΩ$	78V±15% @ $500Ω$153V±15% @ $2kΩ$161V±15% @ $10kΩ$	44V±10% @ $500Ω$80V±10% @ $2KΩ$112V±10% @ $10KΩ$	SimilarNote 3
28.	Maximum OutputCurrent (specifyunits)		164mA±20% @ $500Ω$79mA±20% @ $2kΩ$16.8mA±20%@ $10kΩ$	156mA±15% @ $500Ω$76.5mA±15% @ $2kΩ$16.1mA±15%@ $10kΩ$	88mA±10% @ $500Ω$40mA±10% @ $2KΩ$11.2mA±10%@ $10KΩ$
29.	Pulse width (usec)		90μs±20%	Positive phase:78μs±10%Negative phase:78μs±10%Interphase interval:70μs±10%	120µs
30.	Pulse Period (msec)		10.3~833.3ms	14.3~1000ms	129ms
31.	Max. pulsefrequency (Hz) [orRate (pps)]		1.2~96.8Hz±20%	1~70Hz	77.3Hz
32.	Net Charge (µC per		0µC @500Ω; Method:	0µC @500Ω; Method:	0µC @500Ω; Method:	Same
	pulse)	Balanced waveform	Balanced waveform	Balanced waveform
33.	Maximum PhaseCharge, (μC)	$14.76μC @500Ω$	$12.17μC@500Ω$	$12.780μC @500Ω$	SimilarNote 4
34.	Maximum AverageCurrent, (mA)	$1.16mA @500Ω$	$0.852mA@500Ω$	$0.968mA @ 500Ω$
35.	Maximum CurrentDensity, (mA/cm²,r.m.s.)	$0.22mA/cm² @500Ω$(Smallest electrodearea 10cm²)	$0.142mA/cm²@500Ω$(Smallest electrodearea 12cm²)	$0.235mA/cm² @500Ω$
36.	Maximum AveragePower Density,(mW/cm²)	$14.52mW/cm² @500Ω$(Smallest electrode area 10cm²)	$5.54mW/cm² @500Ω$(Smallest electrodearea 12cm²)	$1.38mW/cm² @500Ω$
37.	Battery charge	(1) The Lithiumbattery can berecharged through ACadaptor input.(2) When charging isfinished, the LCD willshow full cell ofbattery.	(1) The Lithiumbattery can berecharged throughboth AC adaptor andcomputer USB input.(2) When charging isfinished, the LCD willshow full cell ofbattery.	Not published	SimilarNote 2
38.	Accessories	Self-adhesiveelectrodes, electrodewires, Batterycharger, USB cable	Self-adhesiveelectrodes, electrodewires, Batterycharger, USB cable,Screen stylus	Not published	SimilarNote 2

{7}------------------------------------------------

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

{8}------------------------------------------------

Shenzhen Minghuangda Electronics Co.,LTD

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

{9}------------------------------------------------

Shenzhen Minghuangda Electronics Co.,LTD

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

Comparison in details:

Note 1:

The user override control, voltage/current level and battery charge of the proposed device are different from the primary predicate device. Considering the proposed device and predicate device adopt the same fundamental output technology and similar treatment effect. Therefore, this item is considered to be substantially equivalent. Also, the proposed device had passed AAMI / ANSI ES60601-2-10 tests, so these differences don't raise any new safety and effectiveness issues.

Note 2

The number of output modes, time range, weight, dimensions, appearances and accessories of the proposed device are a little different from the predicate device, depending on the design and sales requirements of the product,but these differences do not impact safety and effectiveness.

Note 3:

There are some differences on the maximum output voltage and maximum output current between the proposed device and predicate device. Based on the calculation of maximum current density, maximum average power density, these parameters don't exceed the safety limit. All deviation and the worst case have been considered in risk analysis report, and these parameters have met the requirements of IEC 60601-2-10. So these differences will not raise any new safety and effectiveness issues. Although the pulse width, pulse period and frequency of the proposed device are a little different and bring up a difference in the maximum charge per phase the difference will not alter the ability of the device from performing similar to the predicate device. The small difference of function specifications will not raise any safety or effectiveness issue.

{10}------------------------------------------------

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

Note 4:

Based on the calculation of maximum current density, maximum average power density, these parameters don't exceed the safety limits of 2 mA/cm² and 0.25 W/cm². All deviation and the worst case have been considered in risk analysis report, and these parameters have passed IEC 60601-2-10 test codes. So these differences will not raise any new safety and effectiveness issues. Although the parameters of the proposed device are a little different from the predicate device, but they are all compliance with IEC 60601-2-10 requirements. So, the minor difference in specification will not raise any safety or effectiveness issue.

5. Safety and Effectiveness of the device:

TENS & EMS Stimulator(Model:MHD-1083) is as 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 & 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.

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).