TENS(1,3,4,5,6,21): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS(2,7,8,9,10,11,12,13,14,15,16,17,18,19,20,22,23,24): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Model: SM9126
TENS(3,4,5,6,11,12,16): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS(1,2,7,8,9,10,13,14,15): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Model: SM9186
TENS(3,4,7,8,11): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS(1,2,5,6,9,10,12): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Model: SM9196
TENS(1015): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS(19): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Device Description

TENS & PMS is a portable and DC 3.7V battery powered multifunction device with multiple models, offering both Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS) qualities in one device. The device is equipped with accessories of electrode pads, electrode cables, a battery charger, and one USB cable. The electrode cables are used to connect the pads to the device; the USB cable is used to connect the charger and the built-in lithium battery. All accessories, including USB cables, electrode pads, electrode cables, chargers can only be changed or replaced by a qualified person.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a TENS & PMS device. This submission aims to demonstrate substantial equivalence to an already legally marketed predicate device (K121719). The document focuses on comparing the technical characteristics and performance of the new device models (SM9079, SM9126, SM9186, SM9196) against the predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are implicitly defined by the safety and performance parameters of the legally marketed predicate device (K121719) and compliance with various recognized standards. The reported device performance is demonstrated through the comparative tables (Table 1, 2, 3, 4) where the new device's parameters are listed alongside the predicate device's, and through the statement of compliance with specific IEC and ANSI/AAMI standards.

Since the tables in the document are already in a comparative format, I will summarize the key parameters and their reported performance for one of the new models (SM9079) against the predicate. The "Remark" column in the original tables already serves as a concise statement of whether the new device meets or is similar to the predicate.

Table: Acceptance Criteria and Reported Device Performance (Example: Model SM9079 vs. Predicate K121719)

Parameter / Acceptance Criteria (Derived from Predicate)	Reported Device Performance (New Device SM9079)	Meets Criteria?	Notes
General Characteristics
Manufacturer	Hong Qiangxing (Shenzhen) Electronics Limited	Yes	Same
Intended Use (TENS)	Temporary relief of pain for specific body parts due to strain	Yes	Same (Expanded list of programs, but comparable)
Intended Use (PMS)	Stimulate healthy muscles to improve performance	Yes	Same (Expanded list of programs, but comparable)
Type of Use	OTC	Yes	Same
Power Source	DC 3.7V lithium battery	Yes	Same
Method of Line Current Isolation	Type BF	Yes	Same
Patient Leakage Current (Normal Condition)	< 10μA	Yes	Same
Patient Leakage Current (Single Fault Condition)	< 50μA	Yes	Same
Average DC current through electrodes	< 0.01μA	Yes	Same
Number of Output Modes	24	Similar	More treatment programs, all comparable to predicate's mode 3. No new safety/effectiveness issues.
Number of Output Channels	2	Yes	Same
Synchronous or Alternating Channel Output	Alternating	Similar	Different from predicate's synchronous, but same technology and treatment effect. No new safety/effectiveness issues.
Method of Channel Isolation	Voltage transformer Isolation	Yes	Same
Regulated Current or Voltage	Voltage control	Yes	Same
Software/Firmware/Microprocessor Control	Software	Yes	Same
Automatic Overload Trip?	No	Yes	Same
Automatic No-Load Trip?	No	Yes	Same
Automatic Shut Off?	Yes	Yes	Same
User Override Control?	Yes	Yes	Same
Indicator (On/Off Status)	Yes	Yes	Same
Indicator (Low Battery)	Yes	Yes	Same
Indicator (Voltage/Current Level)	Yes	Yes	Same
Timer Range	10 ~ 60 minutes, 10 min/step	Yes	Same
Biocompatibility	All user directly contacting materials comply with ISO10993-5 and ISO10993-10 requirements.	Yes	Same
Accessories	Self-adhesive electrodes, electrode wires, Battery charger, USB cable	Yes	Same
Physical Characteristics
Weight	102g±5g	Similar	Difference in weight and dimensions noted, but deemed not to raise safety/effectiveness issues.
Dimensions	6012312mm	Similar	Difference in weight and dimensions noted, but deemed not to raise safety/effectiveness issues.
Housing Materials & Construction	ABS	Yes	Same
Output Specifications (Max Values from Table 5 for SM9079 vs. Predicate Mode 3/1/2)
Waveform	Pulsed, symmetric, biphasic	Yes	Same
Shape	Rectangular	Yes	Same
Max Output Voltage (@500Ω)	42V±20%	Similar	Predicate 42V±10%. Differences in pulse width, frequency, period allowed as parameters don't exceed safety limits and passed IEC 60601-2-10 tests.
Max Output Current (@500Ω)	84mA±20%	Similar	Predicate 84mA±10%. Differences in pulse width, frequency, period allowed as parameters don't exceed safety limits and passed IEC 60601-2-10 tests.
Pulse Width	190µs (max)	Similar	Predicate 100µs. Differences in pulse width, frequency, period allowed as parameters don't exceed safety limits and passed IEC 60601-2-10 tests.
Pulse Period	40-1070ms (range)	Similar	Predicate 9.3~850ms. Differences in pulse width, frequency, period allowed as parameters don't exceed safety limits and passed IEC 60601-2-10 tests.
Max Pulse Frequency	0.935-25Hz±10% (range)	Similar	Predicate 110Hz. Differences in pulse width, frequency, period allowed as parameters don't exceed safety limits and passed IEC 60601-2-10 tests.
Net Charge (per pulse)	0µC @500Ω; Balanced waveform	Yes	Same
Max Phase Charge (@500Ω)	13.30µC@500Ω	Similar	Predicate 16.8µC@500Ω. Differences in these parameters allowed as they don't exceed safety limits and passed IEC 60601-2-10 tests.
Max Current Density (@500Ω)	0.065mA/cm²	Yes	Meets max current density <2mA/cm² (predicate value not given explicitly here, but stated in Note 4 for SM9126).
Max Average Power Density (@500Ω)	2.64mW/cm²	Yes	Meets max average power density <0.25W/cm² (predicate value not given explicitly here, but stated in Note 4 for SM9126).
Compliance with Standards
ANSI AAMI ES60601-1	Yes	Yes	Same
IEC 60601-2-10	Yes	Yes	Same
ANSI AAMI IEC 60601-1-2	Yes	Yes	Same
IEC 62133	Yes	Yes	Same
ANSI AAMI HA60601-1-11	Yes	Yes	Same
21 CFR 898 (if applicable)	Yes	Yes	Same

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

The document explicitly states that the new devices have "passed testings according to the following standards" and that the "conclusion drawn from the testings are that the new devices are substantially equivalent to the predicate device." These "testings" refer to compliance with various medical device standards (ANSI AAMI ES60601-1, IEC 60601-2-10, ANSI AAMI IEC 60601-1-2, IEC 62133, ANSI AAMI HA60601-1-11).

However, the document does not provide details about a clinical study or a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The submission is based on a comparison of technical specifications and performance against a predicate device and adherence to recognized standards, rather than a separate clinical trial with a defined sample size. The testing appears to be functional and electrical safety testing as per the listed standards.

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

Given that a clinical study or human-in-the-loop performance evaluation with a test set requiring expert ground truth is not described in the provided text, information on the number and qualifications of experts for establishing ground truth is not available. The evaluation is based on technical specifications and compliance with standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Since no clinical test set requiring human adjudication is mentioned, there is no information provided on any adjudication method.

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

The device described is a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS). It is a physical therapy device and not an AI-assisted diagnostic or imaging interpretation device. Therefore, a Multi Reader Multi Case (MRMC) comparative effectiveness study focusing on human readers improving with AI assistance would be irrelevant and is not mentioned in this submission.

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

Again, this is a physical therapy device, not an algorithm, so no standalone algorithm performance evaluation is applicable or mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this type of device, the "ground truth" for demonstrating substantial equivalence and safety/effectiveness relies on:

Compliance with recognized electrical safety and performance standards: This includes specific limits for voltage, current, pulse characteristics, leakage current, and electromagnetic compatibility.
Comparison of technical specifications with a legally marketed predicate device: The predicate device itself has established safety and effectiveness. The "ground truth" is that the predicate device is safe and effective when used as intended, and the new device demonstrates similar performance and characteristics to be considered equivalent.
Biocompatibility testing: Compliance with ISO10993-5 and ISO10993-10 for materials directly contacting the user.

There is no mention of expert consensus, pathology, or outcomes data from a clinical trial for this specific submission. The "ground truth" is established by adherence to existing regulatory frameworks and engineering standards.

8. The sample size for the training set

As this is not an AI/machine learning device, the concept of a "training set" is not applicable and therefore, no sample size for a training set is provided.

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

As the concept of a training set is not applicable, no information is provided on how its ground truth would be established.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 11, 2020

Hong Qiangxing (Shen Zhen) Electronics Limited % Doris Dong Manager Shanghai CV Technology Co., Ltd. Room 903, No. 19 Dongbao Road, Songjiang Area Shanghai, Shanghai 201613 China

Re: K201354

Trade/Device Name: TENS & PMS Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX. NUH Dated: September 3, 2020 Received: September 14, 2020

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.

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

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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 medical devices and radiation-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 Amber Ballard, PhD Assistant Director 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) K201354

Indications for Use (Describe)

Device Name TENS & PMS

Model:	SM9079
TENS	(1,3,4,5,6,21):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS	(2,7,8,9,10,11,12,13,14,15,16,17,18,19,20,22,23,24):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Model:	SM9126
TENS	(3,4,5,6,11,12,16):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS	(1,2,7,8,9,10,13,14,15):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Model:	SM9186
TENS	(3,4,7,8,11):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS	(1,2,5,6,9,10,12):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Model:	SM9196
TENS	(10~15):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS	(1~9):
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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4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126

510(k) Summary

[As required by 21 CFR 807.92]

1. Submission Information:

510(k) Number:	K201354
Date:	December 11, 2020
Type of 510(k) Submission:	Traditional
Basis for 510(k) Submission:	New device
Submitter/Manufacturer:	Hong Qiangxing(Shen Zhen) Electronics Limited4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'anDistrict, Shenzhen City, Guangdong, China 518126
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:	TENS & PMS
Common Name:	TENS & PMS
Classification Name:	Powered muscle stimulatorTranscutaneous electrical nerve stimulator for pain relief
Regulation Number:	21 CFR 890.5850, 21 CFR 882.5890
Product Code:	NGX, NUH
Device Class:	II
Review Panel:	Neurology & Physical Medicine
Device Description:	TENS & PMS is a portable and DC 3.7V battery powered multifunctiondevice with multiple models, offering both Transcutaneous Electrical NerveStimulation (TENS) and Powered Muscle Stimulation (PMS) qualities inone device.The device is equipped with accessories of electrode pads, electrode cables,a battery charger, and one USB cable. The electrode cables are used toconnect the pads to the device; the USB cable is used to connect the chargerand the built-in lithium battery. All accessories, including USB cables,electrode pads, electrode cables, chargers can only be changed or replacedby a qualified person.
Indications for use:	Model: SM9079TENS(1,3,4,5,6,21):To be used for temporary relief of pain associated with sore and achingmuscles in the shoulder, waist, back, neck, upper extremities (arm), andlower extremities (leg) due to strain from exercise or normal householdwork activities.PMS(2,7,8,9,10,11,12,13,14,15,16,17,18,19,20,22,23,24):It is intended to be used to stimulate healthy muscles in order to improveand facilitate muscle performance.

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4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126

Model: SM9126

TENS(3.4.5.6.11.12.16):

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

PMS(1,2,7,8,9,10,13,14,15):

It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Model: SM9186

TENS(3,4,7,8,11):

PMS(1,2,5,6,9,10,12):

It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Model: SM9196

TENS(10~15):

PMS(1~9):

It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

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4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126 3. Working principle

The device uses electrodes to send a specific electric current to the skin. TENS(Transcutaneous electrical nerve stimulation) mode is to relieve pain using electrical stimulation. PMS(Powered Muscle Stimulation) mode is to stimulate healthy muscles in order to improve performance by electrical stimulation.

4. Substantial Equivalence to Predicate device: Basic Unit Characteristics

Table 1-

Parameters	New Device	Predicate Device	Remark
510(k) Number	K201354	K121719	--
Device Name	TENS & PMS	SM TENS & PMS	--
Model	SM9079	No	--
Manufacturer	Hong Qiangxing (Shenzhen)Electronics Limited	Hong Qiangxing (Shenzhen)Electronics Limited	Same
Intended use	TENS(1,36,21):To be used for temporary reliefof pain associated with sore andaching muscles in the shoulder,waist, back, neck, upperextremities (arm), and lowerextremities (leg) due to strainfrom exercise or normalhousehold work activities.PMS(2,720,22~24):It is intended to be used tostimulate healthy muscles inorder to improve and facilitatemuscle performance.	TENS(1,3,4,5,6):To be used for temporary reliefof pain associated with sore andaching muscles in the shoulder,waist, back, neck, upperextremities (arm), and lowerextremities (leg) due to strainfrom exercise or normalhousehold work activities.PMS(1,2,3,6):It is intended to be used tostimulate healthy musclesinorder to improve and facilitatemuscle performance.	Same
Type of use	OTC	OTC	Same
Power Source(s)	DC 3.7V lithium battery	DC3.7Vlithium battery	Same
- Method of LineCurrent Isolation	Type BF	Type BF	Same
Patient Leakage		--	Same
Current
	Normal	< 10μΑ	< 10μΑ
Condition (μΑ)
	- Single Fault	< 50μA	< 50μA
Condition (μΑ)
Average	DC	< 0.01μA	< 0.01μA	Same
current	through
electrodes	when
device is on but no
pulses are being
applied (µA)
Number of Output		24	6	Similar
Modes				Note 1
Number of Output		2	2	Same
channels:
		Alternating	Synchronous	Similar Note 2
Synchronous	Or
Alternating?
	- Method of	Voltage transformer	Voltage transformer	Same
Channel Isolation		Isolation	Isolation
Regulated Current		Voltage control	Voltage control	Same
or	Regulated
Voltage?
Software/Firmwar
		Software	Software	Same
e/MicroprocessorControl?

Automatic		No	No	Same
Overload Trip?
Automatic		No	No	Same
No-Load Trip?
Automatic	Shut	Yes	Yes	Same
Off?
User	Override	Yes	Yes	Same
Control?
Indicato	On/Off	Yes	Yes	Same
r	Status
Display	Low	Yes	Yes	Same
	Battery
	Voltage	Yes	Yes	Same
	/Curren
	t Level
Timer	Range	10 ~ 60 minutes, 10	10 ~ 60 minutes, 10	Same
(minutes)		min/step	min./step
Compliance	with	Yes.	Yes.	Same
Voluntary		AAMI/ANSI ES 60601-1	AAMI/ANSI
	Hong Qiangxing(Shen Zhen) Electronics Limited4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126
Standards?	IEC 60601-1-2, IEC60601-2-10, IEC 62133,HA 60601-1-11	ES60601-1, IEC 60601-1-2, IEC60601-2-10, IEC62133, IEC 60601-1-11	Same
Compliance with21 CFR 898?	Yes	Yes	Same
Weight (grams)	102g±5g	140g	Similar Note 1
Dimensions (mm)[W x H x D]	6012312mm	83429mm
Housing Materials& Construction	ABS	ABS	Same
Waveform	Pulsed, symmetric,biphasic	Pulsed, symmetric,biphasic	Same
Shape	Rectangle	Rectangle	Same
Maximum OutputVoltage (volts)	42V±20% @500Ω	42V±10% @500Ω	Similar Note 3
Maximum OutputCurrent (specifyunits)	84mA±20% @500Ω	84mA±10% @500Ω
Pulse width (µsec)	190µs	100µs
Pulse Period(msec)	40-1070ms	9.3~850ms
Max. pulsefrequency (Hz) [orRate (pps)]	0.935-25Hz±10%	110Hz
Net Charge (µCper pulse)	0µC @500Ω; Method:Balanced waveform	0µC @500Ω; Method: Balancedwaveform	Same
Maximum PhaseCharge, (µC)	13.30µC@500Ω	16.8µC @500Ω	Similar
MaximumAverage Current,(mA)	0.78mA	0.924mA	Similar Note 4
Maximum CurrentDensity, (mA/cm²,r.m.s.)	0.065mA/cm² @500Ω	0.462mA/cm²
MaximumAverage PowerDensity,(mW/cm²)	2.64mW/cm² @500Ω	9.702mW/cm²
Accessories	Self-adhesive electrodes,electrode wires, Battery charger,USB cable	Self-adhesive electrodes,electrode wires,Battery charger,USB cable	Same
Biocompatibility	All user directly	All user directly	Same

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Hong Qiangxing(Shen Zhen) Electronics Limited

Hong Qiangxing(Shen Zhen) Electronics Limited
4F, Jingcheng Building, Xicheng Industrial Zon, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126

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Hong Qiangxing(Shen Zhen) Electronics Limited

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

4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126

contacting materials arecompliance withISO10993-5 and ISO10993-10requirements.	contacting materials arecompliance withISO10993-5 and ISO10993-10requirements.
--------------------------------------------------------------------------------------------	--------------------------------------------------------------------------------------------

Comparison in details:

Note 1:

The proposed device SM9079 has more treatment programs than the predicate device K121719, all treatment programs of proposed device are comparable to the mode 3 of the predicate device. The proposed device doesn't have treatment program to compare with the mode 6 of the predicate device because predicate device's mode 6 are variation waveform of the mode 1 to mode 3. All of the treatment programs have passed the IEC 60601-2-10 and AAMI / ANSI ES60601-1 test codes. So this difference doesn't raise any safety or effectiveness issue. And the weight, dimensions, appearance of proposed device SM9079 are a little different from predicate device K121719, but these differences will not raise any safety or effectiveness issue.

Note 2:

The output channels of the proposed device is alternating while the predicate device is synchronous. Because 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 ES60601-1 and IEC 60601-2-10 test codes, so these differences won't raise any new safety and effectiveness issues.

Note 3:

There are some differences on the pulse width, frequency, pulse period and deviation between 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 passed IEC 60601-2-10 test codes. Therefore, these differences won't raise any new safety and effectiveness issues.

Note 4:

The maximum average current of proposed device is smaller than that of the predicate device which means the better safety. The maximum current density, maximum average power density have some differences between proposed device and predicate device due to they are calculated by different electrode area. Both of them meet maximum current density <2mA/cm² and maximum average power density <0.25W/cm². Therefore these differences won't raise any new safety and effectivenessissues.

Final conclusion:

The subject device SM9079 is substantial Equivalent to the predicate device K121719.

Table 2-

Parameters	New Device	Predicate Device	Remark
510(k) Number	K201354	K121719	--

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							4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126

Device Name	TENS & PMS	SM TENS & PMS	--
Model	SM9126	No	--
Manufacturer	Hong Qiangxing (Shenzhen)Electronics Limited	Hong Qiangxing (Shenzhen)Electronics Limited	Same
Intended use	TENS(36,11,12,16):To be used for temporary reliefof pain associated with sore andaching muscles in the shoulder,waist, back, neck, upperextremities (arm), and lowerextremities (leg) due to strainfrom exercise or normalhousehold work activities.PMS(1,2,710,13~15):It is intended to be used tostimulate healthy muscles inorder to improve and facilitatemuscle performance.	TENS(1,3,4,5,6):To be used for temporary relief ofpain associated with sore and achingmuscles in the shoulder, waist, back,neck, upper extremities (arm), andlower extremities (leg) due to strainfrom exercise or normal householdwork activities.PMS(1,2,3,6):It is intended to be used to stimulatehealthy muscles in order to improveand facilitate muscle performance.	Same
Type of use	OTC	OTC	Same
Power Source(s)	DC 3.7V lithium battery	DC 3.7V lithium battery	Same
- Method of LineCurrent Isolation	Type BF	Type BF	Same
- Patient LeakageCurrent	--	--	Same
-- NormalCondition (μΑ)	< 10μΑ	< 10μΑ
- Single FaultCondition (μΑ)	< 50μA	< 50μA
Average DC currentthrough electrodeswhen device is onbut no pulses arebeing applied (µA)	< 0.01μA	< 0.01μA	Same
Number of OutputModes	16	6	SimilarNote 1
Number of Outputchannels:	2	2	Same
- Synchronousor Alternating?	Synchronous	Synchronous	Same
- Method ofChannel Isolation	Voltage transformer Isolation	Voltage transformer Isolation	Same
Regulated Currentor RegulatedVoltage?	Voltage control	Voltage control	Same
Software/Firmware/	Software	Software	Same

{11}------------------------------------------------

			Hồng Qiangxing(Shen Zhen) Electronics Limited4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126
MicroprocessorControl?
Automatic OverloadTrip?		No	No	Same
Automatic No-LoadTrip?		No	No	Same
Automatic Shut Off?		Yes	Yes	Same
User	OverrideControl?	Yes	Yes	Same
Indicator	On/OffStatus?	Yes	Yes	Same
Display	LowBattery?	Yes	Yes	Same
	Voltage/CurrentLevel?	Yes	Yes	Same
Timer(minutes)	Range	10 ~ 60 minutes, 10 min/step	10 ~ 60 minutes, 10 min./step	Same
Compliance	withVoluntaryStandards?	Yes.AAMI/ANSI ES 60601-1, IEC60601-1-2, IEC 60601-2-10, IEC62133, HA 60601-1-11	Yes.AAMI/ANSI ES60601-1, IEC60601-1-2, IEC 60601-2-10, IEC62133, IEC 60601-1-11	Same
Compliance with 21CFR 8988?		Yes	Yes	Same
Weight (grams)		55g±5g	140g	Similar
Dimensions (mm)[W x H x D]		50.3793.410.4mm	83429mm	Note 1
Housing	Materials& Construction	ABS	ABS	Same
Waveform		Pulsed, symmetric, biphasic	Pulsed, symmetric, biphasic	Same
Shape		Rectangular	Rectangular	Same
Maximum OutputVoltage (volts)		46.4V±20% @500Ω	42V±10% @500Ω	SimilarNote 2
Maximum	OutputCurrent (specifyunits)	92.8mA±20% @500Ω	84mA±10% @500Ω	Same
Pulse width (usec)		220μs	100μs	Same
Pulse Period (msec)		5-680ms	9.3~850ms	Same
Max. pulsefrequency (Hz) [orRate (pps)]		1.47-212.5Hz±10%	110Hz	Same
	Net Charge (μC perpulse)	0μC @500Ω; Method: Balancedwaveform	0μC @500Ω; Method: Balancedwaveform	Same
Maximum	PhaseCharge, (μC)	17.26μC@500Ω	16.8μC @500Ω	Similar

{12}------------------------------------------------

4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126

Maximum AverageCurrent, (mA)	2.056mA	0.924mA	SimilarNote 3
Maximum CurrentDensity, (mA/cm²,r.m.s.)	0.119mA/cm² @500Ω	0.462mA/cm²
Maximum AveragePower Density,(mW/cm²)	5.21mW/cm² @500Ω	9.702mW/cm²
Biocompatibility	All user directly contactingmaterials are compliance withISO10993-5 and ISO10993-10requirements.	All user directly contacting materialsare compliance with ISO10993-5 andISO10993-10 requirements.	Same
Accessories	Self-adhesive electrodes,electrode wires, Battery charger,USB cable	Self-adhesive electrodes, electrodewires, Battery charger, USB cable	Same

Comparison in details:

Note 1:

The proposed device SM9126 has more treatment programs than the predicate device K121719, all treatment programs of proposed device are comparable to the mode 1 to mode 3 of the proposed device doesn't have treatment program to compare with the mode 6 of the predicate device because predicate device's mode 6 are variation waveform of the mode 1 to mode 3. All of the treatment programs have passed the IEC 60601-2-10 and AAMI / ANSI ES60601-1 test codes. So this difference doesn't raise any safety or effectiveness issue. And the weight, dimensions, appearance of proposed device SM9126 are a little different from predicate device K121719, but these differences are insignificant in the terms of safety or effectiveness.

Note 2:

There are some differences on the maximum output voltage, maximum output current, pulse width, frequency, pulse period, deviation between 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 passed IEC 60601-2-10 test codes. So these differences won't raise any new safety and effectiveness issues.

Note 3:

The maximum current density, maximum average power density have some differences between proposed device and predicate device due to they are calculated by different electrode area. Both of them met maximum current density <2mA/cm² and maximum average power density <0.25W/cm². Therefore these differences won't raise any new safety and effectiveness issues.

Final conclusion:

The subject device SM9126 is substantial Equivalent to the predicate device K121719.

{13}------------------------------------------------

4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126 Table 3-

Parameters		New Device	Predicate Device	Remark
510(k) Number		K201354	K121719	--
Device Name		TENS & PMS	SM TENS & PMS	--
Model		SM9186	No	--
Manufacturer		Hong Qiangxing(Shenzhen) ElectronicsLimited	Hong Qiangxing (Shenzhen)Electronics Limited	--
Intended use		TENS(3,4,7,8,11):To be used for temporaryrelief of pain associatedwith sore and achingmuscles in the shoulder,waist, back, neck, upperextremities (arm), andlower extremities (leg) dueto strain from exercise ornormal household workactivities.PMS(1,2,5,6,9,10,12):It is intended to be used tostimulate healthy musclesin order to improve andfacilitatemuscleperformance.	TENS(1,3,4,5,6):To be used for temporaryrelief of pain associated with sore andaching muscles in the shoulder,waist, back, neck, upperextremities (arm), and lowerextremities (leg) due to strainfrom exercise or normalhousehold work activities.PMS(1,2,3,6):It is intended to be used tostimulate healthy muscles inorder to improve and facilitatemuscle performance.	Same
Type of use		OTC	OTC	Same
Power Source(s)		DC 3.7V lithium battery	DC 3.7V lithium battery	Same
- Method of Line Current Isolation		Type BF	Type BF	Same
- Patient Leakage Current- Normal Condition (μΑ)		< 10μA	< 10μA	Same
- Single Fault Condition (μΑ)		< 50μA	< 50μA
Average DC current throughelectrodes when device is on but nopulses are being applied (µA)		< 0.01μA	< 0.01μA	Same
Number of Output Modes		12	6	SimilarNote 1
Number of Output channels:		2	2	Same
	- Synchronous or Alternating?	Alternating	Synchronous	SimilarNote 2
	- Method of Channel Isolation	Voltage transformerIsolation	Voltage transformer Isolation	Same
RegulatedVoltage?	Current or Regulated	Voltage control	Voltage control	Same
Software/Firmware/MicroprocessorControl?		Software	Software	Same
Automatic Overload Trip?		No	No	Same
Automatic No-Load Trip?		No	No	Same
Automatic Shut Off?		Yes	Yes	Same
User Override Control?		Yes	Yes	Same
IndicatorOn/Off Status		Yes	Yes	Same
Display	Low Battery	Yes	Yes	Same
	Voltage/CurrentLevel	Yes	Yes	Same
Timer Range (minutes)		10 ~ 60 minutes, 10min/step	10 ~ 60 minutes, 10 min./step	Same
ComplianceStandards?	withVoluntary	Yes.AAMI/ANSI ES 60601-1	Yes.AAMI/ANSI ES60601-1 IEC	Same
4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126
	IEC 60601-1-2, IEC 60601-2-10, IEC 62133, HA 60601-1-11	IEC 60601-1-2, IEC 60601-2-10, IEC 62133, IEC 60601-1-11
Compliance with 21 CFR 8988?	Yes	Yes	Same
Weight (grams)	$50\pm5$ g	140g	Similar
Dimensions (mm) [W x H x D]	52.99211mm	83429mm	Note 1
Housing Materials & Construction	ABS	ABS	Same
Waveform	Pulsed, symmetric, biphasic	Pulsed, symmetric, biphasic	Same
Shape	Rectangular	Rectangular	Same
Maximum Output Voltage (volts)	$68V\pm20% @500\Omega$	$42V\pm10% @500\Omega$	Similar
Maximum Output Current (specify units)	$136mA\pm20% @500\Omega$	$84mA\pm10% @500\Omega$	Note 3
Pulse width (μsec)	220-230μs	100μs
Pulse Period (msec)	6.4-901ms	9.3~850ms
Max. pulse frequency (Hz) [or Rate (pps)]	1.11-155.6Hz	110Hz
Net Charge (μC per pulse)	0μC @500Ω; Method: Balanced waveform	0μC @500Ω; Method: Balanced waveform	Same
Maximum Phase Charge, (μC)	26μC@500Ω	16.8μC @500Ω	SimilarNote 4
Maximum Average Current, (mA)	5.54mA@500Ω	0.924mA
Maximum Current Density, (mA/cm², r.m.s.)	0.46mA/cm² @500Ω	0.462mA/cm²	Same
Maximum Average Power Density, (mW/cm²)	31.40mW/cm² @500Ω	9.702mW/cm²	SimilarNote 4
Biocompatibility	All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements.	All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements.	Same
Accessories	Self-adhesive electrodes, electrode wires, Battery charger, USB cable	Self-adhesive electrodes, electrode wires, Battery charger, USB cable	Same
Table 4-
Parameters	New Device	Predicate Device	Remark
510(k) Number	K201354	K121719	--
Device Name	TENS & PMS	SM TENS & PMS	--
Model	SM9196	No	--
Manufacturer	Hong Qiangxing (Shenzhen)Electronics Limited	Hong Qiangxing (Shenzhen)Electronics Limited	Same
Intended use	TENS(1015):To be used for temporary relief ofpain associated with sore and achingmuscles in the shoulder, waist, back,neck, upper extremities (arm), andlower extremities (leg) due to strainfrom exercise or normal householdwork activities.PMS(19):It is intended to be used to stimulatehealthy muscles in order to improveand facilitate muscle performance.	TENS(1,3,4,5,6):To be used for temporary relief ofpain associated with sore and achingmuscles in the shoulder, waist, back,neck, upper extremities (arm), andlower extremities (leg) due to strainfrom exercise or normal householdwork activities.PMS(1,2,3,6):It is intended to be used to stimulatehealthy muscles in order to improveand facilitate muscle performance.	Same
Type of use	OTC	OTC	Same
Power Source(s)	DC 3.7V lithium battery	DC 3.7V lithium battery	Same
- Method of LineCurrent Isolation	Type BF	Type BF	Same
- Patient LeakageCurrent	--Normal Condition (μΑ)< 10μΑSingle Fault Condition (μΑ)< 50μΑ	--< 10μΑ< 50μΑ	Same
Average DC current through electrodeswhen device is on but no pulses arebeing applied (μΑ)	< 0.01μA	< 0.01μA	Same
Number of OutputModes	15	6	SimilarNote 1
Number of Outputchannels:- Synchronousor Alternating?	4Synchronous & Alternating	2Synchronous	SimilarNote 2
- Method ofChannel Isolation	Voltage transformer Isolation	Voltage transformer Isolation
		4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126
Regulated Current orRegulated Voltage?		Voltage control	Voltage control	Same
Software/Firmware/MicroprocessorControl?		Software	Software	Same
	Automatic OverloadTrip?	No	No	Same
	Automatic No-LoadTrip?	No	No	Same
	Automatic Shut Off?	Yes	Yes	Same
UserOverrideControl?		Yes	Yes	Same
Indicator	On/OffStatus?	Yes	Yes	Same
Display	LowBattery?	Yes	Yes	Same
	Voltage/CurrentLevel?	Yes	Yes	Same
Timer(minutes)	Range	60 minutes	10 ~ 60 minutes, 10 min./step	SimilarNote 2
CompliancewithVoluntaryStandards?		Yes.AAMI/ANSI ES60601-1, IEC60601-1-2, IEC 60601-2-10, IEC62133, HA 60601-1-11	Yes.AAMI/ANSI ES60601-1, IEC60601-1-2, IEC 60601-2-10, IEC62133, IEC 60601-1-11	Same
Compliance with 21CFR 8988?		Yes	Yes	Same
Weight (grams)		$100g\pm5g$	140g	SimilarNote 1
Dimensions(mm)[W x H x D]		58mm180mm15.5mm	83429mm	SimilarNote 1
Housing Materials &Construction		ABS	ABS	Same
Waveform		Pulsed, symmetric, biphasic	Pulsed, symmetric, biphasic	Same
Shape		Rectangle	Rectangle	Same
MaximumVoltage (volts)	Output	$54V\pm20% @500\Omega$	$42V\pm10% @500\Omega$	SimilarNote 3
MaximumCurrent(specifyunits)		Output	$108mA\pm20% @500\Omega$	$84mA\pm10% @500\Omega$
Pulse width (μsec)		200-210μs	100μs
Pulse Period (msec)		20.4-620ms	9.3~850ms
Max.frequency (Hz) [orRate (pps)]	pulse	1.613-49.02Hz	110Hz
Net Charge (µC perpulse)		0µC @500Ω; Method: Balanced waveform	0µC @500Ω; Method: Balanced waveform	Same
MaximumCharge, (µC)	Phase	$17\mu C@500\Omega$	$16.8\mu C @500\Omega$	Similar
Maximum Average	Current, (mA)	1.88mA	0.924mA	SimilarNote 4
MaximumDensity,r.m.s.)	Current(mA/cm2,	$0.08mA/cm^2 @500\Omega$	$0.462mA/cm^2$
MaximumPower(mW/cm2)	AverageDensity,	$3.65mW/cm^2 @500\Omega$	$9.702mW/cm^2$
Biocompatibility		All user directly contacting materials		Same

{14}------------------------------------------------

Comparison in details:

Note 1:

The proposed device SM9186 has more treatment programs than the predicate device K121719, all treatment programs of proposed device are comparable to the mode 3 of the predicate device. The proposed device doesn't have treatment program to compare with the mode 6 of the predicate device because predicate device's mode 4 to mode 6 are variation waveform of the mode 3. All of the treatment programs have passed the IEC 60601-2-10 and AAMI / ANSI ES60601-1 test codes. So this difference doesn't raise any safety or effectiveness issue. And the weight, dimensions, appearance of proposed device SM9186 are a little different from predicate device K121719, but these differences are insignificant in the terms of safety or effectiveness.

Note 2:

Note 3:

{15}------------------------------------------------

4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126 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 passed IEC 60601-2-10 test codes. So these differences won't raise any new safety and effectiveness issues.

Note 4:

The maximum phase charge of the proposed device SM9186 is larger than that of the predicate device. Both of them have passed the IEC 60601-2-10 and AAMI / ANSI ES60601-1 test codes. The maximum average power density of proposed device is different from the predicate device due to they are calculated by different electrode area. Both of them meet maximum average power density <0.25W/cm². Therefore these differences won't raise any new safety and effectiveness issues.

Final conclusion:

The subject device SM9186 is substantial Equivalent to the predicate device K121719.

{16}------------------------------------------------

{17}------------------------------------------------

4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126

	are compliance with ISO10993-5 andISO10993-10 requirements.	are compliance with ISO10993-5 andISO10993-10 requirements.
Accessories	Self-adhesive electrodes, electrode wires, Battery charger, USB cable	Self-adhesive electrodes, electrode wires, Battery charger, USB cable	Same

Comparison in details:

Note 1:

The proposed device SM9196 has more treatment programs than the predicate device K121719, all treatment programs of proposed device are comparable to the mode 3 of the predicate device. The proposed device doesn't have treatment program to compare with the mode 6 of the predicate device because predicate device's mode 6 are variation waveform of the mode 1 to mode 3. All of the treatment programs have passed the IEC 60601-2-10 and AAMI / ANSI ES60601-1 test codes. So this difference doesn't raise any safety or effectiveness issue. And the weight, dimensions, appearance of proposed device SM9196 are a little different from predicate device K121719, but these differences are insignificant in the terms of safety or effectiveness.

Note 2:

The proposed device has 4 output channels are alternating & synchronous while the predicate device has 2 output channels and these channels are synchronous. The proposed device gives users more choices. Because 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 ES60601-1 and IEC 60601-2-10 test codes, so these differences won't raise any new safety and effectiveness issues.

Note 3:

Note 4:

The maximum current density, maximum average power density have some differences between proposed device and predicate device due to they are calculated by different electrode area. Both of them meet maximum current density <2mA/cm² and maximum average power density <0.25W/cm². Therefore these differences won't raise any new safety and effectiveness issues.

Final conclusion:

The subject device SM9196 is substantial Equivalent to the predicate device K121719.

{18}------------------------------------------------

4. Substantial Equivalence to Predicate device: Output Specifications

Table 5-SM 9079

Parameter		New Device					Predicate	New Device
Mode or program name		Program 1	Program 3	Program 4	Program 5	Program 6	Program 21	Mode 3	Program 2	Program 7	Program 8
Waveform		Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic
Shape		Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular
Maximum	@500Ω	34.4	42	34.4	34.4	40.8	40.8	42	38.4	33.6	33.6
Output Voltage	@2kΩ	58.4	83	58.4	58.4	70	70	84	65.2	56.8	56.8
(V)	@10kΩ	107	144	107	107	123	123	130	117	104	104
Maximum	@500Ω	68.8	84	68.8	68.8	81.6	81.6	84	76.8	67.2	67.2
Output Current	@2kΩ	29.2	41.5	29.2	29.2	35	35	42	32.6	28.4	28.4
(mA)	@10kΩ	10.7	14.4	10.7	10.7	12.3	12.3	13	11.7	10.4	10.4
Pulse Width(μs)		190	190	190	190	190	190	100	190	190	190
Frequency (Hz)		23.8	1.613	24.04	1.667~25.0	0.935~7.69	0.935~25	1.17	4.762	24.04	23.8
For interferential modes only:		N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
-Beat Frequency (Hz)
For multiphasic	Symmetricalphases	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
waveforms
only:	Phaseduration	190	190	190	190	190	190	100	190	190	190
Net Charge (@500Ω) [uC]		0	0	0	0	0	0	0	0	0	0
Maximum Phase Charge (uC)		11.094	13.87	11.36	11.36	13.32	13.22	16.8	12.12	11.35	11.08
Maximum Current Density (mA/cm²)		0.052	0.004	0.05	0.054	0.02	0.065	0.0049	0.0116	0.051	0.051
Maximum Power Density, (mW/cm²)		1.78	0.18	1.8	1.87	0.81	2.64	0.103	0.44	1.72	1.70
Burst Mode	(a) Pulses perburst	NA	NA	NA	NA	NA	NA	NA	17	79	49
	(b) Bursts persecond	NA	NA	NA	NA	NA	NA	NA	0.196	0.164	0.327
	(c) Burstduration(seconds)	NA	NA	NA	NA	NA	NA	NA	3.52	3.3	2.05
	(d) DutyCycle: Line(b) x Line (c)	NA	NA	NA	NA	NA	NA	NA	0.69	0.54	0.67
ON Time (seconds)		NA	NA	NA	NA	NA	NA	NA	3.52	3.3	2.05
OFF Time (seconds)		NA	NA	NA	NA	NA	NA	NA	1.58	2.79	1
Additional Features		N/A	N/A	N/A	N/A	NA	NA	N/A	N/A	N/A	N/A
Continue
ParameterNew device			Predicate	New Device
	Mode or program name		Mode 2	Program 9	Program 10	Program 11	Program 12	Program 13	Program 15	Program 16	Program 17
Waveform			Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic
Shape		Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular
Maximum	@500Ω	32.8	42	34.8	34.8	34.4	34.4	34.4	34.4	34.4	34.4
Output Voltage	@2kΩ	56	84	58.8	58.8	58.4	58.4	58.4	58.4	58.4	58.4
(V)	@10kΩ	103	130	107	107	107	107	107	107	107	107
Maximum	@500Ω	65.6	84	69.6	69.6	68.8	68.8	68.8	68.8	68.8	68.8
Output Current	@2kΩ	28	42	29.4	29.4	29.2	29.2	29.2	29.2	29.2	29.2
(mA)	@10kΩ	10.3	13	10.7	10.7	10.7	10.7	10.7	10.7	10.7	10.7
Pulse Width(us)			100	190	190	190	190	190	190	190	190
Frequency (Hz)		25	12.5~55.5	25	23.8	25	23.8	24.39	25	24.04	25
For interferential modes only:Beat Frequency (Hz)		N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
For multiphasicwaveforms	Symmetricalphases	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
only:	PhaseDuration	190	100	190	190	190	190	190	190	190	190
Net Charge (@500Ω) [uC]		0	0	0	0	0	0	0	0	0	0
Maximum Phase Charge (uC)		10.56	16.8	11.415	11.42	11.17	11.08	11.49	11.53	11.55	11.65
Maximum	CurrentDensity(mA/cm²)	0.052	0.2331	0.055	0.053	0.054	0.052	0.053	0.054	0.052	0.054
Maximum	PowerDensity,(mW/cm²)	1.70	4.895	1.92	1.83	1.87	1.78	1.83	1.87	1.8	1.87
Burst Mode	(a) Pulses perburst	130	250~1110	291	129	124	218	161	76.5	149	291
	(b) Bursts persecond	0.124	0.048	0.067	0.133	0.167	0.083	0.116	0.245	0.139	0.067
	(c) Burstduration(seconds)	5.18	20	11.62	5.4	4.96	9.14	6.62	3.06	6.2	11.64
	(d) DutyCycle: Line(b) x Line (c)	0.64	0.96	0.78	0.72	0.83	0.76	0.77	0.75	0.86	0.78
ON Time (seconds)		5.18	20	11.62	5.4	4.96	9.14	6.62	3.06	6.2	11.64
OFF Time (seconds)		2.94	1	3.24	2.12	1	2.96	1.97	1	1	3.26
Additional Features		N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Continue

{19}------------------------------------------------

Hong Qiangxing(Shen Zhen) Electronics Limited

4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126

{20}------------------------------------------------

Hong Qiangxing(Shen Zhen) Electronics Limited

4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126

Parameter	New Device						Predicated Device
Mode or program name	Program 18	Program 19	Program 20	Program 22	Program 23	Program 24	Mode 1
Waveform	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic
Shape	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular
Maximum	@500Ω	34.4	34.4	34.4	38	34.4	34.4	42
Output Voltage	@2kΩ	58.4	58.4	58.4	58.4	58.4	58.4	84

{21}------------------------------------------------

Hong Qiangxing(Shen Zhen) Electronics Limited

4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126

(V)	@10kΩ	107	107	107	115	107	107	130
Maximum	@500Ω	68.8	68.8	68.8	76	68.8	68.8	84
Output	@2kΩ	29.2	29.2	29.2	29.2	29.2	29.2	42
Current(mA)	@10kΩ	10.7	10.7	10.7	11.5	10.7	10.7	13
Pulse Width(us)		190	190	190	190	190	190	100
Frequency (Hz)		24.5	24.5	24.04	4.76~25.0	23.8	23.8	68
For interferential modes only:		N/A	N/A	N/A	N/A	N/A	N/A	N/A
-Beat Frequency (Hz)
For multiphasic	Symmetrical phases	Yes	Yes	Yes	Yes	Yes	Yes	Yes
waveforms	Phase Duration	190	190	190	190	190	190	100
only:
Net Charge (@500Ω) [uC]		0	0	0	0	0	0	0
Maximum Phase Charge (uC)		11.32	11.40	11.55	12.29	11.06	11.59	16.8
Maximum Current Density (mA/cm2)		0.053	0.053	0.052	0.06	0.052	0.052	0.2856
	Maximum Power Density, (mW/cm2)	1.84	1.84	1.8	2.29	1.78	1.78	5.998
Burst Mode	(a) Pulses per burst	141	127	208	34-179	404	415	204
	(b) Bursts per second	0.137	0.162	0.095	0.098	0.045	0.045	0.219
	(c) Burst duration (seconds)	5.76	5.17	8.66	7.14	16.98	17.44	3
	(d) Duty Cycle: Line (b) x Line (c)	0.79	0.84	0.82	0.7	0.76	0.78	0.66
	ON Time (seconds)	5.76	5.17	8.66	7.14	16.98	17.44	3
OFF Time (seconds)		1.52	1	1.96	3.02	5.41	4.78	1.56
Additional Features (specify, if applicable)		N/A	N/A	N/A	N/A	N/A	N/A	N/A

Table 6-SM 9126

Parameter	New Device						Predicate	New Device
Mode or program name	Program 1	Program 8	Program 9	Program 10	Program 13	Program 14	Mode 1	Program 2	Program 7	Program 15
Waveform	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic
Shape	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular
	@500Ω	@2kΩ	@10kΩ	@500Ω	@2kΩ	@10kΩ
MaximumOutput Voltage(V)	30.8	84	159	30.4	72.4	124	30.8	30.8	30.8	4.6
MaximumOutput Current(mA)	61.6	42	15.9	60.8	36.2	12.4	61.6	61.6	84	9.2
							42	41.2	30.4	4.6
							84	113	72.4	15.6
							159	163	123	24
							61.6	82.4	60.8	9.2
							42	56.5	36.2	7.8
							13	16.3	12.3	2.4
Pulse Width(µs)	220	220	220	220	220	220	220	100	220	220	220
Frequency (Hz)	52.08	40.98	40.98	40.98	41.67	52.63	68	9.26	38.46	57.47
For interferential modes only:-Beat Frequency (Hz)	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
For multiphasicwaveformsonly:	Symmetricalphases	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
	Phaseduration	220	220	220	220	220	220	100	220	220	220
Net Charge (@500Ω) [uC]	0	0	0	0	0	0	0	0	0	0
Maximum Phase Charge (uC)	13.7	10.5	13.7	13.7	13.7	13.7	16.8	15	10.5	1.4
Maximum Current Density(mA/cm²)	0.117	0.091	0.093	0.093	0.094	0.119	0.2856	0.03	0.09	0.019
Maximum Power Density,(mW/cm²)	3.62	2.78	2.85	2.85	2.9	3.66	5.998	1.15	5.21	0.09
Burst Mode	(a) Pulses perburst	212	520	254	127	521	216	204	34	149	488
	(b) Bursts persecond	0.17	0.061	0.12	0.230	0.0625	0.173	0.219	0.18	0.145	0.098
	(c) Burstduration(seconds)	4.07	12.7	6.21	3.09	12.48	4.1	3	3.72	3.87	8.5
Cycle: Line(b) x Line (c)
ON Time (seconds)	4.07	12.7	6.21	3.09	12.48	4.1	3	3.72	3.87	8.5
OFF Time (seconds)	1.68	3.52	2.3	1.28	3.52	1.66	1.56	1.84	2.98	1.7
Additional Features	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A

{22}------------------------------------------------

Hong Qiangxing(Shen Zhen) Electronics Limited 4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126

{23}------------------------------------------------

4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126

Continue

Parameter		Predicate	New Device						Predicate
Mode or program name		Mode 2	Program 3	Program 4	Program 5	Program 6	Program 11	Program 12	Program 16	Mode 3
Waveform		Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic
Shape		Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular
MaximumOutput Voltage	@500Ω	42	46.4	30.8	28.8	37.6	4.6	11	4.6	42
	@2kΩ	84	126	84	68	100	15.6	20.8	15.6	84
(V)	@10kΩ	130	161	159	119	153	24	37.2	24	130
MaximumOutput Current	@500Ω	84	92.8	61.6	57.6	75.2	9.2	22	9.2	84
	@2kΩ	42	63	42	34	50	7.8	10.4	7.8	42
(mA)	@10kΩ	13	16.1	15.9	11.9	15.3	2.4	3.72	2.4	13
Pulse Width(μs)		100	220	220	220	220	220	220	220	100
Frequency (Hz)		12.5~55.5	1.47	40.98	3.33~37.04	1.79~13.51	212.5	113.6	57.47	1.17
For interferential modes only:		N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Beat Frequency (Hz)
For multiphasicwaveformsonly:	SymmetricalphasesPhaseDuration	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
		100	220	220	220	220	220	220	220	100
Net Charge (@500Ω) [uC]		0	0	0	0	0	0	0	0	0
Maximum Phase Charge (uC)		16.8	17.26	13.7	10.39	14.54	2.02	4.18	2.02	16.8
Maximum Current(mA/cm²)	Density	0.2331	0.005	0.093	0.078	0.037	0.072	0.092	0.019	0.0049

{24}------------------------------------------------

Hong Qiangxing(Shen Zhen) Electronics Limited

and the contraction of the comments of the contraction of the contribution of the contribution of the contribution of the contribution of the contribution of the contribution4F,Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126

4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126
Maximum	Power Density(mW/cm²)	4.895	0.23	2.85	2.25	1.4	0.33	1.01	0.09	0.103
Burst Mode	(a) Pulses per burst	250~1110	NA	NA	NA	NA	NA	NA	NA	NA
	(b) Bursts per second	0.048	NA	NA	NA	NA	NA	NA	NA	NA
	(c) Burst duration(seconds)	20	NA	NA	NA	NA	NA	NA	NA	NA
	(d) Duty Cycle:Line (b) x Line (c)	0.96	NA	NA	NA	NA	NA	NA	NA	NA
ON Time (seconds)		20	NA	NA	NA	NA	NA	NA	NA	NA
OFF Time (seconds)		1	NA	NA	NA	NA	NA	NA	NA	NA
Additional Features		N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A

Table 7-SM 9186

Parameter	New Device				Predicate	New Device			Predicate	New Device
Mode or program name	Program 1	Program 6	Program 9	Program 12	Mode 1	Program 2	Program 5	Program 10	Mode 2	Program 3
Waveform	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic
Shape	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular
Maximum @500Ω	43.8	48	38.4	42.4	42	43.8	36.8	7	42	63
Output @2kΩ	57	74	59.6	76	84	81	66	13.1	84	116
Voltage (V) @10kΩ	142	156	109	152	130	149	126	24.2	130	149
Maximum @500Ω	87.6	96	76.8	84.8	84	87.6	73.6	14	84	126
Output @2kΩ	28.5	37	29.8	38	42	40.5	33	6.55	42	58
Current @10kΩ (mA)	14.2	15.6	10.9	15.2	13	14.9	12.6	2.42	13	14.9

{25}------------------------------------------------

Hong Qiangxing(Shen Zhen) Electronics Limited

4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126

Frequency (Hz)	For interferential modes only:-Beat Frequency (Hz)	SymmetricalphasesPhaseduration	Net Charge (@500Ω) [uC]	Maximum Phase Charge (uC)	Maximum Current Density (mA/cm²)	Maximum Power Density, (mW/cm²)	(a) Pulses per burst	(b) Bursts per second	(c) Burst duration (seconds)	(d) Duty Cycle: Line (b) x Line (c)	ON Time (seconds)	220	220	230	220μs	100	220	220	230	100	224
31.25-58.82	N/A	Yes					212	0.186	3.6	0.67	3.6	32.26~58.82	34.48~58.82	37.03~59.52	68	N/A	8.33~52.63	92.59	155.6	12.5~55.5	1.11
			0	16.7	0.19	8.28	1200	0.034	20.4	0.7	20.4					N/A	N/A	N/A	N/A	N/A	N/A
			0	14.5	0.21	9.94	711	0.064	12.08	0.77	12.08					N/A	N/A	N/A	N/A	N/A	N/A
			0	14.5	0.17	6.65	333	0.125	5.6	0.7	5.6					N/A	N/A	N/A	N/A	N/A	N/A
			0	15.2	0.185	7.85	204	0.219	3	0.66	3					N/A	N/A	N/A	N/A	N/A	N/A
			0	16.8	0.2856	5.998	2253	0.023	42.8	0.98	42.8					N/A	N/A	N/A	N/A	N/A	N/A
			0	16.7	0.17	7.4	1639	0.04	17.7	0.73	17.7					N/A	N/A	N/A	N/A	N/A	N/A
			0	15.1	0.25	9.2	1556	0.085	10	0.85	10					N/A	N/A	N/A	N/A	N/A	N/A
			0	2.6	0.084	0.58	250~1110	0.048	20	0.96	20					N/A	N/A	N/A	N/A	N/A	N/A
			0	16.8	0.2331	4.895	N/A	N/A	N/A	N/A	N/A					N/A	N/A	N/A	N/A	N/A	N/A
			0	25.07	0.005	0.33	N/A	N/A	N/A	N/A	N/A					N/A	N/A	N/A	N/A	N/A	N/A

{26}------------------------------------------------

Hong Qiangxing(Shen Zhen) Electronics Limited

4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126

OFF Time (seconds)	1.8	8.6	3.6	2.4	1.56	1	6.5	1.76	1	N/A
Additional Features	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Continue
Parameter						New Device			Predicate
Mode or program name	Program 4	Program 7	Program 8	Program 11	Mode 3
Waveform	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic
Shape	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular
Maximum Output Voltage (V)	@500Ω43.8	@2kΩ66	@10kΩ128	@500Ω59	@2kΩ94	@10kΩ168	@500Ω68	@2kΩ117	@10kΩ174	@500Ω26.8	@2kΩ44	@10kΩ80	@500Ω42	@2kΩ84	@10kΩ130
Maximum Output Current(mA)	@500Ω76	@2kΩ33	@10kΩ12.8	@500Ω118	@2kΩ47	@10kΩ16.8	@500Ω136	@2kΩ58.5	@10kΩ17.4	@500Ω53.6	@2kΩ22	@10kΩ8	@500Ω84	@2kΩ42	@10kΩ13
Pulse Width(μs)	220	220	220	220	100
Frequency (Hz)	50~92.59	1.136~59.52	1.11~92.59	92.59	1.17
For interferential modes only: -Beat Frequency (Hz)	N/A	N/A	N/A	N/A	N/A
For multiphasic waveforms only:	Symmetrical phasesYes	Phase Duration220	Yes220	Yes220	Yes220	Yes100
Net Charge (@500Ω) [uC]	0	0	0	0	0
Maximum Phase Charge (uC)	16.72	21.5	26	9.8	16.8
Maximum Current Density (mA/cm²)	0.258	0.26	0.46	0.182	0.0049
Maximum Power Density, (mW/cm²)	9.8	15.19	31.4	4.88	0.103
Burst Mode	(a) Pulses per burstN/A	(b) Bursts per secondN/A	(c) Burst duration (seconds)N/A	(d) Duty Cycle: Line (b) x Line (c)N/A	N/A
ON Time (seconds)	N/A	N/A	N/A	N/A	N/A
OFF Time (seconds)	N/A	N/A	N/A	N/A	N/A

{27}------------------------------------------------

4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126

Additional Features (specify, if applicable)	N/A	N/A	N/A	N/A	N/A
----------------------------------------------	-----	-----	-----	-----	-----

Table 8-SM 9196

Parameter		New Device							Predicate	New Device
Mode or program name		Program 1	Program 2	Program 3	Program 4	Program 6	Program 7	Mode 1	Program 5	Program 8	Program 9
Waveform		Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic
Shape		Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular
MaximumOutput Voltage(V)	@500Ω	49.2	48	48	42.8	48	47.2	42	46	52.4	50
	@2kΩ	73.6	73.6	74	72.8	74.4	72.8	84	71.6	78.8	101
	@10kΩ	118	124	123	120	120	120	130	119	129	133
MaximumOutput Current(mA)	@500Ω	98.4	96	96	85.6	96	94.4	84	92	104.8	100
	@2kΩ	36.8	36.8	37	36.4	37.2	36.4	42	35.8	39.4	50.5
	@10kΩ	11.8	12.4	12.3	12	12	12	13	11.9	12.9	13.3
Pulse Width(us)		200	200	200	200	200	200	100	200	200	210
Frequency (Hz)		47.17	47.62	47.17	48.08	49.02	48.08	68	48.08	9.434	1.613
For interferential modes only:-Beat Frequency (Hz)		N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
For multiphasicwaveformsonly:	Symmetricalphases	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
	Phaseduration	200	200	200	200	200	200	100	200	200	210
Net Charge (@500Ω) [uC]		0	0	0	0	0	0	0	0	0	0
Maximum Phase Charge (uC)		15.84	15.20	15.20	14.5	15.20	14.8	16.8	14.6	16.48	16.8
MaximumCurrent(mA/cm²)	Density	0.07	0.07	0.073	0.07	0.08	0.07	0.2856	0.07	0.02	0.0027

MaximumPower(mW/cm²)	Density	3.65	3.51	3.48	2.82	3.61	3.43	5.998	3.26	0.83	0.14

{28}------------------------------------------------

Hong Qiangxing(Shen Zhen) Electronics Limited

4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126

Burst Mode	(a) Pulses per burst	257	238	434	303	152	173.1	204	249.1	33.4	7.74
	(b) Bursts per second	0.132	0.166	0.082	0.12	0.244	0.2	0.219	0.122	0.194	0.16
	(c) Burst duration (seconds)	5.44	5	9.2	6.3	3.1	3.6	3	5.18	3.54	4.8
	(d) Duty Cycle: Line (b) x Line (c)	0.72	0.83	0.75	0.76	0.76	0.71	0.66	0.63	0.69	0.76
ON Time (seconds)		5.44	5	9.2	6.3	3.1	3.6	3	5.18	3.54	4.8
OFF Time (seconds)		2.14	1.02	3	2	1	1.5	1.56	3	1.62	1.5
Additional Features		N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A

Continue

Parameter		Predicate	New Device						Predicate
Mode or program name		Mode 2	Program 10	Program 11	Program 12	Program 13	Program 14	Program 15	Mode 3
Waveform		Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic
Shape		Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Rectangular
Maximum	@500Ω	42	45.6	46	54	47.2	46.4	46	42
Output	@2kΩ	84	72	72	87.6	73.6	70.4	73.6	84
Voltage (V)	@10kΩ	130	112	118	131	119	117	124	130
Maximum	@500Ω	84	91.2	92	108	94.4	92.8	92	84
Output	@2kΩ	42	36	36	43.8	36.8	35.2	36.8	42
Current(mA)	@10kΩ	13	11.2	11.8	13.1	11.9	11.7	12.4	13
Pulse Width(us)		100	210	200	200	200	200	210	100
Frequency (Hz)		12.5~55.5	49.02	3.33~47.62	1.887~15.63	48.08	48.08	47.17	1.17
For interferential modes only: -Beat Frequency		N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
(Hz)

{29}------------------------------------------------

Hong Qiangxing(Shen Zhen) Electronics Limited

4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126

Formultiphasicwaveformsonly:	Symmetrical phases	Yes	Yes	Yes	Yes	Yes	Yes	Yes
	Phase Duration	100	210	200	200	200	200	210	100
	Net Charge (@500Ω) [uC]	0	0	0	0	0	0	0	0
Maximum Phase Charge (uC)		16.8	13.6	14.6	17.0	14.8	14.9	15.9	16.8
Maximum Current Density (mA/cm²)		0.2331	0.08	0.07	0.03	0.07	0.07	0.07	0.0049
Maximum Power Density, (mW/cm²)		4.895	3.42	3.22	1.46	3.43	3.31	3.35	0.103
Burst Mode	(a) Pulses per burst	250~1110	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	(b) Bursts per second	0.048	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	(c) Burst duration (seconds)	20	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	(d) Duty Cycle: Line (b) x Line (c)	0.96	N/A	N/A	N/A	N/A	N/A	N/A	N/A
ON Time (seconds)		20	N/A	N/A	N/A	N/A	N/A	N/A	N/A
OFF Time (seconds)		1	N/A	N/A	N/A	N/A	N/A	N/A	N/A
	Additional Features (specify, if applicable)	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A

{30}------------------------------------------------

4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126

5. Test summary:

TENS & PMS are safe and effective as the predicate devices cited above. The new devices have passed testings according to the following 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)]:
ANSI AAMI HA60601-1-11 2015 Medical Electrical Equipment -- Part 1-11: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment (IEC 60601-1-11:2015 MOD);

The conclusion drawn from the testings are that the new devices are 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

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).