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

Device Description

SM TENS & PMS is a portable and DC 3.7V battery powered multi function device, offering both Transcutancous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities in one device. SM TENS & PMS has 6 operation modes, which can give certain electrical pulses through electrode adhesive pads to the suggested area of the body where the electrodes are placed. The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key, Intensity Modification keys, Timing key, Pause key, Output socket, and USB port for battery charging. The display screen can show battery power, selected mode, current intensity, time remaining of an application mode, and indication of a pause. The device is equipped with accessories of electrode pads, electrode cables, battery chargers, and USB cables. 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 by special person. The electrodes are interchangeable. The application area of electrode pads must be larger than 4cm². The electrode pads are provided by GMDASZ Manufacturing Co., Ltd. with 510(k) cleared Number K092546.

AI/ML Overview

This submission is for a Traditional 510(k) for a new device, the "SM TENS & PMS" from Hong Qiangxing (Shen Zhen) Electronics Limited. The device is a portable, battery-powered multi-function device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) functionalities. The 510(k) submission seeks to demonstrate substantial equivalence to a predicate device, the "Powered Muscle Stimulator, JQ-5C" (K102598).

The acceptance criteria are established through a comparison of the new device's technical characteristics and performance against the predicate device and relevant safety standards. The study proving the device meets the acceptance criteria is a safety testing protocol, which demonstrates compliance with recognized electrical and medical device standards.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria, for the purpose of a 510(k) for substantial equivalence, are primarily that the new device performs equivalently to the predicate device in its intended use and meets relevant safety standards, without raising new questions of safety or effectiveness. The reported device performance is based on the results of the safety testing.

Acceptance Criteria Category	Specific Acceptance Criteria (Derived from comparison to predicate and standards)	Reported Device Performance
Intended Use	Identical indications for use as the predicate device (TENS for temporary pain relief, PMS for muscle performance improvement).	Met: Both SM TENS & PMS and the predicate (JQ-5C) have identical TENS and PMS indications for use.
Technological Characteristics	Similar design, power source, number of output modes, number of output channels, synchronization, channel isolation method, timer range, waveform, and wave shape.	Met: The new device is reported to have the same intended use, power supply, components, 6 modes, 2 channels, software control, standards compliance, same waveform and wave shape, same pulse width, and net charge.
Electrical Safety	Compliance with IEC 60601-1 (General Safety), IEC 60601-2-10 (Nerve and Muscle Stimulators), and IEC 60601-1-2 (EMC).	Met: The new device passed testing according to IEC 60601-1: 2005, IEC 60601-2-10: 2001, and IEC 60601-1-2: 2001.
Battery Safety	Compliance with IEC 62133 (Secondary cells and batteries safety).	Met: The new device passed testing according to IEC 62133: 2002.
Electromagnetic Compatibility (EMC)	Compliance with FCC 47 CFR Part 18 (Industrial, Scientific, and Medical Equipment - Conducted Emissions).	Met: The new device passed testing according to FCC 47 CFR Part 18.
Output Parameters (Key electrical characteristics - variations within acceptable limits)	Maximum Output Voltage, Maximum Output Current, Pulse Width, Max. Pulse Frequency, Net Charge, Maximum Phase Charge, Maximum Average Current, Maximum Current Density, Maximum Average Power Density to be comparable or safer than predicate.	Met/Compared: While some specific numerical values differ (e.g., Maximum Output Voltage and Current, Max. Pulse Frequency, Maximum Current Density, Maximum Average Power Density), the submission concludes these differences (and those attributable to different smallest surface area of electrodes) do not raise new safety or effectiveness issues. Net charge and pulse width are the same.
Patient Leakage Current	Normal Condition: ≤ 2μA; Single Fault Condition: < 10μA.	Met: Reported as 2μA (Normal Condition) and < 10μA (Single Fault Condition).
Average DC current through electrodes	< 0.01 μA when device is on but no pulses are applied.	Met: Reported as < 0.01 μA.
Electrode Pads	Electrode pads must be larger than 4cm². (Note: This is a design requirement rather than a performance criterion for the device itself).	Met: The application area of electrode pads must be larger than 4cm². The electrode pads are provided by GMDASZ Manufacturing Co., Ltd. with 510(k) cleared Number K092546.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a "test set" in the context of clinical data for the device. The evaluation is based on engineering testing of a single device (or set of devices sufficient for engineering tests) to verify compliance with standards and comparison to the predicate device's specifications. It is a technical submission, not a clinical trial.
Data Provenance: The data primarily comes from engineering and bench testing conducted by the manufacturer (Hong Qiangxing (Shen Zhen) Electronics Limited), likely performed in China (Shenzhen, Guangdong, China), where the manufacturer is located. This is a retrospective comparison to existing standards and predicate device specifications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information is not applicable to this 510(k) submission. A 510(k) for an electrical stimulator device like this does not typically involve expert review for ground truth in a clinical sense. The "ground truth" here is compliance with established electrical safety and performance standards, as well as functional equivalence to a legally marketed predicate device. This is assessed through objective engineering tests.

4. Adjudication Method for the Test Set

This is not applicable. There is no "test set" requiring adjudication by experts in the context of this 510(k) submission. The evaluation is against objective engineering standards and a comparative analysis of technical specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices or other technologies where human interpretation or clinical effectiveness is a primary endpoint requiring comparison between different readers or technologies. For TENS/PMS devices seeking substantial equivalence, such studies are not usually required in a 510(k) submission; the focus is on safety and functional equivalence to the predicate.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This concept is not applicable to the "SM TENS & PMS" device. This is a direct electrical stimulation device; it does not involve algorithms that perform diagnostic or interpretative functions that would require a "standalone" performance evaluation in the way imaging AI algorithms do. Its performance is evaluated by its electrical output characteristics and safety.

7. The Type of Ground Truth Used

The "ground truth" in this context is compliance with recognized electrical safety and performance standards (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 62133, FCC 47 CFR Part 18) and technical specifications of the predicate device. There is no "pathology" or "outcomes data" ground truth as this is not a diagnostic or treatment outcome effectiveness study.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI that would require a "training set." The submission describes a hardware device not an AI algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary

{0}------------------------------------------------

l long Qiangxing (Shen Zhen) Electronics Limited 4F. Jingcheng Building. Xicheng Industrial Zone. Xixiang Road. Bao an District. Shenzhen. Guangdong. China

Tcl: 86-755 26423605 / Url: www.sunmas.hk

Section 5 510(k) Summary [As required by 21 CFR 807.92]

Submission Information:

Type of 510(k) Submission:

Basis for 510(k) Submission:

Submitter/Manufacturer:

510(k) Number:

Date:

Contactor:

·K121719 October 23td, 2012 Traditional New device Hong Qiangxing (Shen Zhen) Electronics Limited 4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126 Doris Dong [Consultant, from Shanghai CV Technology Co., Ltd.] Add .: Room 1706 Yuesha, No. 128 Songle Rd., Songjiang, Shanghai, China 201600 E-mail: doris_d@l26.com Tel: 86 21-31261348 Fax: 86 21-37824346

Device Description: Proprietary Name: Common Name: . Classification Name:

Regulation Number: Product Code: Device Class: Review Panel: Device Description:

TENS & PMS Stimulator, nerve, transcutaneous, over-the-counter, Stimulator, muscle, powered, for muscle conditioning 882.5890. 890.5850 NUH, NGX II

Neurology & Physical Medicine

SM TENS & PMS

SM TENS & PMS has 6 operation modes, which can give certain electrical pulses through electrode adhesive pads to the suggested area of the body where the electrodes are placed.

The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key, Intensity Modification keys, Timing key, Pause key, Output socket, and USB port for battery charging

The display screen can show battery power, selected mode, current intensity, time remaining of an application mode, and indication of a pause.

The device is equipped with accessories of electrode pads, electrode cables, battery chargers, and USB cables. 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 by special

MAY 1 0 2013

{1}------------------------------------------------

Hong Qiangxing (Shen Zhen) Electronics Limited

Hong Qiangxing (Shen Zhen) Electronics Limited
4ti, Jingsteng Building, Xicheng Industrial Zone, Xixiang Road, Bao' an District, Shenzhen, Ghangdong. China
Tel: 86-755 264

Indications for use:	person.The electrodes are interchangeable. The application area of electrode padsmust be larger than 4cm². The electrode pads are provided by GMDASZManufacturing Co., Ltd. with 510(k) cleared Number K092546.TENS: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:It is intended to be used to stimulate healthy muscles in order to improve
----------------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Indications for use:

person.The electrodes are interchangeable. The application area of electrode padsmust be larger than 4cm². The electrode pads are provided by GMDASZManufacturing Co., Ltd. with 510(k) cleared Number K092546.TENS: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:It is intended to be used to stimulate healthy muscles in order to improve

----------------------

----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

3. Substantial Equivalence to Predicate device:

Detailed comparison data is included in "Section 9 - Substantial Equivalence Discussion" of this 510(k) submission. .

and facilitate muscle performance.

Parameters		New Device	Predicate Device
1.	510(k) Number	K121719	K102598
2.	Marketing clearance date:	-	May 13, 2011
3.	Device Name	SM TENS & PMS	Powered Muscle Stimulator, JQ-SC
4.	Manufacturer	Hong Qiangxing (Shenzhen) ElectronicsLimited	Hi-Dow International, Inc.
5.	Accessories	Self-adhesive electrodes, electrode wires.	Self-adhesive electrodes, electrode wires,
		Battery charger, USB cable.	Battery charger, USB cable
6.	Intended use	TENS (Mode 1, 3, 4, 5, 6):	TENS (Mode 1. 3. 4. 5. 6):
		To be used for temporary relief of pain	To be used for temporary relief of pain
		associated with sore and aching muscles in	associated with sore and aching muscles
		the shoulder, waist, back, neck, upper	in the shoulder, waist, back, neck, upper
		extremities (arm), and lower extremities	extremities (arm), and lower extremities
		(leg) due to strain from exercise or normal	(leg) due to strain from exercise or
		household work activities.	normal household work activities.
		PMS (Mode 1, 2, 3, 6):	PMS (Mode 1, 2, 3, 6):
		It is intended to be used to stimulate healthy	It is intended to be used to stimulate
		muscles in order to improve and facilitate	healthy muscles in order to improve and
		muscle performance.	facilitate muscle performance.
7.	Power Source(s)	DC 3.7V lithium battery	DC 3.7V lithium battery
	- Method of Line Current	Type BF	Type BF
	Isolation
	- Patient Leakage Current	-	-
	- Normal Condition	2μA	2μA
	- Single Fault	< 10μA	< 10μA
	Condition
8.	Average DC current	< 0.01 μA	< 0.01 μA
	through electrodes when
	Tel: 86-755 26423605 / Url: www.sunmas.hk
	device is on but no pulsesare being applied (µA)
9.	Number of Output Modes	6	6
10.	Number of Outputchannels:	2	2
	- Synchronous orAlternating?	Synchronous	Synchronous
	- Method of ChannelIsolation	Voltage transformer Isolation	Voltage transformer Isolation
11.	Timer Range (minutes)	10 - 60 minutes, 10 min./step	10 - 60 minutes, 10 min./step
12.	Compliance with VoluntaryStandards?	IEC 60601-1, IEC 60601-1-2,IEC 60601-2-10, IEC 62133,FCC 47 CFR Part 18	IEC 60601-1, IEC 60601-1-2,IEC 60601-2-10
13.	Waveform	Pulsed, symmetric, biphasic	Pulsed, symmetric, biphasic
14.	Shape	Rectangular, with interphase interval,	Rectangular, with interphase interval
15.	Maximum Output Voltage(volts)	$42V±10% @500Ω$$84V±10% @2kΩ$$130V±10% @10kΩ$	$62.4V @500Ω$$76V @2KΩ$$84V @10KΩ$
16.	Maximum Output Current(specify units)	$84mA±10% @500Ω$$42mA±10% @2KΩ$$13mA±10% @10KΩ$	$124.8mA @500Ω$$38mA @2KΩ$$8.4mA @10KΩ$
17.	Pulse width (µsec)	100µs	100µs
18.	Max. pulse frequency (Hz)	110Hz	61.3Hz
19.	Net Charge (µC per pulse)	0µC @500Ω; Method: Balanced waveform	0µC @500Ω; Method: Balancedwaveform
20.	Maximum Phase Charge,(µC)	16.8µC @500Ω	17.92µC @500Ω
21.	Maximum Average Current,(mA)	0.924mA @500Ω	1.248mA @500Ω
22.	Maximum Current Density,(mA/cm², r.m.s )	0.462mA/cm² @500Ω	9.92mA/cm² @500Ω
23.	Maximum Average PowerDensity. (W/cm³)	9.702mW/cm² @500Ω	2.72mW/cm²@500Ω
	Similarities between New deviceand Predicate Device:	Same intended use, power supply, components, 6 modes, 2 channels, software controlled,standards, same waveform and wave shape, same pulse width, net charge, similar phasecharge and maximum average current
	Differences between New deviceand Predicate Device:	Different weight and dimensions, different values of Maximum Average Power Densitybecause of different smallest surface area of electrodes;The new device provides safety test report on battery
Conclusion:		The SM TENS & PMS is substantially equivalent to the Powered Muscle Stimulator,JQ-5C (K102598). This conclusion is based upon comparison on design, technicalcharacteristics, output mode, intended use, and safety standards complied with. Anydifferences in the technological characteristics do not raise any new safety andeffectiveness issues.

2-4

{2}------------------------------------------------

Hong Qiangxing (Shen Zhen) Electronics Limited

l l one Qiangxing (Shen Zhen) Electronics Limited
4F. Jingcheng Building. Xicheng Industrial Zone. Xixiang Roud. Bao'an District. Shenzhen, Guangdong. China
Tel: 86-755 264

3-4

{3}------------------------------------------------

Hong Qiangxing (Shen Zhen) Electronics Limited

4F. Jingcheng Building, Xicheng Industrial Zone. Xixiang Road, Bao'an District, Shenzhen, Guangdong, China Tel: 86-755 26423605 / Url: www.sunmas.hk

4. Safety and Effectiveness of the device:

SM TENS & PMS is safe and effective as the predicate devices cited above.

The new device has passed testing according to the safety standards:

IEC 60601-1: 2005, Medical Electrical Equipment - Part 1: General Requirements for Safety 2) IEC 60601-2-10: 2001, Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators;
IEC 60601-1-2: 2001, Medical Electrical Equipment - Part 1-2: General Requirements for Safety -

Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests;

IEC 62133: 2002, 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
FCC 47 CFR Part 18 Telecommunication: Industrial, Scientific, and Medical Equipment; Conducted Emissions

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.

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

May 14,2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Hong Qiangxing (Shen Zhen) Electronics Limited % Shanghai CV Technology Co., Ltd. Attn: Ms. Doris Dong Room 1706 Yuesha, No. 128 Songle Rd., Songjiang Area Shanghai, 201600 China

Re: K121719

Trade/Device Name: SM TENS & PMS Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX, NUH Dated: April 24, 2013 Received: May 1, 2013

Dear Ms. Dong:

This letter corrects our substantially equivalent letter of May 10, 2013.

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. 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 statutes and regulations administered by other Federal agencies. You must

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

Page 2 - Ms. Doris Dong

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also. please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Section 4 Indications for Use Statement

510(k) Number (if known):

Device Name: SM TENS & PMS

Indications for Use:

TENS:

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:

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

Prescription Use_ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use __ J (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Joyce M. Whang -S
(Division Sign Off)

Division of Neurological and Physical Medicine Devices (DNPMD)

K121719 510(k) Number

Page 1 of 1

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).