TENS: This mode is designed 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.

EMS: This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

R-E1 EMS Stimulator

This device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

R-T1 TENS Stimulator

This device is designed 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.

Device Description

The RW Series A Electrical Stimulators, which includes models R-C1 TENS and EMS stimulator, R-E1 EMS stimulator and R-T1 TENS stimulator, are Transcutaneous Electrical Nerve Stimulator and muscle stimulator for pain relief and/or Electrical Muscle Stimulator. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of units are controlled by the press buttons. Its intensity level is adjustable according to the needs of patients.

The device unit of R-C1 was portable device, battery powered (6.0V DC) multi-function device offering both Transcutaneous Electrical Nerve Stimulator(TENS) and Powered Muscle Stimulator (EMS) qualities in one device.

The electrode size is 50*50mm, the manufacturer is Top-Rank Health care Equipment Co., Ltd. The electrode is OTC use and cleared with 510(K), the cleared number is K132588. It has been evaluated and tested according to ISO 10993-1/-5 and -10 standards.

The three models of R-C1, R-E1 and R-T1 have the same appearance, structure, display, electrical principle and CDF, the main differences are software and color. The R-C1 have TENS mode (18 programs), EMS mode (15 programs). The R-E1 only have EMS mode (15 programs) and R-T1 only have TENS mode (18 programs). The R-C1 was combination the function of R-E1 and R-T1.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device (Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator). It describes the device, its intended use, comparison to predicate devices, and non-clinical testing performed to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

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

The document provides a table outlining compliance with recognized consensus standards for safety and performance (page 6). This effectively acts as the acceptance criteria for the non-clinical tests.

Item	Description	FDA recognized consensus standards	Reported Device Performance
Safety	IEC 60601-1:2005+A1:2012	Yes	Conform
EMC	IEC 60601-1-2:2014	Yes	Conform
Home healthcare environment	IEC 60601-1-11:2015	Yes	Conform
Performance	IEC 60601-2-10:2012+A1:2016	Yes	Conform
Software	IEC 62304:2006	Yes	Conform
Usability	IEC 62366-1:2015	(Blank)	(Blank)
Risk management	ISO 14971:2007	Yes	Conform

The document also provides a detailed comparison table (pages 8-9) with the predicate devices for various technical characteristics. For each characteristic, the comparison indicates "Same," "Different but does not adversely impact safety and effectiveness," or similar justifications, implying that these characteristics meet the acceptance criteria established by the predicate devices or are otherwise deemed safe and effective. Specific numerical values are provided for many parameters, such as maximum output voltage, maximum output current, pulse width range, and frequency.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." (page 6). The evaluation was based solely on non-clinical (laboratory) testing. Therefore, there is no sample size for an effectiveness test set, nor is there data provenance in the context of clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since no clinical studies were performed and the substantial equivalence determination was based on non-clinical, laboratory testing and comparison to predicate devices, this information is not applicable. The "ground truth" for the device's acceptable performance was established by demonstrating compliance with recognized safety and performance standards (e.g., IEC standards) and showing equivalence to legally marketed predicate devices through technical specifications and testing.

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

Not applicable, as no clinical test set requiring expert adjudication was used.

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

Not applicable. The device is an electrical stimulator, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.

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

Not applicable. The device is an electrical stimulator, not an algorithm. However, the non-clinical tests (e.g., electrical safety, performance, software validation) represent an evaluation of the device's standalone performance against established engineering and safety standards.

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

For this device, the "ground truth" for demonstrating safety and effectiveness was based on:

Compliance with recognized international consensus standards: Such as IEC 60601 series, ISO 14971, and IEC 62304. These standards define the acceptable performance and safety characteristics for medical electrical equipment.
Comparison to legally marketed predicate devices: The predicate devices (MT9001, LT3060; K130802) serve as the established "ground truth" for a device of this type being safe and effective for its indicated use. The extensive comparison table (pages 8-9) outlines how the new device's technical specifications either match or differ in ways that do not adversely impact safety and effectiveness compared to these predicates.

8. The sample size for the training set

Not applicable. The device is an electrical stimulator that performs physical functions, not a machine learning model that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

June 7, 2018

Shenzhen Roundwhale Technology Co., Ltd. Kevin Zhang General Manager No. 615, Building C of Sanlian Industrial Zone, Shiyan, Baoan District Shenzhen, GuangDong, CN 518108

Re: K180956

Trade/Device Name: Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: February 9, 2018 Received: April 12, 2018

Dear Kevin Zhang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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 comply with all the Act's

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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); 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.

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Vivek J. Pinto -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180956

Device Name

Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator

Indications for Use (Describe)

R-C1 TENS and EMS Stimulator

EMS: This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

R-E1 EMS Stimulator

This device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

R-T1 TENS Stimulator

Type of Use (Select one or both, as applicable)

Research Use Only (Part 301 CFR 301.3: Select One)	For In-Vitro Use Only (Part 301 CFR 301.3: Select One)
------------------------------------------------------------------------------------------	----------------------------------------------------------------------------------------------------------------

| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Sponsor: Shenzhen Roundwhale Technology Co., Ltd File No: RW-Stimulator A-FDA-8 Date: Jun. 6, 2018

510(k) SUMMARY

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92.

The assigned 510(k) number is: K180956

1. Information of Submitter and Correspondent

Submitter's information:

Company Name:	Shenzhen Roundwhale Technology Co., Ltd
Street Address:	No. 615, Building C of Sanlian Industrial Zone, Shiyan, Baoan District
City:	Shenzhen
State/ Province:	Guangdong
Country:	China
Telephone:	+86(755) 23212776
Fax:	+86(755) 23212776
Contact Person:	Kevin Zhang
Contact Title:	General Manager
Contact Email:	info@yjing.net

Submission correspondent's information:

Shenzhen Reanny Medical Devices Management Consulting Co., Ltd

Address: Room 2012#, Gebu commercial building, Hongxing community, Songgang street, Baoan district, Shenzhen 518000, China

Contact Person: Reanny Wang; E-mail: reanny@reanny.com

2. Device Information

a) Trade Name: R-C1, TENS and EMS Stimulator Common Name: Electro-Stimulator or Electrical Stimulator

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Classification Name:	Stimulator, Muscle, Powered, for muscle conditioningper 21 CFR § 890.5850;Transcutaneous Electrical Nerve Stimulator for Pain Relief;Stimulator, Nerve, Transcutaneous, Over-the-Counterper 21 CFR § 882.5890
Device Class:	Class II
Product Code:	NUH, NGX
b) Trade Name:	R-E1, EMS Stimulator
Common Name:	Powered Muscle Stimulator, OTC
Classification Name:	Stimulator, Muscle, Powered, for muscle conditioningper 21 CFR § 890.5850;
Device Class:	Class II
Product Code:	NGX
c) Trade Name:	R-T1, TENS Stimulator
Common Name:	TENS or TENS Device
Classification Name:	Transcutaneous Electrical Nerve Stimulator for Pain Relief;Stimulator, Nerve, Transcutaneous, Over-the-Counterper 21 CFR § 882.5890
Device Class:	Class II
Product Code:	NUH

3. Identification of Predicate Device(s)

Manufacturer	Shenzhen Dongdixin Technology Co., Ltd
Legally Marketed Device	MT9001, LT3060
510 (K) Number	K130802

4. Description of Device

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by the press buttons. Its intensity level is adjustable according to the needs of patients.

5. Intended Use

R-C1, TENS and EMS Stimulator

For TENS mode

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.

For EMS mode

To be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

R-E1, EMS Stimulator

To be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

R-T1, TENS Stimulator

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6. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

6.1 Non-clinical testing

A series of safety and performance tests were conducted on the subject device, RW series A Electrical stimulators (Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator and model R-T1 TENS Stimulator).

Shelf life
Software validation
Electromagnetic compatibility and electrical safety
Function test

All the test results demonstrate RW series A Electrical stimulators (Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator and model R-T1 TENS Stimulator) meets the requirements of its pre-defined acceptance criteria and intended uses, and is substantially equivalent to the predicate devices.

6.2 Clinical Testing

No clinical test data was used to support the decision of substantial equivalence.

7. Performance Summary

Item	Description	FDA recognizedconsensusstandards	Justification
Safety	IEC 60601-1:2005+A1:2012	Yes	Conform
EMC	IEC 60601-1-2:2014	Yes	Conform
Home healthcareenvironment	IEC 60601-1-11:2015	Yes	Conform
Performance	IEC 60601-2-10:2012+A1:2016	Yes	Conform
Software	IEC 62304:2006	Yes	Conform
Usability	IEC 62366-1:2015
Risk management	ISO 14971:2007	Yes	Conform

The devices conform to applicable standards as follow table:

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8. Comparison for Predicate Device & Subject Device

The RW series A Electrical stimulators (Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator and model R-T1 TENS Stimulator) submitted in this 510(k) file is substantially equivalent in intended use, design, technology/ principles of operation, materials and performance to the cleared OTC Electrical stimulator models MT9001, LT3060 (K130802). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.

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Comparisonitem	New device			Predicate device		Substantialequivalencedetermination
	R-C1TENS and EMSStimulator	R-E1 EMSStimulator	R-T1 TENSStimulator	MT9001	LT3060
510K#		Pending		K130802		N/A
Manufacturer		Shenzhen Roundwhale Technology Co., Ltd.			Shenzhen Dongdixin Technology Co., Ltd		N/A
Intended use	For TENS: This mode isdesigned to be used fortemporary relief of painassociated with sore andaching muscles in theshoulder, waist, back,neck, upper extremities(arm), and lowerextremities (leg) due tostrain from exercise ornormal household workactivities.For EMS: This mode isdesigned to be used forstimulate healthymuscles in order toimprove and facilitatemuscle performance.	This device isdesigned to beused forstimulatehealthy musclesin order toimprove andfacilitate muscleperformance.	This device isdesigned to beused fortemporary reliefof painassociated withsore andaching musclesin the shoulder,waist, back,neck, upperextremities(arm), and lowerextremities (leg)due to strainfrom exercise ornormalhousehold workactivities.	For TENS: This mode isdesigned to be used fortemporary relief of painassociated with sore andaching muscles in theshoulder, waist, back,neck, upper extremities(arm), and lowerextremities (leg) due tostrain from exercise ornormal household workactivities.For EMS: This mode isdesigned to be used forstimulate healthy musclesin order to improve andfacilitate muscleperformance.	The device isdesigned to beused fortemporary reliefof painassociated withsore and achingmuscles in theshoulder, waist,back, neck,upperextremities(arm), and lowerextremities (leg)due to strainfrom exercise ornormalhousehold workactivities.	Same
Comparison item		New device			Predicate device		Substantialequivalencedetermination
		R-C1TENS andEMS Stimulator	R-E1 EMSStimulator	R-T1 TENSStimulator	MT9001	LT3060
Prescription or OTC		OTC	OTC	OTC	OTC	OTC	Same
FDA product code		NUH, NGX	NGX	NUH	NUH, NGX	NUH	Same
Basic technological characteristics
Power source		Battery powered, d.c. 6.0V, 4 X AAA batteries			Battery powered, d.c.9.0V, one 6F22 battery		Different but does notadversely impactsafety andeffectiveness ofsubject device
User interface		By LCD display			By LCD display	By LCD display	Same
Output channel		Two channels			Two channels		Same
Number of output models		TENS and EMS	EMS	TENS	TENS andEMS	TENS	Same
Number of treatment programs		For TENS: 18For EMS: 15	15	18	For TENS: 4;For EMS: 3	?	N/A
Number ofoutput channels	SynchronousorAlternating?		Alternating		Alternating		Same
Number of output channels		2			2		Same
Method of channel isolation		By electrical circuit and software			By electrical circuit andsoftware		Same
Constant Current or ConstantVoltage?		Constant current			Constant current		Same
	New device			Predicate device		Substantialequivalencedetermination
Comparison item	R-C1TENS andEMS Stimulator	R-E1 EMSStimulator	R-T1 TENSStimulator	MT9001	LT3060
Constant Current or ConstantVoltage?	Constant current			Constant current		Same
Waveform	Biphasic square			Biphasic square		Same
Software/Firmware/Microprocessor Control?	Yes			Yes		Same
Automatic overload trip?	Yes			Yes		Same
Automatic Over Current Trip?	Yes			Yes		Same
Automatic No Load Trip?	Yes			Yes		Same
Automatic shut off?	Yes			Yes		Same
Patient Override Control?	Yes			Yes		Same
Indicationfunction	On/off status?	Yes		Yes		Same
	Low battery?	Yes		Yes		Same
	Voltage/ currentlevel?	Yes		Yes		Same
Time range (min)	Nonadjustable 28, 30 and 32 minutes			1-60 minutes		Different butdoes notadversely impactsafety andeffectiveness ofsubject device
Comparison item	New device			Predicate device		Substantialequivalencedetermination
	R-C1TENS and EMSStimulator	R-E1 EMSStimulator	R-T1 TENSStimulator	MT9001	LT3060
PatientLeakageCurrent	- Normalcondition (uA)11.4 uA	11.4 uA	11.4 uA	0.61uA
	- Single faultcondition (uA)9.6uA	9.6uA	9.6uA		0.68uA
	Average DC current throughelectrodes when device is on butno pulses are being applied (uA)	TENS: N/AEMS: 0No output nopulse applied	TENS: 0EMS: N/ANo output nopulse applied	TENS: 0EMS: 0No output no pulseapplied		Same
	Housing materials construction	Plastic (ABS) enclosure		Plastic (ABS) enclosure		Same
	Treatment area	Any area(Except thosetreatment areawhich beendescribed in theuser manual cannot use )	Shoulder, waist,back, neck,upperextremities(arm), Lowerextremities(leg);	For TENS mode:shoulder, waist, back,neck, upperextremities(arm), Lowerextremities (leg);For EMS: Any area(Except those treatmentarea which beendescribed in the usermanual can not use )		Same

	TENS: 0EMS: 0No output no pulseapplied
	Comparison item	New device			Predicate device		Substantialequivalencedetermination
		R-C1TENS and EMSStimulator	R-E1 EMSStimulator	R-T1 TENSStimulator	MT9001	LT3060
	List of applied part material(s)	Electrode - silica gel			Electrode - silica gel		Same
	Compliance with 21 CFR 898 ?	Yes			Yes		Same
Classification	Type of protectionagainst electric shock	Internally powered equipment			Internally poweredequipment		Same
	Degree of protectionagainst electric shock	Type BF applied part			Type BF applied part		Same
	Device Class	Class II			Class II		Same
CompliancewithVoluntaryStandards?	Mechanical Safety	Compliant with requirements of IEC 60601-1, IEC 60601-2-10 safety standards					Same
	Electrical Safety	Compliant with requirements of IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2 safetystandards					Same
	Energy delivered	The delivered energy is limited according to requirements of collateral IEC 60601-2-10safety standards					Same
	Other	Compliant with requirements of IEC 60601-11 safety standard					Same
	Applied part	Electrode pad			Electrode pad		Same
	Weight (lbs., oz.)	0.243			0.28		Slightly differentbut does notimpact safetyandeffectiveness ofsubject device
Comparison item	New device			Predicate device		Substantialequivalencedetermination
	R-C1TENS andEMS Stimulator	R-E1 EMSStimulator	R-T1 TENSStimulator	MT9001	LT3060
Dimensions(in.) [W × H × D]For unit	4.82x2.78x1.08			4.5x2.55x0.9		Slightly different butdoes not impactsafety andeffectiveness ofsubject device
Operating temperature andhumidity	5°C~~40°C; 15%RH~~93%RH;			Unknowable		Slightly different butdoes not impactsafety andeffectiveness ofsubject device
Storage temperature andhumidity	-10°C~~55°C; 10%RH~~90%RH;			Unknowable
Output Specifications
Waveform	TENS mode	Biphasic	N/A	Biphasic	Biphasic		Same
	EMS mode	Biphasic	Biphasic	N/A	Biphasic		Same
Shape	TENS mode	Square	N/A	Square	Square		Same
	EMS mode	Square	Square	N/A	Square		Same
Maximumoutputvoltage(Vpp)	@500Ω	30	30	30	48	48	Different but doesnot adversely
	@2KΩ	108	108	108	100	114	not adversely
	@10KΩ	108	108	108	105	115	impact safety andeffectiveness ofsubject device
Max OutputCurrent (mA)	@500Ω	60	60	60	96		Different but does
	@2KΩ	54	54	54	50	57	not adversely
	@10KΩ	10.8	10.8	10.8	10.5	11.5	impact safety andeffectiveness ofsubject device
Comparison item	New device			Predicate device		Substantial equivalence determination
	R-C1TENS andEMS Stimulator	R-E1 EMSStimulator	R-T1 TENSStimulator	MT9001	LT3060
Pulse Width Range(uS)	100-380uS	200-380uS	100-330uS	50-300uS	50-300uS	Different but does notadversely impact safetyand effectiveness ofsubject device
Frequency (Hz)	1-125Hz	1-110Hz	2-125Hz	1-150Hz	1-150Hz	Different but does notadversely impact safetyand effectiveness ofsubject device
Formulti-programwaveformsonly	Symmetricalphases?	Yes	Yes	Yes	Yes	Same
	PhaseDuration	100-380uS	200-380uS	100-330uS	50-300uS	50-300uS
Net Charge per pulse cycle(uC, 500Ω)	0	0	0	0	0	Same
Maximum Phase Charge(uC, 500Ω)	22.8	22.8	19.8		0.0288
Maximum Current Density(mA/cm², 500Ω, r.m.s)	2.4	2.4	2.4		1.15	Different but does notadversely impact safetyand effectiveness ofsubject device
Max. average current (averageabsolute value, mA)	0.675	0.675	0.617		4.32	Different but does notadversely impact safetyand effectiveness ofsubject device
Maximum Power Density(W/cm², 500Ω, r.m.s)	0.23	0.072	0.23		0.373
Comparison item		New device			Predicate device		Substantialequivalencedetermination
Burst mode(i.e. pulsetrains)	Pulses per burst	25	N/A	25	7	N/A	Different but doesnot adverselyimpact safety andeffectiveness ofsubject device
	Bursts persecond (Hz)	2	N/A	2	0.5,0.7,1,2,3,4,5	N/A
	Burst duration	250ms	N/A	250ms	70ms	N/A
	Duty cycle	500ms	N/A	500ms	35ms/350ms	N/A
On time (s)		0.5-12	N/A	0.5-12	N/A	1-30	Similar and doesnot impact safetyand effectivenessof subject device
OFF time (s)		0.5-1	N/A	0.5-1	N/A	1-60	and effectivenessof subject device
Electrode area (cm²)		25	25	25	25	25	Same
		R-C1TENS andEMS Stimulator	R-E1 EMSStimulator	R-T1 TENSStimulator	MT9001	LT3060

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Image /page/15/Picture/0 description: The image is a logo for ROOVJOY. The text "ROOVJOY" is in white, bold, sans-serif font. The letters are evenly spaced and of uniform size. A red crescent shape is behind the "VJOY" portion of the text. The background is black.

Similarity and Difference

The RW series A Electrical stimulators (Model R-C1 TENS and EMS stimulator and model R-T1 TENS Stimulator) has been compared with "OTC electrical stimulator Models MT9001, LT3060". The subject device has and principle of operation, similar technological chat predicate device. Although there are several specifications that are different between two devices, the comparison analysis has been completed to demonstrate that the differences between the served by the adversely impact the safety and effectiveness of the subject device has undergone safety and performance tests, and the results complied with the test requests. Therefore, the difference between the predicate device did not raise any problem of substantial equivalence. The subject device is substantially equivalent to the predicate devices in safety and performance claims.

9. Conclusions

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After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that the RW series A Electrical stimulators (Model R-C1 TENS and EMS stimulator and model R-T1 TENS Stimulator) is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).