1. Relaxation of muscle spasm;
1. Increase of local blood flow circulation;
1. Prevention or retardation of disuse atrophy;
1. Muscle re-education;
1. Maintaining or increasing range of motion;
1. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
R-E1 EMS Stimulator
1. Relaxation of muscle spasm;
1. Increase of local blood flow circulation;
1. Prevention or retardation of disuse atrophy;
1. Muscle re-education;
1. Maintaining or increasing range of motion;
1. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
R-T1 TENS Stimulator
1. Symptomatic relief of chronic intractable pain;
1. Post traumatic pain;
1. Post surgical pain.

Device Description

The RW Series A Electrical Stimulator, which includes models R-C1, R-E1 and R-T1, are Transcutaneous Electrical Nerve Stimulator and muscle stimulator for pain relief and/or Electrical Muscle 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 stimulator is used with electrodes. For the electrodes are provided by the manufacturer Top-Rank Health Care Equipment Co. Ltd, cleared under K070612.

The three models of R-C1, R-E1 and R-T1 have the same appearance, structure, display, electrical principle and critical components, the main differences are software and color. The R-C1 have TENS mode (12 programs), EMS mode (9 programs). The R-E1 only have EMS mode (9 programs) and R-T1 only have TENS mode (12 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 the Shenzhen Roundwhale Technology Co., Ltd. R-C1 TENS and EMS Stimulator, R-E1 EMS Stimulator, and R-T1 TENS Stimulator. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a novel device or algorithm.

Therefore, much of the requested information regarding acceptance criteria and studies (especially for AI/ML performance) is not applicable or cannot be directly extracted from this type of regulatory submission. The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence."

However, I can extract information related to non-clinical testing and performance standards used to demonstrate safety and performance.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of device are primarily compliance with recognized consensus standards for safety and performance. The performance reported is that the device "meets the requirements of its pre-defined acceptance criteria and intended uses."

Item	Acceptance Criteria (Applicable Standard)	Reported Device Performance
Safety	IEC 60601-1:2005+A1:2012 (Medical electrical equipment – General requirements for basic safety and essential performance)	Conform
Electromagnetic Compatibility (EMC)	IEC 60601-1-2:2014 (Medical electrical equipment – Electromagnetic disturbances – Requirements and tests)	Conform
Home Healthcare Environment	IEC 60601-1-11:2015 (Medical electrical equipment – Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment)	Conform
Performance	IEC 60601-2-10:2012+A1:2016 (Medical electrical equipment – Particular requirements for the basic safety and essential performance of nerve and muscle stimulators)	Conform
Software	IEC 62304:2006 (Medical device software – Software life cycle processes)	Conform
Usability	IEC 62366-1:2015 (Medical devices – Application of usability engineering to medical devices)	Conform
Risk Management	ISO 14971:2007 (Medical devices – Application of risk management to medical devices)	Conform
Shelf life	N/A (Internal company specification)	Meets requirements
Software Validation	N/A (Internal company specification)	Meets requirements
Electrical Safety (Patient Leakage Current)	IEC 60601-1 requirements (e.g., limits for normal and single fault conditions)	Normal condition: 11.4 uA; Single fault condition: 9.6 uA (Meets requirements)
Average DC current through electrodes	IEC 60601-2-10 requirements (0 when no pulses applied)	0 (for TENS and EMS modes, when no pulses applied)
Electrode Pads Biocompatibility	ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process)	Compliance claimed

Study Proving Acceptance Criteria

The study performed was a series of non-clinical safety and performance tests conducted on the subject device (RW series A Electrical stimulator: R-C1, R-E1 and R-T1). The document states: "All the test results demonstrate RW series A Electrical stimulator (R-C1, R-E1 and R-T1) meets the requirements of its pre-defined acceptance criteria and intended uses, and is substantially equivalent to the predicate devices."

The specific types of non-clinical tests mentioned are:

Shelf life
Software validation
Electromagnetic compatibility and electrical safety (verified against IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10)
Function test
Usability (verified against IEC 62366-1)
Risk management (verified against ISO 14971)

2. Sample Size for Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated, however, for non-clinical engineering and performance testing as described, it typically involves a small number of devices (e.g., 3-5 units) undergoing specific tests to demonstrate compliance with standards. It does not refer to a "test set" in the context of clinical trials or AI/ML validation data.
Data Provenance: The tests were performed on the devices manufactured by Shenzhen Roundwhale Technology Co., Ltd. The document refers to "non-clinical laboratory studies and safety testing data." This implies the data was generated internally as part of the device development and validation process, likely in China where the manufacturer is based. It is retrospective in the sense that these tests were performed on the final device design to support regulatory submission.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not applicable. This submission relates to a physical medical device (electrical stimulator) which demonstrates safety and performance through engineering tests against recognized standards, not through clinical data where expert-established ground truth would be required.
Qualifications of Experts: Not applicable.

4. Adjudication Method for Test Set

Adjudication Method: Not applicable. This is not a clinical study involving ambiguity or subjective assessments. Compliance with engineering standards is typically determined by objective measurements and pass/fail criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. This is not an AI/ML device or an imaging device for which an MRMC study would be relevant. The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence."
Effect Size of Human Readers with/without AI: Not applicable.

6. Standalone (Algorithm Only) Performance Study

Standalone Study: No. This is a hardware medical device; it does not involve a standalone algorithm for diagnostic or prognostic purposes.

7. Type of Ground Truth Used

Type of Ground Truth: The "ground truth" here is compliance with established international and FDA-recognized consensus standards (e.g., IEC 60601 series, ISO 14971, IEC 62304, IEC 62366-1) and internal design specifications for the device's electrical characteristics and functionality. These standards define the acceptable range of performance and safety parameters.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device does not use an AI/ML model that requires a training set.

9. How Ground Truth for Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable.

Summary

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September 7, 2018

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

Re: K181688

Trade/Device Name: R-C1 TENS and EMS Stimulator: R-E1 EMS Stimulator: R-T1 TENS Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZJ Dated: June 6, 2018 Received: June 26, 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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) K181688

Device Name

R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator

Indications for Use (Describe)

R-C1 TENS and EMS Stimulator

For TENS mode:

1. Symptomatic relief of chronic intractable pain;
1. Post traumatic pain;
1. Post surgical pain;

For EMS mode:

1. Relaxation of muscle spasm;
1. Increase of local blood flow circulation;
1. Prevention or retardation of disuse atrophy;
1. Muscle re-education;
1. Maintaining or increasing range of motion;
1. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
R-E1 EMS Stimulator
1. Relaxation of muscle spasm;
1. Increase of local blood flow circulation;
1. Prevention or retardation of disuse atrophy;
1. Muscle re-education;
1. Maintaining or increasing range of motion;
1. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
R-T1 TENS Stimulator
1. Symptomatic relief of chronic intractable pain;
1. Post traumatic pain;
1. Post surgical pain.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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-FDAP-8 Date: Aug. 24, 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: _ K181688

Information of Submitter and Correspondent 1.

Submitter's information:

Company Name:	Shenzhen Roundwhale Technology Co., Ltd
Street Address:	No. 615, Building C of Sanlian Industrial Zone, Shiyan, BaoanDistrict
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, For pain reliefper 21 CFR § 882.5890
Device Class:	Class II
Product Code:	IPF, GZJ

b) Trade Name: R-E1, EMS Stimulator Common Name: Powered Muscle Stimulator Classification Name: Stimulator, Muscle, Powered, for muscle conditioning per 21 CFR § 890.5850; Device Class: Class II IPF Product Code:

c) Trade Name:	R-T1, TENS Stimulator
Common Name:	TENS or TENS Device
Classification Name:	Transcutaneous Electrical Nerve Stimulator for Pain ReliefStimulator, Nerve, Transcutaneous, For pain reliefper 21 CFR § 882.5890
Device Class:	Class II
Product Code:	GZJ

3. Identification of Predicate Device(s)

Manufacturer	Famidoc Technology Co., Ltd
Legally Marketed Device	FDES101(ED401), FDES102(ED402),FDES103(ED403)
510 (K) Number	K113010

4. Description of Device

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

The stimulator is used with electrodes. For the electrodes are provided by the manufacturer Top-Rank Health Care Equipment Co. Ltd, cleared under K070612.

5. Intended Use

R-C1, TENS and EMS Stimulator

For TENS mode:

Symptomatic relief of chronic intractable pain; 1.
1. Post traumatic pain;
1. Post surgical pain;

For EMS mode:

Relaxation of muscle spasm; 1.
1. Increase of local blood flow circulation;
1. Prevention or retardation of disuse atrophy;
1. Muscle re-education:
1. Maintaining or increasing range of motion;
1. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

R-E1, EMS Stimulator

Relaxation of muscle spasm; 1.
1. Increase of local blood flow circulation;
1. Prevention or retardation of disuse atrophy;
1. Muscle re-education;
1. Maintaining or increasing range of motion;

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1. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

R-T1, TENS Stimulator

1. Symptomatic relief of chronic intractable pain;
Post traumatic pain; 2.
1. Post surgical pain;
Discussion of Non-Clinical Tests Performed for Determination of 6. 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 stimulator (R-C1, R-E1 and R-T1).

Shelf life
Software validation
Electromagnetic compatibility and electrical safety
Function test

All the test results demonstrate RW series A Electrical stimulator (R-C1, R-E1 and R-T1) 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

The devices conform to applicable standards as follow table:

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

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Software	IEC 62304:2006	Yes	Conform
Usability	IEC 62366-1:2015	Yes	Conform
Risk management	ISO 14971:2007	Yes	Conform

8. Comparison for Predicate Device & Subject Device

The RW series A Electrical stimulator (R-C1, R-E1 and R-T1) submitted in this 510(k) file is substantially equivalent in intended use, design, technology/ principles of operation, materials and performance to the cleared Electrical stimulator models FDES101(ED401), FDES102(ED402) and FDES103(ED403) (K113010). 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-C1 TENS and EMSStimulator	R-E1EMS Stimulator	R-T1TENS Stimulator	FDES101(ED401) TENSand EMSStimulator	FDES102(ED402) TENSStimulator	FDES103(ED403) EMSStimulator
510K#	K181688			K113010			N/A
Manufacturer	Shenzhen Roundwhale Technology Co., Ltd.			Famidoc Technology Co., Ltd			N/A
Number of outputmodels	TENS and EMS	EMS	TENS	TENS andEMS	TENS	EMS	Same
Intended use	For TENS mode:1. Symptomatic relief of chronic intractable pain;2. Post traumatic pain;3. Post surgical pain;For EMS mode:1. Relaxation of muscle spasm;2. Increase of local blood flow circulation;3. Prevention or retardation of disuse atrophy;4. Muscle re-education;5. Maintaining or increasing range of motion;6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.			For TENS mode:1. Symptomatic relief of chronic intractable pain;2. Post traumatic pain;3. Post surgical pain;For EMS mode:1. Relaxation of muscle spasm;2. Increase of local blood flow circulation;3. Prevention or retardation of disuse atrophy;4. Muscle re-education;5. Maintaining or increasing range of motion;6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

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Comparison item			New device			Predicate device			Substantialequivalencedetermination
			R-C1 TENS andEMS Stimulator	R-E1EMSStimulator	R-T1TENSStimulator	FDES101(ED401) TENSand EMSStimulator	FDES102(ED402)TENSStimulator	FDES103(ED403) EMSStimulator
Prescription or OTC			Prescription	Prescription	Prescription	Prescription	Prescription	Prescription	Same
FDA product code			IPF, GZJ	IPF	GZJ	IPF, GZJ	GZJ	IPF	Same
Basic technological characteristics
Power source			Battery powered, d.c. 6.0V, 4 X AAA batteries			Battery powered, d.c. 6.0V, 4 X AAA batteries			Same
User interface				By LCD display			By LCD display		Same
Output channel			Two channels			Two channels			Same
Number of treatment programs			For TENS: 12For EMS: 9	9	12	For TENS: 15;For EMS: 15	15	15	N/A
Number ofoutput channels	Synchronous orAlternating?		Alternating			Synchronous an Alternating			Same
Number of output channels				2		2			Same
Method of channel isolation				By electrical circuit and software		By electrical circuit and software			Same
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
			New device			Predicate device			Substantialequivalencedetermination
Comparison item			R-C1 TENS andEMS Stimulator	R-E1EMSStimulator	R-T1TENSStimulator	FDES101(ED401) TENSand EMSStimulator	FDES102(ED402)TENSStimulator	FDES103(ED403)EMSStimulator
Patient Override Control?			No	No	No	No	No	No	Same
Indicationfunction	On/off status?		Yes	Yes	Yes	Yes	Yes	Yes	Same
	Low battery?		Yes	Yes	Yes	Yes	Yes	Yes	Same
Voltage/ currentlevel?			Yes	Yes	Yes	Yes	Yes	Yes	Same
Time range (min)			Nonadjustable 28, 30 and 32 minutes			0-60 minutes			Different butdoes notadverselyimpact safetyandeffectiveness ofsubject deviceSE, meet therequirements ofIEC 60601-1
PatientLeakageCurrent	- Normal condition (uA)		11.4 uA	11.4 uA	11.4 uA	3.0uA			SE, meet therequirements ofIEC 60601-1
	- Single faultcondition (uA)		9.6uA	9.6uA	9.6uA		5.8uA
Average DC current throughelectrodes when device is on butno pulses are being applied (uA)			TENS: 0EMS: 0No output nopulse applied	EMS: 0No output nopulse applied	TENS: 0Nooutputno pulseapplied	TENS: 0EMS: N/ANo outputno pulseapplied	TENS: 0No outputno pulseapplied	EMS: 0No outputno pulseapplied	Same
Comparison item			New device			Predicate device			Substantialequivalencedetermination
			R-C1 TENS andEMS Stimulator	R-E1EMSStimulator	R-T1TENSStimulator	FDES101(ED401) TENSand EMSStimulator	FDES102(ED402)TENSStimulator	FDES103(ED403)EMSStimulator
Treatment area			Any area (Except those treatment area whichbeen described in the user manual can notuse), such as Hand, Arm, Chest, Waist,Buttock, Thigh, Calf, Back and low back etc.			Any area (Except those treatment areawhich been described in the usermanual can not use), such as Hand,Arm, Chest, Waist, Buttock, Thigh, Calf,Back and low back etc.			Same
List of applied part material(s)			Electrode – silica gel			Electrode – silica gel			Same
Compliance with 21 CFR 898?			Yes			Yes			Same
Electrode pads			Compliance with ISO 10993-1, provided byTop-Rank 50*50mm, Transparent silica gel			Compliance with ISO 10993-1, providedby Top-Rank 50*50mm, Transparentsilica gel			Same
Classification	Type of protectionagainst electricshock		Internally powered equipment			Internally powered equipment			Same
	Degree ofprotection againstelectric shock		Type BF applied part			Type BF applied part			Same
	Device Class		Class II			Class II			Same
Compliance withVoluntaryStandards?	Mechanical Safety		Compliant with requirements of IEC 60601-1, IEC 60601-2-10 safety standards			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			Compliant with requirements of IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2 safetystandards			Same
Comparison Item		New device			Predicate device			Substantial equivalence determination
		R-C1 TENS and EMS Stimulator	R-E1 EMS Stimulator	R-T1 TENS Stimulator	FDES101 (ED401) TENS and EMS Stimulator	FDES102 (ED402) TENS Stimulator	FDES103 (ED403) EMS Stimulator
Compliance with Voluntary Standards?	Energy delivered	The delivered energy is limited according to requirements of collateral IEC 60601-2-10 safety 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		0.35			Slightly different but does not impact safety and effectiveness of subject device
Dimensions(in.) [W × H × D]For unit			4.82x2.78x1.08		5.1x2.99x1.38			Slightly different but does not impact safety and effectiveness of subject device
Operating temperature and humidity			5°C~~40°C; 15%RH~~93%RH;		5°C~~40°C; 30%RH~~75%RH;
Storage temperature and humidity			-10°C~~55°C; 10%RH~~90%RH;		-10°C~~50°C; 10%RH~~90%RH;
Comparison item			New device			Predicate device			Substantialequivalencedetermination
			R-C1 TENSand EMSStimulator	R-E1EMSStimulator	R-T1TENSStimulator	FDES101(ED401) TENSand EMSStimulator	FDES102(ED402) TENSStimulator	FDES103(ED403) EMSStimulator
Output Specifications
Waveform	TENS mode	Biphasic	N/A	Biphasic	Biphasic	Biphasic	N/A	Same
	EMS mode	Biphasic	Biphasic	N/A	Biphasic	N/A	Biphasic	Same
Shape	TENS mode	Square	N/A	Square	Square	Square	N/A	Same
	EMS mode	Square	Square	N/A	Square	N/A	Square	Same
	@500Ω	30	30	30	30	30	30	Same
Maximumoutputvoltage(Vpp)	@2KΩ	108	108	108	90	90	90	Different butdoes notadverselyimpact safetyandeffectivenessof subjectdevice
	@10KΩ	108	108	108	96	96	96
	@500Ω	60	60	60	60	60	60	Same
Max OutputCurrent (mA)	@2KΩ	54	54	54	45	45	45	Different butdoes notadverselyimpact safetyandeffectivenessof subjectdevice
	@10KΩ	10.8	10.8	10.8	9.6	9.6	9.6
	Pulse Width Range(uS)		100-380uS	200-380uS	100-330uS	50-300us	50-300us	50-300us	adverselyimpact safetyandeffectivenessof subjectdevice
Frequency (Hz)		1-125Hz	1-110Hz	2-125Hz	0.5-150Hz	0.5-150Hz	1-150Hz
Comparison item	New device			Predicate device			Substantialequivalencedetermination
	R-C1 TENS andEMS Stimulator	R-E1EMSStimulator	R-T1TENSStimulator	FDES101(ED401) TENSand EMSStimulator	FDES102(ED402)TENSStimulator	FDES103(ED403)EMSStimulator
Formulti-programwaveformsonly	Symmetricalphases?	Yes	Yes	Yes	Yes	Yes	Yes	Same
	PhaseDuration	100-380uS	200-380uS	100-330uS	50-300uS	50-300uS	50-300uS	Different butdoes notadverselyimpact safetyandeffectiveness ofsubject device
Net Charge per pulse cycle(uC, 500Ω)		0	0	0	0	0	0	Same
Maximum Current Density(mA/cm², 500Ω, r.m.s)		2.4	2.4	2.4	2.4	2.4	2.4	Same
Maximum Phase Charge(uC, 500Ω)		22.8	22.8	19.8	18	18	18	Different butdoes notadverselyimpact safetyandeffectiveness ofsubject device
Max. average current (averageabsolute value, mA)		16.8	16.8	15.4	10.4	10.4	10.4	Different butdoes notadverselyimpact safetyandeffectiveness ofsubject device
Maximum Power Density(W/cm², 500Ω, r.m.s)		0.072	0.072	0.072	0.072	0.072	0.07009	Different butdoes notadverselyimpact safetyandeffectiveness ofsubject device
Comparison item		New device			Predicate device			Substantialequivalencedetermination
		R-C1 TENS andEMS Stimulator	R-E1EMSStimulator	R-T1TENSStimulator	FDES101(ED401) TENSand EMSStimulator	FDES102(ED402)TENSStimulator	FDES103(ED403) EMSStimulator
Burst mode (i.e.pulse trains)	Pulses perburst	25	N/A	25	10	10	N/A	Different butdoes notadverselyimpact safetyandeffectiveness ofsubject device
	Bursts persecond (Hz)	2	N/A	2	0.5,1,2,3,4,5	0.5,1,2,3,4,5	N/A
	Burstduration	250ms	N/A	250ms	10ms	10ms	N/A
	Duty cycle	500ms	N/A	500ms	10ms/100ms	10ms/100ms	N/A
On time (s)		0.5-12	N/A	0.5-12	0-30	N/A	0-30	Similar anddoes not impactsafety andeffectiveness ofsubject device
OFF time (s)		0.5-1	N/A	0.5-1	0-30	N/A	0-30	safety andeffectiveness ofsubject device
Electrode area (cm2)		25	25	25	25	25	25	Same

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Similarity and Difference

The RW series A Electrical stimulators (R-C1, R-E1 and R-T1) has been compared with "Electrical stimulator Models FDES101(ED401), FDES102(ED402) and FDES103(ED403)". The subject device has same intended use and principle of operation, similar technological characteristics as that predicate device. Although that are different between two devices, the comparison analysis has been completed to demonstrate that the differences between these parameters would not adversely impact the safety and effectiveness of the subject device has undergone safety and performance tests, and the results complied with the test

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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.

7. Conclusions

After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that the RW series I stimulators (R-C1, R-E1 and R-T1) is substantially equivalent to the 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).