Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard electrical stimulator with pre-set programs and adjustable intensity controlled by buttons. There is no mention of AI, ML, or any adaptive or learning capabilities.

Therapeutic

Yes

The device's intended uses clearly describe the symptomatic relief of pain, relaxation of muscle spasms, increase of local blood flow, and prevention of disuse atrophy, which are all therapeutic purposes.

Diagnostic

No

The device is an electrical stimulator (TENS and EMS) used for pain relief and muscle stimulation, not for diagnosing conditions. Its intended uses include symptomatic relief of pain, muscle relaxation, increasing blood flow, and muscle re-education, all of which are therapeutic rather than diagnostic.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "portable device, battery powered" and "sends gentle electrical current... via electrodes applied on the skin," indicating it is a physical hardware device that delivers electrical stimulation. While software controls the parameters, it is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
Device Function: The R-C1 TENS and EMS Stimulator, and its variations, are external electrical stimulators that apply current to the skin to affect nerves and muscles. They do not analyze biological samples.
Intended Use: The intended uses listed are for pain relief, muscle stimulation, and related physical therapy applications. These are not diagnostic purposes based on analyzing biological samples.
Device Description: The description clearly states it sends electrical current via electrodes applied to the skin. There is no mention of collecting or analyzing biological specimens.

Therefore, the R-C1 TENS and EMS Stimulator falls under the category of a therapeutic or physical medicine device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

R-C1 TENS and EMS Stimulator:
For TENS mode:

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

For EMS mode:

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

R-E1 EMS Stimulator:

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

R-T1 TENS Stimulator:

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

Product codes (comma separated list FDA assigned to the subject device)

IPF, GZJ

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Any area (Except those treatment area which been described in the user manual can not use), such as Hand, Arm, Chest, Waist, Buttock, Thigh, Calf, Back and low back etc.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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

Performance Summary: The devices conform to applicable standards as follow table:

Safety: IEC 60601-1:2005+A1:2012 (Conform)
EMC: IEC 60601-1-2:2014 (Conform)
Home healthcare environment: IEC 60601-1-11:2015 (Conform)
Performance: IEC 60601-2-10:2012+A1:2016 (Conform)
Software: IEC 62304:2006 (Conform)
Usability: IEC 62366-1:2015 (Conform)
Risk management: ISO 14971:2007 (Conform)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K113010

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

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.

1

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

2

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.

3

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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, 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 conditioning
per 21 CFR § 890.5850;
Transcutaneous Electrical Nerve Stimulator for Pain Relief;
Stimulator, Nerve, Transcutaneous, For pain relief
per 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 Relief
Stimulator, Nerve, Transcutaneous, For pain relief
per 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

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

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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.

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 recognized
consensus
standards | Justification |
|--------------------------------|---------------------------------|------------------------------------------|---------------|
| 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 |

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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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| 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 | |
| 510K# | K181688 | | | K113010 | | | N/A |
| Manufacturer | Shenzhen Roundwhale Technology Co., Ltd. | | | Famidoc Technology Co., Ltd | | | N/A |
| Number of output
models | TENS and EMS | EMS | TENS | TENS and
EMS | TENS | EMS | Same |
| Intended use | For TENS mode:

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

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| 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 | |
| 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: 12
For EMS: 9 | 9 | 12 | For TENS: 15;
For EMS: 15 | 15 | 15 | N/A |
| Number of
output channels | Synchronou
s or
Alternating? | | 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 Constant
Voltage? | | | 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 | | | Substantial
equivalence
determination |
| Comparison item | | | 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 | |
| Patient Override Control? | | | No | No | No | No | No | No | Same |
| Indication
function | On/off status? | | Yes | Yes | Yes | Yes | Yes | Yes | Same |
| | Low battery? | | Yes | Yes | Yes | Yes | Yes | Yes | Same |
| Voltage/ current
level? | | | Yes | Yes | Yes | Yes | Yes | Yes | Same |
| Time range (min) | | | Nonadjustable 28, 30 and 32 minutes | | | 0-60 minutes | | | Different but
does not
adversely
impact safety
and
effectiveness of
subject device
SE, meet the
requirements of
IEC 60601-1 |
| Patient
Leakage
Current | - Normal condition (uA) | | 11.4 uA | 11.4 uA | 11.4 uA | 3.0uA | | | SE, meet the
requirements of
IEC 60601-1 |
| | - Single fault
condition (uA) | | 9.6uA | 9.6uA | 9.6uA | | 5.8uA | | |
| Average DC current through
electrodes when device is on but
no pulses are being applied (uA) | | | TENS: 0
EMS: 0
No output no
pulse applied | EMS: 0
No output no
pulse applied | TENS: 0
No
output
no pulse
applied | TENS: 0
EMS: N/A
No output
no pulse
applied | TENS: 0
No output
no pulse
applied | EMS: 0
No output
no pulse
applied | 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 | |
| Treatment area | | | Any area (Except those treatment area which
been described in the user manual can not
use), such as Hand, Arm, Chest, Waist,
Buttock, Thigh, Calf, Back and low back etc. | | | Any area (Except those treatment area
which been described in the user
manual 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 by
Top-Rank 5050mm, Transparent silica gel | | | Compliance with ISO 10993-1, provided
by Top-Rank 5050mm, Transparent
silica gel | | | Same |
| Classificat
ion | Type of protection
against electric
shock | | Internally powered equipment | | | Internally powered equipment | | | Same |
| | Degree of
protection against
electric shock | | Type BF applied part | | | Type BF applied part | | | Same |
| | Device Class | | Class II | | | Class II | | | Same |
| Complian
ce with
Voluntary
Standards
? | 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 safety
standards | | | Compliant with requirements of IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2 safety
standards | | | 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 | | | 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 | |
| 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 | |
| Maximum
output
voltage
(Vpp) | @2KΩ | 108 | 108 | 108 | 90 | 90 | 90 | Different but
does not
adversely
impact safety
and
effectiveness
of subject
device | |
| | @10KΩ | 108 | 108 | 108 | 96 | 96 | 96 | | |
| | @500Ω | 60 | 60 | 60 | 60 | 60 | 60 | Same | |
| Max Output
Current (mA) | @2KΩ | 54 | 54 | 54 | 45 | 45 | 45 | Different but
does not
adversely
impact safety
and
effectiveness
of subject
device | |
| | @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 | adversely
impact safety
and
effectiveness
of subject
device |
| Frequency (Hz) | | 1-125Hz | 1-110Hz | 2-125Hz | 0.5-150Hz | 0.5-150Hz | 1-150Hz | | |
| 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 | | | |
| For
multi-program
waveforms
only | Symmetrical
phases? | Yes | Yes | Yes | Yes | Yes | Yes | Same | |
| | Phase
Duration | 100-380uS | 200-380uS | 100-330uS | 50-300uS | 50-300uS | 50-300uS | Different but
does not
adversely
impact safety
and
effectiveness of
subject 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 but
does not
adversely
impact safety
and
effectiveness of
subject device | |
| Max. average current (average
absolute value, mA) | | 16.8 | 16.8 | 15.4 | 10.4 | 10.4 | 10.4 | Different but
does not
adversely
impact safety
and
effectiveness of
subject device | |
| Maximum Power Density
(W/cm², 500Ω, r.m.s) | | 0.072 | 0.072 | 0.072 | 0.072 | 0.072 | 0.07009 | Different but
does not
adversely
impact safety
and
effectiveness of
subject device | |
| 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 | | |
| Burst mode (i.e.
pulse trains) | Pulses per
burst | 25 | N/A | 25 | 10 | 10 | N/A | Different but
does not
adversely
impact safety
and
effectiveness of
subject device | |
| | Bursts per
second (Hz) | 2 | N/A | 2 | 0.5,1,2,3,4,5 | 0.5,1,2,3,4,5 | N/A | | |
| | Burst
duration | 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 and
does not impact
safety and
effectiveness of
subject device | |
| OFF time (s) | | 0.5-1 | N/A | 0.5-1 | 0-30 | N/A | 0-30 | safety and
effectiveness of
subject device | |
| Electrode area (cm2) | | 25 | 25 | 25 | 25 | 25 | 25 | Same | |

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Image /page/11/Picture/0 description: The image shows the word "ROOVJOY" in white font on a black background. A red crescent shape is behind the "VJOY" portion of the word. The font is bold and sans-serif. The logo is simple and modern.

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Image /page/12/Picture/0 description: The image shows the word "ROOVJOY" in white letters on a black background. The letters are in a bold, sans-serif font. To the right of the word "ROOVJOY" is a red crescent shape. The crescent shape is open on the left side and curves around the letters "JOY".

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Image /page/13/Picture/0 description: The image shows the word "ROOVJOY" in white letters on a black background. To the right of the word is a red crescent shape. The font is sans-serif and the letters are all capitalized.

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Image /page/14/Picture/0 description: The image shows the word "ROOVJOY" in white letters on a black background. There is a red crescent shape that curves around the right side of the word. The font is sans-serif and appears to be bolded. The logo is simple and modern.

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Image /page/15/Picture/0 description: The image shows the word "ROOVJOY" in white font on a black background. A red crescent shape is behind the "VJOY" portion of the word. The font is bold and sans-serif. The logo is simple and modern.

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Image /page/16/Picture/0 description: The image shows the word "ROOVJOY" in white letters on a black background. A red crescent shape is behind the letters "OY" of the word. The font is sans-serif and the letters are bold.

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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Image /page/17/Picture/0 description: The image is a logo for ROOVJOY. The text "ROOVJOY" is in white, bold, sans-serif font. To the right of the text is a red crescent shape that partially encircles the "J" and "O" in "ROOVJOY". The background is black.

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.