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

K180956 · Shenzhen Roundwhale Technology Co. , Ltd. · NUH · Jun 7, 2018 · Neurology

Device Facts

• Record ID: K180956
• Device Name: Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator
• Applicant: Shenzhen Roundwhale Technology Co. , Ltd.
• Product Code: NUH · Neurology
• Decision Date: Jun 7, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

R-C1 TENS and EMS Stimulator 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 Story

RW Series A Electrical Stimulators (R-C1, R-E1, R-T1) are portable, battery-powered (6.0V DC) devices for TENS and/or EMS. Devices deliver gentle electrical current to nerves and muscles via skin-applied silica gel electrodes. User controls intensity via press buttons; LCD displays status. R-C1 combines TENS (18 programs) and EMS (15 programs); R-E1 provides EMS (15 programs); R-T1 provides TENS (18 programs). Used in home healthcare environment by patients for pain relief or muscle conditioning. Output is constant current, biphasic square waveform. Safety features include automatic overload, over-current, no-load trips, and automatic shut-off. Healthcare providers or patients use device to manage muscle pain or facilitate muscle performance, potentially reducing pain and improving muscle function.

Clinical Evidence

No clinical test data was used to support the decision of substantial equivalence. Evidence consists of bench testing, including shelf life, software validation, electromagnetic compatibility, electrical safety, and functional performance testing.

Technological Characteristics

Portable, battery-powered (4xAAA) stimulators. ABS plastic enclosure. Silica gel electrodes (50x50mm). Constant current, biphasic square waveform output. Two channels. Microprocessor-controlled. Compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, and ISO 14971. Type BF applied part.

Indications for Use

Indicated for temporary relief of pain associated with sore/aching muscles in shoulder, waist, back, neck, upper/lower extremities due to strain from exercise or household work (TENS mode); indicated for stimulation of healthy muscles to improve/facilitate muscle performance (EMS mode).

Regulatory Classification

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.

Predicate Devices

• MT9001 (K130802)
• LT3060 (K130802)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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

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.

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

| <input type="checkbox"/> <span>Research Use Only (Part 301 CFR 301.3: Select One)</span> | <input checked="checked" type="checkbox"/> <span>For In-Vitro Use Only (Part 301 CFR 301.3: Select One)</span> |
|------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
|------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|

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

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

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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: | [phone] |
| Fax: | [phone] |
| Contact Person: | Kevin Zhang |
| Contact Title: | General Manager |
| Contact Email: | [e-mail] |

#### 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: [e-mail]

#### 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<br>per 21 CFR § 890.5850;<br>Transcutaneous Electrical Nerve Stimulator for Pain Relief;<br>Stimulator, Nerve, Transcutaneous, Over-the-Counter<br>per 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 conditioning<br>per 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;<br>Stimulator, Nerve, Transcutaneous, Over-the-Counter<br>per 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

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

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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.

## 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

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.

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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 recognized<br>consensus<br>standards | Justification |
|--------------------------------|---------------------------------|------------------------------------------|---------------|
| Safety | IEC 60601-1:2005+<br>A1:2012 | Yes | Conform |
| EMC | IEC 60601-1-2:2014 | Yes | Conform |
| Home healthcare<br>environment | IEC 60601-1-11:2015 | Yes | Conform |
| Performance | IEC 60601-2-10:2012<br>+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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| Comparison<br>item | New device | | | Predicate device | | Substantial<br>equivalence<br>determination | |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| | R-C1TENS and EMS<br>Stimulator | R-E1 EMS<br>Stimulator | R-T1 TENS<br>Stimulator | 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 is<br>designed to be used for<br>temporary relief of pain<br>associated with sore and<br>aching muscles in the<br>shoulder, waist, back,<br>neck, upper extremities<br>(arm), and lower<br>extremities (leg) due to<br>strain from exercise or<br>normal household work<br>activities.<br>For EMS: This mode is<br>designed to be used for<br>stimulate healthy<br>muscles in order to<br>improve and facilitate<br>muscle performance. | This device is<br>designed to be<br>used for<br>stimulate<br>healthy muscles<br>in order to<br>improve and<br>facilitate muscle<br>performance. | This device is<br>designed to be<br>used for<br>temporary relief<br>of pain<br>associated with<br>sore and<br>aching muscles<br>in the shoulder,<br>waist, back,<br>neck, upper<br>extremities<br>(arm), and lower<br>extremities (leg)<br>due to strain<br>from exercise or<br>normal<br>household work<br>activities. | For TENS: This mode is<br>designed to be used for<br>temporary relief of pain<br>associated with sore and<br>aching muscles in the<br>shoulder, waist, back,<br>neck, upper extremities<br>(arm), and lower<br>extremities (leg) due to<br>strain from exercise or<br>normal household work<br>activities.<br>For EMS: This mode is<br>designed to be used for<br>stimulate healthy muscles<br>in order to improve and<br>facilitate muscle<br>performance. | The device is<br>designed to be<br>used for<br>temporary relief<br>of pain<br>associated with<br>sore and aching<br>muscles in the<br>shoulder, waist,<br>back, neck,<br>upper<br>extremities<br>(arm), and lower<br>extremities (leg)<br>due to strain<br>from exercise or<br>normal<br>household work<br>activities. | Same | |
| Comparison item | | New device | | | Predicate device | | Substantial<br>equivalence<br>determination |
| | | R-C1TENS and<br>EMS Stimulator | R-E1 EMS<br>Stimulator | R-T1 TENS<br>Stimulator | 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.<br>9.0V, one 6F22 battery | | Different but does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject 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 and<br>EMS | TENS | Same |
| Number of treatment programs | | For TENS: 18<br>For EMS: 15 | 15 | 18 | For TENS: 4;<br>For EMS: 3 | ? | N/A |
| Number of<br>output channels | Synchronous<br>or<br>Alternating? | | Alternating | | Alternating | | Same |
| Number of output channels | | 2 | | | 2 | | Same |
| Method of channel isolation | | By electrical circuit and software | | | By electrical circuit and<br>software | | Same |
| Constant Current or Constant<br>Voltage? | | Constant current | | | Constant current | | Same |
| | New device | | | Predicate device | | Substantial<br>equivalence<br>determination | |
| Comparison item | R-C1TENS and<br>EMS Stimulator | R-E1 EMS<br>Stimulator | R-T1 TENS<br>Stimulator | MT9001 | LT3060 | | |
| Constant Current or Constant<br>Voltage? | Constant current | | | Constant current | | Same | |
| Waveform | Biphasic square | | | Biphasic square | | Same | |
| Software/Firmware/<br>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 | |
| Indication<br>function | On/off status? | Yes | | Yes | | Same | |
| | Low battery? | Yes | | Yes…