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

K181688 · Shenzhen Roundwhale Technology Co. , Ltd. · IPF · Sep 7, 2018 · Physical Medicine

Device Facts

• Record ID: K181688
• Device Name: R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator
• Applicant: Shenzhen Roundwhale Technology Co. , Ltd.
• Product Code: IPF · Physical Medicine
• Decision Date: Sep 7, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

RW Series A Electrical Stimulators (R-C1, R-E1, R-T1) are portable, battery-powered (6.0V DC) devices delivering electrical currents to nerves and muscles via skin-applied electrodes. R-C1 combines TENS and EMS; R-E1 is EMS-only; R-T1 is TENS-only. Operation involves user-selected programs and intensity levels via press buttons. Devices use biphasic square waveforms in constant current mode. Used in clinical or home settings; operated by patients or clinicians. Output affects muscle contraction or nerve stimulation to manage pain or improve muscle function. Benefits include pain relief, muscle conditioning, and prevention of venous thrombosis.

Clinical Evidence

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

Technological Characteristics

Battery-powered (4xAAA, 6.0V DC); two-channel output; constant current; biphasic square waveform. Applied parts: silica gel electrodes (ISO 10993-1 compliant). Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-11 (home healthcare), IEC 60601-2-10 (performance), IEC 62304 (software), IEC 62366-1 (usability), ISO 14971 (risk management).

Indications for Use

Indicated for patients requiring symptomatic relief of chronic intractable, post-traumatic, or post-surgical pain (TENS mode) or muscle spasm relaxation, local blood flow circulation improvement, disuse atrophy prevention/retardation, muscle re-education, range of motion maintenance/increase, or post-surgical calf muscle stimulation to prevent venous thrombosis (EMS mode).

Regulatory Classification

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.

Predicate Devices

• Famidoc Technology Co., Ltd FDES101(ED401), FDES102(ED402), FDES103(ED403) (K113010)

Reference Devices

• Top-Rank Health Care Equipment Co. Ltd electrodes (K070612)

Submission Summary (Full Text)

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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 ([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) 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;
- 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.
- R-E1 EMS Stimulator
- 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.
- R-T1 TENS Stimulator
- 1. Symptomatic relief of chronic intractable pain;
- 2. Post traumatic pain;
- 3. 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, Baoan<br>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, For pain relief<br>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<br>Stimulator, Nerve, Transcutaneous, For pain relief<br>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),<br>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.
- 2. Post traumatic pain;
- 3. Post surgical pain;

#### For EMS mode:

- Relaxation of muscle spasm; 1.
- 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.

### R-E1, EMS Stimulator

- Relaxation of muscle spasm; 1.
- 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;

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- 6. 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.
- 3. 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<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 |

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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<br>item | New device | | | Predicate device | | | Substantial<br>equivalence<br>determination |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|--------------------------------------|---------------------------------------------|
| | R-C1 TENS and EMS<br>Stimulator | R-E1<br>EMS Stimulator | R-T1<br>TENS Stimulator | FDES101<br>(ED401) TENS<br>and EMS<br>Stimulator | FDES102<br>(ED402) TENS<br>Stimulator | FDES103<br>(ED403) EMS<br>Stimulator | |
| 510K# | K181688 | | | K113010 | | | N/A |
| Manufacturer | Shenzhen Roundwhale Technology Co., Ltd. | | | Famidoc Technology Co., Ltd | | | N/A |
| Number of output<br>models | TENS and EMS | EMS | TENS | TENS and<br>EMS | TENS | EMS | Same |
| Intended use | <b>For TENS mode:</b><br>1. Symptomatic relief of chronic intractable pain;<br>2. Post traumatic pain;<br>3. Post surgical pain;<br><b>For EMS mode:</b><br>1. Relaxation of muscle spasm;<br>2. Increase of local blood flow circulation;<br>3. Prevention or retardation of disuse atrophy;<br>4. Muscle re-education;<br>5. Maintaining or increasing range of motion;<br>6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. | | | <b>For TENS mode:</b><br>1. Symptomatic relief of chronic intractable pain;<br>2. Post traumatic pain;<br>3. Post surgical pain;<br><b>For EMS mode:</b><br>1. Relaxation of muscle spasm;<br>2. Increase of local blood flow circulation;<br>3. Prevention or retardation of disuse atrophy;<br>4. Muscle re-education;<br>5. Maintaining or increasing range of motion;<br>6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. | | | |

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| Comparison item | | | New device | | | Predicate device | | | Substantial<br>equivalence<br>determination |
|----------------------------------------------------------------------------------------------------|---------------------------------------------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|---------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | R-C1 TENS and<br>EMS Stimulator | R-E1<br>EMS<br>Stimulator | R-T1<br>TENS<br>Stimulator | FDES101<br>(ED401) TENS<br>and EMS<br>Stimulator | FDES102<br>(ED402)<br>TENS<br>Stimulator | FDES103<br>(ED403) EMS<br>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<br>For EMS: 9 | 9 | 12 | For TENS: 15;<br>For EMS: 15 | 15 | 15 | N/A |
| Number of<br>output channels | Synchronou<br>s or<br>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<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 |
| | | | New device | | | Predicate device | | | Substantial<br>equivalence<br>determination |
| Comparison item | | | R-C1 TENS and<br>EMS Stimulator | R-E1<br>EMS<br>Stimulator | R-T1<br>TENS<br>Stimulator | FDES101<br>(ED401) TENS<br>and EMS<br>Stimulator | FDES102<br>(ED402)<br>TENS<br>Stimulator | FDES103<br>(ED403)<br>EMS<br>Stimulator | |
| Patient Override Control? | | | No | No | No | No | No | No | Same |
| Indication<br>function | On/off status? | | Yes | Yes | Yes | Yes | Yes | Yes | Same |
| | Low battery? | | Yes | Yes | Yes | Yes | Yes | Yes | Same |
| Voltage/ current<br>level? | | | Yes | Yes | Yes | Yes | Yes | Yes | Same |
| Time range (min) | | | Nonadjustable 28, 30 and 32 minutes | | | 0-60 minutes | | | Different but<br>does not<br>adversely<br>impact safety<br>and<br>effectiveness of<br>subject device<br>SE, meet the<br>requirements of<br>IEC 60601-1 |
| Patient<br>Leakage<br>Current | - Normal condition (uA) | | 11.4 uA | 11.4 uA | 11.4 uA | 3.0uA | | | SE, meet the<br>requirements of<br>IEC 60601-1 |
| | - Single fault<br>condition (uA) | | 9.6uA | 9.6uA | 9.6uA | | 5.8uA | | |
| Average DC current through<br>electrodes when device is on but<br>no pulses are being applied (uA) | | | TENS: 0<br>EMS: 0<br>No output no<br>pulse applied | EMS: 0<br>No output no<br>pulse applied | TENS: 0<br>No<br>output<br>no pulse<br>applied | TENS: 0<br>EMS: N/A<br>No output<br>no pulse<br>applied | TENS: 0<br>No output<br>no pulse<br>applied | EMS: 0<br>No output<br>no pulse<br>applied | Same |
| Comparison item | | | New device | | | Predicate device | | | Substantial<br>equivalence<br>determination |
| | | | R-C1 TENS and<br>EMS Stimulator | R-E1<br>EMS<br>Stimulator | R-T1<br>TENS<br>Stimulator | FDES101<br>(ED401) TENS<br>and EMS<br>Stimulator | FDES102<br>(ED402)<br>TENS<br>Stimulator | FDES103<br>(ED403)<br>EMS<br>Stimulator | |
| Treatment area | | | Any area (Except those treatment area which<br>been described in the user manual can not<br>use), such as Hand, Arm, Chest, Waist,<br>Buttock, Thigh, Calf, Back and low back etc. | | | Any area (Except those treatment area<br>which been described in the user<br>manual can not use), such as Hand,<br>Arm, Chest, Waist, Buttock, Thigh, Calf,<br>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<br>Top-Rank 50*50mm, Transparent silica gel | | | Compliance with ISO 10993-1, provided<br>by Top-Rank 50*50mm, Transparent<br>silica gel | | | Same |
| Classificat<br>ion | Type of protection<br>against electric<br>shock | | Internally powered equipment | | | Internally powered equipment | | | Same |
| | Degree of<br>protection against<br>electric shock | | Type BF applied part | | | Type BF applied part | | | Same |
| | Device Class | | Class II | | | Class II | | | Same |
| Complian<br>ce with<br>Voluntary<br>Standards<br>? | 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<br>standards | | | Compliant with requirements of IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2 safety<br>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]<br>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<br>equivalence<br>determination |
| | | | R-C1 TENS<br>and EMS<br>Stimulator | R-E1<br>EMS<br>Stimulator | R-T1<br>TENS<br>Stimulator | FDES101<br>(ED401) TENS<br>and EMS<br>Stimulator | FDES102<br>(ED402) TENS<br>Stimulator | FDES103<br>(ED403) EMS<br>Stimulator | |
| Output Specifications | |…