Combo Electrotherapy Device

K231440 · Shenzhen Roundwhale Technology Co. , Ltd. · IPF · Nov 3, 2023 · Physical Medicine

Device Facts

• Record ID: K231440
• Device Name: Combo Electrotherapy Device
• Applicant: Shenzhen Roundwhale Technology Co. , Ltd.
• Product Code: IPF · Physical Medicine
• Decision Date: Nov 3, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Model:R-C101W: For TENS/IF/MIC mode 1. Symptomatic relief of chronic intractable pain 2. Post traumatic pain 3. Post surgical pain For EMS/RUSS 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 muscles to prevent venous thrombosis Model:R-C101A For TENS/IF mode 1) Symptomatic relief of chronic intractable pain. 2) Post traumatic pain. 3) Post surgical pain. For EMS/RUSS mode 1) Relaxation of muscle spasm. 2) Increase of 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 muscles to prevent venous thrombosis Model:R-C101B For TENS/IF mode 1. Symptomatic relief of chronic intractable pain 2. Post traumatic pain 3. Post surgical pain For EMS/RUSS 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 muscles to preventvenous thrombosis Model:R-C101E For IF mode 1. Symptomatic relief of chronic intractable pain 2. Post traumatic pain 3. Post surgical pain For RUSS 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 muscles to preventvenous thrombosis Model:R-C101H For TENS and IF mode 1) Symptomatic relief of chronic intractable pain. 2) Post traumatic pain. 3) Post surgical pain. Model:R-C101D For TENS mode 1. Symptomatic relief of chronic intractable pain 2. Post traumatic pain 3. Post surgical pain Model:R-C101G 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 muscles to preventvenous thrombosis

Device Story

Combo Electrotherapy Device delivers electrical stimulation to nerves and muscles via self-adhesive electrode pads. Device features two independent output channels; user-selectable pre-set or custom programs. Software controls waveform characteristics, output levels, and timing. Powered by internal 3.7V Li-ion battery; rechargeable via external power supply. Intended for prescription use in clinical or home environments. Healthcare providers or patients apply electrodes to skin; device generates electrical pulses to achieve therapeutic goals like pain relief or muscle stimulation. Output parameters (voltage, current, frequency, pulse width) are managed by the device's microprocessor to ensure safety and efficacy. Benefits include pain management and muscle function maintenance/recovery.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by non-clinical bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance testing for nerve and muscle stimulators (IEC 60601-2-10). Biocompatibility of accessories was previously cleared under K22252.

Technological Characteristics

Enclosure: ABS plastic. Energy source: 3.7V Li-ion battery. Output: 2 independent channels, constant current. Waveforms: Biphasic (TENS, EMS, IF, RUSS), Monophasic (MIC). Connectivity: Standalone, no external data connection. Software: Microprocessor-controlled. Sterilization: N/A (non-sterile). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11.

Indications for Use

Indicated for patients requiring symptomatic relief of chronic intractable, post-traumatic, or post-surgical pain (TENS/IF/MIC modes) or muscle rehabilitation including relaxation of spasms, increased local blood flow, prevention of disuse atrophy, muscle re-education, maintenance of range of motion, and post-surgical stimulation to prevent venous thrombosis (EMS/RUSS modes).

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

• Combo Stimulator LT7102 (K171978)

Submission Summary (Full Text)

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November 3, 2023

Shenzhen Roundwhale Technology Co., Ltd. Amos Zou RA Manager 202.2/F.Building 27, Dafa Industrial Park, Longxi community, Longgang street, Longgang district Shenzhen, Guangdong 518108 China

Re: K231440

Trade/Device Name: Combo Electrotherapy Device Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF, GZJ, LIH Dated: September 27, 2023 Received: September 27, 2023

Dear Amos Zou:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Jitendra V. Virani -S

CDR Jitendra Virani, MS, MBA Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices

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Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K231440

Device Name Combo Electrotherapy Device

# Indications for Use (Describe)

Model:R-C101W:

- For TENS/IF/MIC mode
- 1. Symptomatic relief of chronic intractable pain
- 2. Post traumatic pain
- 3. Post surgical pain
- For EMS/RUSS 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 muscles to prevent venous thrombosis

#### Model:R-C101A

- For TENS/IF mode
- 1) Symptomatic relief of chronic intractable pain.
- 2) Post traumatic pain.
- 3) Post surgical pain.
- For EMS/RUSS mode
- 1) Relaxation of muscle spasm.
- 2) Increase of 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 muscles to prevent venous thrombosis

#### Model:R-C101B

For TENS/IF mode

- 1. Symptomatic relief of chronic intractable pain
- 2. Post traumatic pain
- 3. Post surgical pain
- For EMS/RUSS 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 muscles to preventvenous thrombosis

# Model:R-C101E

#### For IF mode

- 1. Symptomatic relief of chronic intractable pain
- 2. Post traumatic pain

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# 3. Post surgical pain

For RUSS 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 muscles to preventvenous thrombosis

# Model:R-C101H

For TENS and IF mode

- 1) Symptomatic relief of chronic intractable pain.
- 2) Post traumatic pain.
- 3) Post surgical pain.

## Model:R-C101D

For TENS mode

- 1. Symptomatic relief of chronic intractable pain
- 2. Post traumatic pain
- 3. Post surgical pain

# Model:R-C101G

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 muscles to preventvenous thrombosis

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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# Traditional 510(k) Summary

# 510(k) number: K231440

#### Submitter of 510(K): 1.

| Sponsor | |
|-------------------|----------------------------------------------------------------------------------------------------------------------|
| Company Name: | Shenzhen Roundwhale Technology Co., Ltd. |
| Address: | 202,2/F,Building 27, Dafa Industrial Park, Longxi community, Longgang<br>street, Longgang district, Shenzhen, China. |
| Contact person: | Zeng Chunming |
| TEL: | [phone] |
| FAX: | [phone] |
| E-mail: | [e-mail] |
| Date of Prepared: | November.01,2023 |

# Application Correspondent:

| Company Name: | Shenzhen Roundwhale Technology Co., Ltd. |
|-----------------|-------------------------------------------------------------------------------------------------------------------|
| Address: | 202,2/F,Building 27, Dafa Industrial Park, Longxi community, Longgang street, Longgang district, Shenzhen, China. |
| Contact person: | Amos Zou |
| TEL: | [phone] |
| E-mail: | [e-mail] |

#### 2. Proposed Device and code:

| Device name: | Combo Electrotherapy Device |
|--------------------------|---------------------------------------------------------|
| Model: | R-C101W,R-C101A,R-C101B,R-C101E,R-C101H,R-C101D,R-C101G |
| Primary Product Code: | IPF |
| Secondary Product Codes: | GZJ, LIH |
| Regulation number: | 1) 21 CFR 890.5850 |
| | 2) 21 CFR 882.5890 |
| | 3) 21 CFR 882.5890 |

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| Regulation Name: | 1) Powered muscle stimulator<br>2) Transcutaneous electrical nerve stimulator for pain relief<br>3) Transcutaneous electrical nerve stimulator for pain relief |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Review panel: | 1) Physical Medicine<br>2) Neurology<br>3) Neurology |
| Device class: | II |
| Type: | Traditional |

#### Predicate Device: 3.

| 510(K) | Trade or Proprietary or Model Name | Manufacturer | Product Code |
|---------|------------------------------------|-----------------------------------------|--------------|
| K171978 | Combo Stimulator LT7102 | Shenzhen Dongdixin Technology Co., Ltd. | IPF,ZJ, LIH |

#### 4. Description of Proposed Device:

The Combo Electrotherapy Device (Models: R-C101W, R-C101B, R-C101E, R-C101H, R-C101D, and R-C101G) is a Transcutaneous Electrical Nerve Stimulator. The device features two independent output chamels and four selfadhesive electrode gel pads. The stimulator sends a gentle electrical current to the underlying nerves and muscle groups via electrodes applied on the skin. Users can choose from pre-set programs or specify their own to suit their individual needs. All controls and indicators are controlled by software which also controls waveform characteristics.

The 7 models have similar housing with a viewable LCD display and an accessible keypad. The LCD is located on the upper half of the rectangular face of the device above the keypad. It is used to display system information to the user.

The device is battery-powered but can be connected to an external power supply its internal battery which is a non-user serviceable or accessible 3.7V D.C., Li-ion battery.

There are only two external connections on the device - power input and electrode connector - with no connection to any other devices. The Battery Charger is not included in the package; however, users can choose adapters that meet IEC 60601-1 medical stardards.

All of the accessories for use with this device are already marketed in the U.S. and are either Class II 510(k) exempt or Class II previously cleared devices. The accessories Include the following:

- The self-adhesive electrode (50mm x 50mm) with conductive media (gel) and Electrode Lead Wires is a Class II device that has ● been previously cleared (K2222,manufacturer: Shenzhen Roundwhale Technology Co., Ltd.). It can be packaged together with 510(k) cleared devices or separately as a replacement electrode for 510(k) cleared devices. The exact proportions of the ingredients used in the electrode patch/pad may be withheld as a trade secret.
- The electrode cable is a device composed of strands of insulated electrical conductors laid together around a central core and intended for medical purposes to connect an electrode from a patient to a diagnostic machine.(Submission Type:510(K) Exempt)
- USB Cable Is not a medical device, used to connect the external power supply to charge the lithium battery, The Battery Charger is not provided in the package, but users will choose adapters that meet the IEC 60601-1 medical standard. The accessories can be packaged with 510(k) cleared devices or packaged separately as a replacement electrode for 510(k)

| 110 00000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000<br>cleared devices. | | | | | | | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------|---------|---------|---------|---------|---------|--|--|
| model | R-C101W | R-C101A | R-C101B | R-C101E | R-C101H | R-C101D | R-C101G | | |

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| | TENS | TENS | TENS | RUSS | TENS | TENS | TENS |
|------|------|------|------|------|------|------|------|
| | EMS | EMS | EMS | IF | IF | | EMS |
| mode | RUSS | RUSS | RUSS | | | | |
| | MIC | IF | IF | | | | |
| | IF | | | | | | |

#### Indications for Use ട്.

#### Model:R-C101W:

For TENS/IF/MIC mode

- 1. Symptomatic relief of chronic intractable pain
- 2. Post traumatic pain
- 3. Post surgical pain

#### For EMS/RUSS 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 muscles to prevent venous thrombosis

#### Model:R-C101A

#### For TENS/IF mode

- 1) Symptomatic relief of chronic intractable pain.
- 2) Post traumatic pain.
- 3) Post surgical pain.
- For EMS/RUSS mode
- 1) Relaxation of muscle spasm.
- 2) Increase of 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 muscles to prevent venous thrombosis

#### Model:R-C101B

#### For TENS/IF mode

- 1. Symptomatic relief of chronic intractable pain
- 2. Post traumatic pain
- 3. Post surgical pain
- For EMS/RUSS 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 muscles to prevent venous thrombosis

Model:R-C101E For IF mode

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- 1. Symptomatic relief of chronic intractable pain
- 2. Post traumatic pain
- 3. Post surgical pain
- For RUSS 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 muscles to prevent venous thrombosis

## Model:R-C101H

For TENS and IF mode

- 1) Symptomatic relief of chronic intractable pain.
- 2) Post traumatic pain.
- 3) Post surgical pain.

## Model:R-C101D

For TENS mode

- 1. Symptomatic relief of chronic intractable pain
- 2. Post traumatic pain
- 3. Post surgical pain

## Model:R-C101G

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 muscles to prevent venous thrombosis

#### 6. Technical and Performance

The following table compares the device to the predicate device with basic technological characteristics.

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| No. | Item | Predicate device (K171978) | New device (K231440) | Discussion |
|-----|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Device Name | Combo Stimulator LT7102 | Combo Electrotherapy Device (Model:R-<br>C101W,R-C101A,R-C101B,R-C101E,R-<br>C101H,R-<br>C101D,R-C101G) | N/A |
| 2 | Manufacturer | Shenzhen Dongdixin TechnologyCo., Ltd. | Shenzhen Roundwhale TechnologyCo., Ltd. | N/A |
| 3 | Type of use | Prescription | Prescription | Same |
| 4 | Indications for<br>Use | Combo Stimulator LT7102<br>For TENS/IF/MIC mode<br>1. Symptomatic relief of chronic intractable pain<br>2. Post traumatic pain<br>3. Post surgical pain<br>For EMS/RUSS mode<br>1. Relaxation of muscle spasm.<br>2. Increase of local blood flowcirculation<br>3. Prevention or retardation ofdisuse atrophy<br>4. Muscle re-education<br>5. Maintaining or increasing rangeof motion.<br>6. Immediate post-surgical stimulation of<br>muscles to prevent venous thrombosis | Model:R-C101W:<br>For TENS/IF/MIC mode<br>1. Symptomatic relief of chronic intractable pain<br>2. Post traumatic pain<br>3. Post surgical pain<br>For EMS/RUSS mode<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 muscles<br>to prevent venous thrombosis<br>Model:R-C101A<br>For TENS/IF mode<br>1. Symptomatic relief of chronic intractable pain.<br>2. Post traumatic pain.<br>3. Post surgical pain.<br>For EMS/RUSS mode<br>1) Relaxation of muscle spasm.<br>2) Increase of blood flow circulation.<br>3) Prevention or retardation of disuse atrophy.<br>4) Muscle re-education.<br>5) Maintaining or increasing range of motion. | Same |
| No. | Item | Predicate device (K171978) | New device (K231440) | Discussion |
| | | | prevent venous thrombosis | |
| | | | | |
| | | | Model:R-C101B | |
| | | | For TENS/IF mode | |
| | | | 1. Symptomatic relief of chronic intractable pain | |
| | | | 2. Post traumatic pain | |
| | | | 3. Post surgical pain | |
| | | | For EMS/RUSS 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 muscles to | |
| | | | prevent venous thrombosis | |
| | | | Model:R-C101E | |
| | | | For IF mode | |
| | | | 1. Symptomatic relief of chronic intractable pain | |
| | | | 2. Post traumatic pain | |
| | | | 3. Post surgical pain | |
| | | | For RUSS 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 muscles to | |
| | | | prevent venous thrombosis…