K Number

Device Name

Manufacturer

Shenzhen Roundwhale Technology Co., Ltd.

Date Cleared

2023-11-03

(169 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K171978

Predicate For

N/A

Intended Use

Model:R-C101W:

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

Model:R-C101A

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

Model:R-C101B
For TENS/IF mode

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

Model:R-C101E
For IF mode

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

Model:R-C101H
For TENS and IF mode

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

Model:R-C101D
For TENS mode

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

Model:R-C101G
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.

Immediate post-surgical stimulation of muscles to prevent venous thrombosis

Device Description

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 channels 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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a "Combo Electrotherapy Device." It establishes substantial equivalence to a predicate device, K171978. The document primarily focuses on non-clinical performance and safety data, as no clinical data was performed.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely based on demonstrating equivalence to the predicate device (K171978) in technical characteristics and compliance with relevant safety standards. The reported device performance is presented as a comparison to the predicate device.

Acceptance Criteria Category	Specific Criteria (Implicitly based on Predicate Device)	Reported Device Performance (New Device K231440)	Discussion
Indications for Use	Same indications as predicate: Symptomatic relief of chronic intractable pain, post-traumatic pain, post-surgical pain (TENS/IF/MIC); Relaxation of muscle spasm, increased local blood flow, prevention/retardation of disuse atrophy, muscle re-education, maintaining/increasing range of motion, immediate post-surgical stimulation to prevent venous thrombosis (EMS/RUSS).	Primarily the same across all models (R-C101W, R-C101A, R-C101B, R-C101E, R-C101H, R-C101D, R-C101G), with some models having subsets of the modes. For example, R-C101E only has IF and RUSS modes for the specified indications.	Same. The document states, "The proposed device has the same intended use... as the predicate device." While some models have fewer modes, the indications for the available modes are identical.
Power Source	3.7V Li-ion Battery Charger output: 5.0V DC, 300mA	3.7 V Li-ion battery Charger Output: 5V DC, 300mA	Same.
Patient Leakage Current	Normal condition: 5 uA; Single fault condition: 5 uA	Normal condition: 5 uA; Single fault condition: 5 uA	Same.
Number of Output Channels	2	2	Same.
Channel Isolation	By enclosure	By enclosure	Same.
Current/Voltage Control	Constant Current: Yes; Constant Voltage: No	Constant Current: Yes; Constant Voltage: No	Same.
Software/Firmware Control	Yes	Yes	Same.
Safety Features	Automatic Overload Trip: Yes; Automatic Over Current Trip: Yes; Automatic No-Load Trip: Yes; Automatic Shut-off: Yes; Patient Override Control: No	All "Yes" for trip/shut-off features, "No" for patient override control.	Same.
Indicator Display	On/Off Status: Yes; Voltage/Current Level: Yes; Low Battery: Yes	All "Yes".	Same.
Waveform Type	Biphasic for TENS, EMS, Interferential, Russian; Monophasic for Microcurrent. Shapes are all Square.	Bi-phase for all except MIC (Mono-phase). All shapes are Square.	Same.
Max Output Voltage (V) ±20% (Various Loads)	Ranges provided for Predicate (e.g., TENS 500Ω: 50V, 2kΩ: 102V)	Ranges provided for New Device (e.g., TENS 500Ω: 45V, 2kΩ: 96V).	Different, but the discussion notes these parameters passed IEC 60601-2-10 tests and do not exceed safety limits (calculated max current density and average power density). No new safety/effectiveness issues.
Max Output Current (mA) ±20% (Various Loads)	Ranges provided for Predicate (e.g., TENS 500Ω: 100mA, 2kΩ: 51mA)	Ranges provided for New Device (e.g., TENS 500Ω: 90mA, 2kΩ: 48mA).	Different, but the discussion notes these parameters passed IEC 60601-2-10 tests and do not exceed safety limits (calculated max current density and average power density). No new safety/effectiveness issues.
Pulse Width Range	Ranges provided for Predicate (e.g., TENS: 50-400uS; EMS: 200~400uS)	Ranges provided for New Device (e.g., TENS/EMS: 50 to 450 μs; IF: 50µs/100µs; MIC: 2ms - 500ms; RUSS: 200μs).	Different, but noted as minor and compliant with 60601-2-10, thus not raising safety/effectiveness issues.
Frequency Range	Ranges provided for Predicate (e.g., TENS: 1~~150Hz; EMS: 1~~100Hz)	Ranges provided for New Device (e.g., TENS/EMS: 2 to 150 Hz; IF Carrier F 5KHz/10KHz Beat F1Hz -200Hz; MIC: 0.1Hz - 150Hz; RUSS Carrier F 2.5KHz Burst F10Hz -70Hz).	Different, but noted as minor and compliant with 60601-2-10, thus not raising safety/effectiveness issues.
Beat Frequency (IF)	1-200Hz	1-200Hz	Same.
Maximum Phase Charge (uC, 500Ω)	TENS: 2.40; EMS: 2.40; IF: 0.79; MIC: 0.48; RUSS: 3.5	TENS: 2.73; EMS: 2.73; IF: 0.75; MIC: 0.42; RUSS: 9	Different, but stated to have passed IEC 60601-2-10 tests and safety limits (current density < 2 mA/cm², power density < 0.25 W/cm²). No new safety/effectiveness issues.
Maximum Current Density (mA/cm², 500Ω, r.m.s)	TENS: 0.24; EMS: 0.24; IF: 0.63; MIC: 0.01; RUSS: 0.7	TENS: 0.24; EMS: 0.24; IF: 0.6; MIC: 0.01; RUSS: 1.8	Mostly similar or within acceptable limits. The RUSS mode is higher but within the stated IEC limit of <2 mA/cm².
Maximum Average Current (mA)	TENS: 6; EMS: 6; IF: 15.75; MIC: 0.24; RUSS: 17.5	TENS: 6.075; EMS: 6.075; IF: 15; MIC: 0.21; RUSS: 45	Different, explained by calculations showing compliance with safety limits. RUSS is significantly higher but justified by remaining within safety limits (Note 3).
Maximum Power Density (mW/cm², 500Ω, r.m.s)	TENS: 0.72; EMS: 0.72; IF: 4.96; MIC: 0.01; RUSS: 6.13	TENS: 0.74; EMS: 0.74; IF: 4.5; MIC: 0.01; RUSS: 40.5	Different, explained by calculations showing compliance with safety limits. RUSS is significantly higher but justified by remaining within safety limits (<0.25 W/cm² Guidance Document).
ON/OFF Time	Not publicly available for predicate.	TENS: N/A; EMS: 1-90 S; IF: N/A; MIC: N/A; RUSS: 1-90 S.	Different from predicate (likely), but compliant with FDA Guidance Document and not impacting safety/effectiveness.
Electrode Area (cm²)	25	25	Same.
Timer Range (minutes)	5-90 minutes	5-90 minutes	Same.
Compliance with Voluntary Standards	IEC60601-1, IEC60601-1-2, IEC60601-2-10	IEC60601-1, IEC60601-1-2, IEC60601-2-10	Same.
Compliance with 21 CFR 898	Yes	Yes	Same.
Weight (lbs.)	0.28	About 140 grams (0.31lbs)	Different, but noted as not raising different questions of safety & effectiveness.
Dimensions H x W x L	4.6x2.36x0.9 inch	120.5 mm (L) x 69.5 mm (W) x 27mm (H)	Different, but noted as not raising different questions of safety & effectiveness.
Housing Materials & Construction	Enclosure: ABS	Enclosure: ABS	Same.
Burst Mode Characteristics	Not publicly available for predicate.	TENS: Pulses per burst: 7; Bursts per second: 0.5, 1, 2, 3, 4, 5; Burst duration: 70mS; Duty Cycle: 3.5% - 35%. Other modes N/A for these parameters.	Different from predicate (likely), but noted as not adversely impacting safety and effectiveness.
Accessories	All listed accessories (electrode, conductive medium, lead wires, batteries) are the same as predicate. Battery charger not included.	All listed accessories (self-adhesive electrode (50mm x 50mm), conductive media (gel), electrode lead wires, 3.7V D.C., Li-ion batteries) are the same as predicate. Battery charger not provided.	Same. The electrodes are explicitly stated to have been previously cleared (K22252, same manufacturer).
Biocompatibility	Acceptable for skin contact.	The same Self-Adhesive Electrode (K22252) used for the device was evaluated based on ISO10993 for intact skin contact (max 10-15 uses) and submitted to FDA.	Met. Reference to existing cleared accessories and ISO10993 compliance.
Electrical Safety and EMC	Compliance with IEC 60601-1:2012 and IEC 60601-1-2:2014.	The system complies with IEC 60601-1: 2012 and IEC 60601-1-2: 2014 standards.	Met. Testing conducted and compliance confirmed.
Bench Testing	Compliance with IEC 60601-1-11:2015 and IEC 60601-2-10:2016.	The system complies with IEC 60601-1-11: 2015 and IEC 60601-2-10: 2016 standards.	Met. Testing conducted and compliance confirmed.
Software Verification and Validation	Compliance with FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" for "Moderate" level of concern.	Software verification and validation testing conducted, documentation provided as recommended by FDA guidance. Software considered "Moderate" level of concern.	Met. V&V conducted and documented per FDA guidance.

Study Proving Acceptance Criteria:

The studies proving the device meets the acceptance criteria are non-clinical tests, as indicated in Section 7 of the 510(k) summary: "No clinical testing was performed."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify a quantitative sample size for the "test set" in terms of number of devices or data points beyond stating that "Non-clinical tests were conducted to verify that the proposed device met all design specifications." The testing appears to be primarily laboratory-based bench testing on the device itself.
Data Provenance: The data provenance is from bench testing and laboratory evaluations conducted by the manufacturer, Shenzhen Roundwhale Technology Co., Ltd. (China), or their contracted testing facilities. It is not retrospective or prospective clinical data in the traditional sense, as no clinical studies were performed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable in the context of this 510(k) submission. The ground truth for electrical muscle stimulators in a 510(k) premarket notification is established through:
* Comparison to a legally marketed predicate device.
* Adherence to recognized safety and performance standards (e.g., IEC 60601 series).
* Bench testing to demonstrate the device performs according to its specifications and within acceptable safety limits.

There are no "experts" establishing a "ground truth" on patient data for this type of submission because no clinical data was submitted.

4. Adjudication Method for the Test Set

Not applicable. Since no clinical data or expert evaluations of patient outcomes were performed, there is no need for an adjudication method. The compliance is demonstrated via engineering and safety tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a powered muscle stimulator/TENS unit, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance is irrelevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable in the context of AI/algorithms affecting diagnostic performance. While the device does contain software/firmware (item 9 in the comparison table indicates "Software/Firmware/Microprocessor Control? Yes"), the performance testing detailed (Section 7) is related to the device's electrical safety, EMC, and bench performance according to standards, not the diagnostic accuracy of an algorithm. The software verification and validation are for the operational integrity and safety of the device's control system, not for an independent diagnostic capability.

7. The Type of Ground Truth Used

The ground truth for this submission is established by:
* Predicate Device Equivalence: The primary ground truth is the performance and safety profile of the legally marketed predicate device (K171978). The new device aims to be substantially equivalent in design and performance.
* Consensus Standards: Adherence to recognized national and international consensus standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10). These standards define acceptable performance and safety limits for such devices.
* Bench Test Results: Direct measurements and calculations from bench testing that demonstrate the device's electrical characteristics (output voltage, current, pulse width, frequency, current density, power density, etc.) remain within acceptable limits defined by the standards and are comparable to the predicate.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning model that requires a training set of data. The "training" of this device refers to its engineering design and manufacturing to meet specified parameters.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As stated above, there is no "training set" for this type of medical device submission.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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"

{1}------------------------------------------------

(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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{2}------------------------------------------------

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

Enclosure

{3}------------------------------------------------

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
1. Post traumatic pain
1. Post surgical pain
For EMS/RUSS 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 muscles to prevent venous thrombosis

Model:R-C101A

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

Model:R-C101B

For TENS/IF mode

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

Model:R-C101E

For IF mode

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

{4}------------------------------------------------

3. Post surgical pain

For RUSS 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 muscles to preventvenous thrombosis

Model:R-C101H

For TENS and IF mode

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

Model:R-C101D

For TENS mode

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

Model:R-C101G

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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{5}------------------------------------------------

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, Longgangstreet, Longgang district, Shenzhen, China.
Contact person:	Zeng Chunming
TEL:	+86-755-23212776
FAX:	+86-755-23212776
E-mail:	zcm@roovjoy.com
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:	+86-15015249549
E-mail:	amos.zou@139.com

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

{6}------------------------------------------------

Regulation Name:	1) Powered muscle stimulator2) Transcutaneous electrical nerve stimulator for pain relief3) Transcutaneous electrical nerve stimulator for pain relief
Review panel:	1) Physical Medicine2) Neurology3) 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 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 00000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000cleared devices.
model	R-C101W	R-C101A	R-C101B	R-C101E	R-C101H	R-C101D	R-C101G

{7}------------------------------------------------

	TENS	TENS	TENS	RUSS	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
1. Post traumatic pain
1. Post surgical pain

For EMS/RUSS 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 muscles to prevent venous thrombosis

Model:R-C101A

For TENS/IF mode

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

Model:R-C101B

For TENS/IF mode

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

Model:R-C101E For IF mode

{8}------------------------------------------------

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

Model:R-C101H

For TENS and IF mode

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

Model:R-C101D

For TENS mode

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

Model:R-C101G

For TENS mode

1. Symptomatic relief of chronic intractable pain.
2.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

Muscle re-education

1. Maintaining or increasing range of motion.

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.

{9}------------------------------------------------

No.	Item	Predicate device (K171978)	New device (K231440)	Discussion
1	Device Name	Combo Stimulator LT7102	Combo Electrotherapy Device (Model:R-C101W,R-C101A,R-C101B,R-C101E,R-C101H,R-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 forUse	Combo Stimulator LT7102For TENS/IF/MIC mode1. Symptomatic relief of chronic intractable pain2. Post traumatic pain3. Post surgical painFor EMS/RUSS mode1. Relaxation of muscle spasm.2. Increase of local blood flowcirculation3. Prevention or retardation ofdisuse atrophy4. Muscle re-education5. Maintaining or increasing rangeof motion.6. Immediate post-surgical stimulation ofmuscles to prevent venous thrombosis	Model:R-C101W:For TENS/IF/MIC mode1. Symptomatic relief of chronic intractable pain2. Post traumatic pain3. Post surgical painFor EMS/RUSS mode1. Relaxation of muscle spasm.2. Increase of local blood flow circulation3. Prevention or retardation of disuse atrophy4. Muscle re-education5. Maintaining or increasing range of motion.6. Immediate post-surgical stimulation of musclesto prevent venous thrombosisModel:R-C101AFor TENS/IF mode1. Symptomatic relief of chronic intractable pain.2. Post traumatic pain.3. Post surgical pain.For EMS/RUSS mode1) 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.	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

			Model:R-C101H
			For TENS and IF mode
			1. Symptomatic relief of chronic intractable pain.
			2. Post traumatic pain.
			3. Post surgical pain
No.	Item	Predicate device (K171978)	New device (K231440)	Discussion
			Model:R-C101DFor TENS mode1. Symptomatic relief of chronic intractable pain2. Post traumatic pain3. Post surgical painModel:R-C101GFor TENS mode1) Symptomatic relief of chronic intractable pain.2) Post traumatic pain.3) Post surgical pain.For EMS mode1. Relaxation of muscle spasm.2. Increase of local blood flow circulation3. Prevention or retardation of disuse atrophy4. Muscle re-education5. Maintaining or increasing range of motion.6. Immediate post-surgical stimulation of muscles toprevent venous thrombosis
5	Power Source	3.7V Li-ion Battery Charger output: 5.0V DC,300mA	3.7 V Li-ion batteryCharger Output: 5V DC, 300mA	Same
	Method of Linecurrentisolation	N/A	NA	Same
	-Patient LeakageCurrent-Normal condition-Single faultcondition	5 uA5 uA	5 uA5 uA	Same
No.	Item	Predicate device (K171978)	New device (K231440)	Discussion
6	Number ofOutput Modes	5	R-C101W:TEN/EMS/IF/RUSS/MICRC101A:TENS/EMS/RUSS/IFR-C101B:TENS/EMS/RUSS/IFR-C101E:RUSS/IFR-C101H:TENS/IFR-C101D:TENSR-C101G:TENS/EMS	DifferentNote 1The number of treatment programs onlydifferent by design; the core principles ofthese two devices are similar but does notadversely impact safety and effectiveness ofsubject device.
7	Number ofOutputChannels	2	2	Same
UN	- SynchronousorAlternating?	Synchronous andAlternating	Synchronous andAlternating	Same
	- Method ofChannelIsolation?	By enclosure	By enclosure	Same
8	ConstantCurrent?ConstantVoltage?	YesNo	YesNo	Same
9	Software/Firmware/Microprocessor Control?	Yes	Yes	Same
10	AutomaticOverload Trip?Automatic OverCurrentTrip?	Yes	Yes	Same
11	Automatic NoLoadTrip?	Yes	Yes	Same
12	AutomaticShutoff?	Yes	Yes	Same
13	PatientOverrideControl?	No	No	Same
14	Indicator Display
No.	Item	Predicate device (K171978)	New device (K231440)	Discussion
	-On/OffStatus?	Yes	Yes	Same
	-Voltage/CurrentLevel?	Yes	Yes	Same
	-Low Battery?	Yes	Yes	Same
15	WaveformTENS EMSInterferentialMicrocurrentRussian	Biphasic BiphasicBiphasic MonophasicBiphasic	MIC : Mono-phaseOther : Bi-phase	Same
16	ShapeTENSEMSInterferentialMicrocurrentRussian	SquareSquareSquareSquareSquare	SquareSquareSquareSquareSquare	Same
17	Max Output Voltage (V) ±20%
	500ΩTENSEMSInterferentialMicrocurrentRussian	505015.750.415.75	4545150.3545	DifferentNote 2Based on the calculation refer Note 3 ofmaximum current density, maximumaverage power density , these parametersdon't exceed the safety limit. and theseparameters have passed IEC 60601-2-10test codes. So these differences will notraise any new safety and effectivenessissues.
	2kΩTENSEMSInterferentialMicrocurrentRussian	102102331.633	9696301.4894
	10kΩTENSEMSInterferentialMicrocurrentRussian	Not publicly available	9696301.4894
18	Max Output Current (mA) ±20%
No.	Item	Predicate device (K171978)	New device (K231440)	Discussion
	500ΩTENSEMSInterferentialMicrocurrentRussian	10010031.50.831.5	9090300.790	DifferentNote 2Based on the calculation refer Note 3 ofmaximum current density, maximumaverage power density , these parametersdon't exceed the safety limit. and theseparameters have passed IEC 60601-2-10test codes. So these differences will notraise any new safety and effectivenessissues.
	2kΩTENSEMSInterferentialMicrocurrentRussian	515116.50.816.5	4848150.7447
	10kΩTENSEMSInterferentialMicrocurrentRussian	Not publicly available	9.69.630.1489.4
19	Pulse WidthRange TENSEMSInterferentialMicrocurrentRussian	TENS:50-400uSEMS:200~400uSIF:100/200/400uS MIC:2-200msRUSS:400uS	TENS/EMS: 50 to 450 μs ;IF:50µs/100µs ; MIC: 2ms -500msRUSS: 200μs
20	FrequencyTENS EMSInterferentialMicrocurrentRussian	TENS:1~~150Hz EMS:1~~100HzIF:2.5K,5K,10K HzMIC:1-150HzRUSS:2.5kHz	TENS/EMS: 2 to 150 Hz ;IF: Carrier F 5KHz/10KHz Beat F1Hz -200HzMIC: 0.1Hz - 150HzRUSS: Carrier F 2.5KHz Burst F10Hz -70Hz
21	BeatFrequencyInterferential	1-200Hz	1-200Hz	Same
22	Maximum PhaseCharge (uC, 500Ω)	TENS:2.40EMS:2.40IF: 0.79MIC:0.48RUSS:3.5	TENS: 2.73EMS:2.73IF: 0.75MIC:0.42RUSS:9	DifferentNote 3have passed IEC 60601-2-10 test. theMaximum Current Density of the subjectdevice is lower than 2 mA/cm² refers to"IEC60601-2-10 Clause 201.4.2" and theMaximum Average Power Density is lessthan 0.25 W/cm² refer to "GuidanceDocument for Powered Muscle Stimulator510(k)s
	Maximum CurrentDensity (mA/cm2,500Ω, r.m.s)	TENS: 0.24EMS: 0.24IF:0.63MIC:0.01RUSS:0.7	TENS: 0.24EMS: 0.24IF:0.6MIC:0.01RUSS:1.8
No.	Item	Predicate device (K171978)	New device (K231440)	Discussion
	Net Charge (µC)per pulse	Not publicly available	TENS: 0 µC @500Ω Method: Balanced waveformEMS: 0 µC @500Ω Method: Balanced waveformIF: 0 µC @500Ω Method: Balanced waveformMIC: 0 µC @500Ω Method: Balanced waveformRUSS: 0 µC @500Ω Method: Balanced waveform
	Max.Average current(average absolutevalue, mA)	TENS: 6EMS: 6IF: 15.75MIC:0.24RUSS:17.5	TENS: 6.075EMS: 6.075IF:15MIC:0.21RUSS:45
	Maximum PowerDensity (mW / cm2,500Ω, r.m.s)	TENS: 0.72EMS: 0.72IF: 4.96MIC:0.01RUSS:6.13	TENS: 0.74EMS: 0.74IF: 4.5MIC:0.01RUSS:40.5
	ON Time	Not publicly available	TENS: N/AEMS: 1-90 SIF: N/AMIC: N/ARUSS:1-90 S	Although the "on/off" time is slightlydifferent for both devices it is compliantwith FDA Guidance Documentfor Powered Muscle Stimulator 510(k)sand the difference between on and off time
	OFF time	Not publicly available	TENS: N/AEMS: 1-90 SIF: N/AMIC: N/ARUSS: 1-90 S	ranges doesn't impactessential performance, basic safety orsubstantial equivalence.
23	Electrode area (cm2)	25	25	Same
24	Timer Range(minutes)	5-90 minutes	5-90 minutes	Same
25	CompliancewithVoluntaryStandards?	IEC60601-1, IEC60601-1-2,IEC60601-2-10	IEC60601-1, IEC60601-1-2,IEC60601-2-10	Same
26	Compliancewith21CFR 898?	Yes	Yes	Same
27	Weight (lbs.)	0.28	About 140 grams(0.31lbs)	Different,Note 4
28	Dimensions H xWxL	4.6x2.36x0.9 inch	120.5 mm (L) x 69.5 mm (W) x 27mm (H)	Differences in physical and electroniccomponent characteristics do not raisedifferent questions of safety &effectiveness.
No.	Item	Predicate device (K171978)	New device (K231440)	Discussion
29	HousingMaterials &Construction	Enclosure: ABS	Enclosure: ABS	Same
30	Burst Mode (i.e., pulse trains)
	a. Pulses per burst	Not publicly available	TENS: 7EMS: N/AIF: N/AMIC: N/ARUSS: N/A	Different but does not adversely impactsafety and effectiveness of subject device
	b. Bursts per second	Not publicly available	TENS: 0.5, 1, 2, 3, 4, 5EMS: N/AIF: N/AMIC: N/ARUSS: N/A
	c. Burst duration(seconds)	Not publicly available	TENS: 70mSEMS: N/AIF: N/AMIC: N/ARUSS: N/A
	d. Duty Cycle [Line (b)x Line (c)]	Not publicly available	TENS: 3.5% - 35%EMS: N/AIF: N/AMIC: N/ARUSS: N/A
31	Description of Accessories
	1. Electrodes	self-adhesive electrode (50mm x 50mm)	self-adhesive electrode (50mm x 50mm)	Same
	2. Electrode ConductiveMedium (Gel)	self-adhesive electrode with conductive media (gel)	self-adhesive electrode with conductive media (gel)	Same
	3. Electrode Lead Wiresand Patient Cables	self-adhesive electrode with Electrode Lead Wires	self-adhesive electrode with Electrode Lead Wires	Same
	4. Batteries	3.7V D.C.,Li-ion batteries	3.7V D.C.,Li-ion batteries	Same
	5. Battery Charger	NA	NA	Same

{10}------------------------------------------------

{11}------------------------------------------------

{12}------------------------------------------------

{13}------------------------------------------------

{14}------------------------------------------------

{15}------------------------------------------------

{16}------------------------------------------------

Comparison in Detail(s):

{17}------------------------------------------------

Note 1

The proosed device has nore treatment programs than the programs of proposed device are an omparable to the mode 1 to mode 1 to mode 1 to mode 1 to mode 1 to mode 1 to mode 1 The proosed device deatment program to ompare with the mode 6 of the predicate device beause predicate cerice's mode 4 to mode 6 are variation werelorn of the mode 1 to mode 3. All of the treatment programs lare HC (0601-2-10 and AMI / ANS ES6(00)-1 test oods. So this difference doesn't raise any safety or effectivenss issue. And the weight, dimensions, appearance of proposed device are a little different from predicate will not raise any sabely or effectivenss issue.

Note 2: Difference in Maximum Output Voltage and Maximum Output Current

There are some differences on the nasimum output current between the proposed device and predicate device. Based on the ealculation weet dessin, maximum aserage nover the significant in these prameters have nased IFC. 660 -2-10 tost poles, Sy hear one new saby and effectiveness issues. Although the pulse recol and frequency of the proposed device are a little different from the prodicate evive, but they are all compliance with 2-10 requirements. So, the minor differences of function specification will not raise any safety or effectiveness issue.

Note 3: Difference in maximum current density, maximum average current and maximum power density

under TENS mode, Select the maximum frequency with in TENS mode for calculation pulse width 450S. Frequency of Ship.

Maximum Average Current=I Peak FP=90150450*/1000000=6.075mA
Maximum Current Density: = I Peak FP/S= 6.075/ (5*5) =0.24mA/cm2
· Maximum Average Power Density=Maximum CurrentMaximum CurrentR /S=0.74mW/cm2

ander EMS mode, Select the maximum frequency and public 4500S, Frequency: 150 Hz, max ouput coment: 90m4, electroder: 90x3 , electroder: 90x3 , electroder: 90x3 , electrod

Maximum Average Current=I Peak FP=90150450/1000000=6.075mA
Maximum Current Density: = I Peak FP/S= 6.075/ (5*5) =0.24mA/cm2
· Maximum Average Power Density=Maximum CurrentMaximum CurrentR /S=0.74mW/cm2
1. under IF mote, Select the maximum frequency and public with. Stock in calculation: pulse with. Stock on the supert. 30mA, electrodes: 50 x 50mm
- Maximum Average Current=I Peak FP=30 * 10000 * 50*/1000000=15mA
- Maximum Current Density: =I Peak FP/S= 15/ (5*5) =0.6mA/cm2
- · Maximum Average Power Density=Maximum CurrentMaximum CurrentR /S=4.5mW/cm²
1. under RUSS node, Select the naximum frequency and pulse with: 2005, Frequency: 200 Hz, nax output current: 90m4, electroder: 90 x 51mm
- Maximum Average Current=I Peak FP=902500200/1000000=45mA
- Maximum Current Density: =I Peak FP/S= 45/ (5*5) =1.8mA/cm2
- · Maximum Average Power Density=Maximum CurrentMaximum CurrentR /S=40.5mW/cm2
1. under MC mode, Select the maximum frequency and public in TENS mode width: 2mS, Frequency: 150 Hz, max output current: 0.7mA, dectroder: 50 x 5 Umn
- Maximum Average Current=I Peak FP=0.715020000*/1000000=0.21mA
- Maximum Current Density: =I Peak FP/S= 0.21/(5*5)=0.01mA/cm2
- · Maximum Average Power Density=Maximum CurrentMaximum CurrentR /S=0.01mW/cm2

The proposed device and the predicate device in net charge, maximum current density, maximum power density, burst duration and duy over However, he not exceed the sufety imit and have passed EC 6060-2-10 est. the Maximum Current Density of the subject device is lover than 2 mAcm refers to "HC6(01-2-10 Clause 2014.2" and the Maximum Averge Pover Density is less than Cor Corlance Document for Powered Muscle Stimulator 500klor 500 kb (page 16 section 3 "Maximum current density and power censiny who salestive surface area of the smallest electrocs provided recommended for use with the unit, sample edulations stould be provided. The naximum power censity should be averaged over an output duration of one econd. The maximum power density should be less than 0.25 Watts/cm² to reduce the risk of thermal burns"Therefore, these differences will not pose any new safety or effectiveness risks.

Note 4 Weight and Dimensions

Differences in physical and electronic characteristics do not raise different questions of safety & effectiveness.

{18}------------------------------------------------

7. Performance Testing:

Test Summary:

To establish substantial equivalence to the identified predicate devices, we performed the following tests on the subject device, Combo Electrotherapy Device serials.The testing results provide evidence that the device complies with the applicable standards requirement and it is substantially equivalent to the predicate devices.

Performance data includes "Non-Clinical Data", brief description of which are shown as below.

7.1 Non-Clinical Data:

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrate that the proposed device complies with the following standards:

7.2 Biocompatibility testing

The new product Combo Electrotherapy Device (Model: R-C101A, R-C101B, R-C101E, R-C101E, R-C101H, R-C101D, R-C101G) has the same accessories-Self-Adhesive Electrode, it will have direct contact with human body only at intact skin, the maximum number of times the product can be used is 10-15 times. This information has been submitted by Shenzhen Roundwhale Technology Co., Ltd. (K22252), and it has been evaluated based on the ISO10993 standard and submitted to FDA.

7.3 Electrical Safety and EMC

Electrical safety and EMC testing were conducted on the Combo Electrotherapy Device (Model:R-C101W.R-C101A,R-C101B,R-C101E,R-C101H,R-C101D,R-C101G) ,, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-1: 2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety and the IEC 60601-1- 2: 2014 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests standard for EMC.

7.4 Bench Testing

Bench testing was conducted on the Combo Electrotherapy Device (Model:R-C101W,R-C101A,R-C101B,R-C101E,R-C101H,R-C101G),consisting of all the accessories in the system. The system complies with the IEC 60601-1-11: 2015 MEDICAL ELECTRICAL EQUIPMENT –Part 1-11: General requirements for basic safety and essential performance -Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment,and IEC 60601-2-10 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators (Edition 2.1 2016-04)

7.5 Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern.

8. Clinical data:

No clinical testing was performed

9. Conclusions:

The proposed device has the same intended use and similar characteristics as the predicate device, Meanwhile, performance testing, bench testing, and safety report documentation supplied in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness.

Roundwhale Ltd. maintains that the Combo Electrotherapy Device is substantially equivalent to the predicate device in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with international standards.

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).