(169 days)
Not Found
No
The description focuses on standard electrotherapy functions (TENS, EMS, IF, RUSS, MIC) and software control of waveform characteristics. There is no mention of AI, ML, or any adaptive or learning capabilities based on patient data or feedback. The performance studies are standard non-clinical tests for electrical safety, EMC, biocompatibility, and software verification/validation, not studies related to AI/ML performance metrics.
Yes
The device's intended uses, such as "symptomatic relief of chronic intractable pain," "relaxation of muscle spasm," and "prevention or retardation of disuse atrophy," directly address medical conditions or promote health, classifying it as a therapeutic device.
No
The device is a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS) designed for symptomatic relief of pain, muscle relaxation, increasing blood flow, preventing disuse atrophy, muscle re-education, and maintaining/increasing range of motion. Its intended uses are therapeutic (treatment) rather than diagnostic.
No
The device description explicitly states it is a "Combo Electrotherapy Device" with "two independent output channels and four selfadhesive electrode gel pads." It also mentions a physical housing, LCD display, keypad, battery, and external connections for power and electrodes. This indicates a physical hardware device that delivers electrical stimulation, not a software-only device. While software controls aspects of the device, it is integral to the hardware's function.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples from the human body. The intended use and device description clearly state that this device applies electrical stimulation to the skin over nerves and muscle groups. It does not collect or analyze any biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
- The intended uses are therapeutic. The listed indications for use are all related to treating symptoms (pain relief, muscle relaxation, preventing atrophy, etc.) through electrical stimulation. These are therapeutic applications, not diagnostic ones.
- The device description aligns with a therapeutic device. The description of the device as a Transcutaneous Electrical Nerve Stimulator (TENS) and its function of sending electrical current to nerves and muscles is consistent with a therapeutic device, not an IVD.
Therefore, this device falls under the category of a therapeutic medical device, specifically an electrotherapy device, rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Model:R-C101W:
- For TENS/IF/MIC mode
-
- Symptomatic relief of chronic intractable pain
-
- Post traumatic pain
-
- Post surgical pain
- For EMS/RUSS mode
-
- Relaxation of muscle spasm.
-
- Increase of local blood flow circulation
-
- Prevention or retardation of disuse atrophy
-
- Muscle re-education
-
- Maintaining or increasing range of motion.
-
- Immediate post-surgical stimulation of muscles to prevent venous thrombosis
Model:R-C101A
- For TENS/IF mode
-
- Symptomatic relief of chronic intractable pain.
-
- Post traumatic pain.
-
- Post surgical pain.
-
- For EMS/RUSS mode
-
- Relaxation of muscle spasm.
-
- Increase of blood flow circulation.
-
- Prevention or retardation of disuse atrophy.
-
- Muscle re-education.
-
- Maintaining or increasing range of motion.
-
- Immediate post-surgical stimulation of muscles to prevent venous thrombosis
-
Model:R-C101B
For TENS/IF mode
-
- Symptomatic relief of chronic intractable pain
-
- Post traumatic pain
-
- Post surgical pain
- For EMS/RUSS mode
-
- Relaxation of muscle spasm.
-
- Increase of local blood flow circulation
-
- Prevention or retardation of disuse atrophy
-
- Muscle re-education
-
- Maintaining or increasing range of motion.
-
- Immediate post-surgical stimulation of muscles to preventvenous thrombosis
Model:R-C101E
For IF mode
-
- Symptomatic relief of chronic intractable pain
-
- Post traumatic pain
-
- Post surgical pain
For RUSS mode
- Post surgical pain
-
- Relaxation of muscle spasm.
-
- Increase of local blood flow circulation
-
- Prevention or retardation of disuse atrophy
-
- Muscle re-education
-
- Maintaining or increasing range of motion.
-
- Immediate post-surgical stimulation of muscles to preventvenous thrombosis
Model:R-C101H
For TENS and IF mode
-
- Symptomatic relief of chronic intractable pain.
-
- Post traumatic pain.
-
- Post surgical pain.
Model:R-C101D
For TENS mode
-
- Symptomatic relief of chronic intractable pain
-
- Post traumatic pain
-
- Post surgical pain
Model:R-C101G
For TENS mode
-
- Symptomatic relief of chronic intractable pain.
-
- Post traumatic pain.
-
- Post surgical pain.
For EMS mode
- Post surgical pain.
-
- Relaxation of muscle spasm.
-
- Increase of local blood flow circulation
-
- Prevention or retardation of disuse atrophy
-
- Muscle re-education
-
- Maintaining or increasing range of motion.
- Immediate post-surgical stimulation of muscles to preventvenous thrombosis
Product codes (comma separated list FDA assigned to the subject device)
IPF, GZJ, LIH
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 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) cleared devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data includes "Non-Clinical Data", brief description of which are shown as below.
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:
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.
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.
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).
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.
No clinical testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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
-
- Symptomatic relief of chronic intractable pain
-
- Post traumatic pain
-
- Post surgical pain
- For EMS/RUSS mode
-
- Relaxation of muscle spasm.
-
- Increase of local blood flow circulation
-
- Prevention or retardation of disuse atrophy
-
- Muscle re-education
-
- Maintaining or increasing range of motion.
-
- Immediate post-surgical stimulation of muscles to prevent venous thrombosis
Model:R-C101A
- For TENS/IF mode
-
- Symptomatic relief of chronic intractable pain.
-
- Post traumatic pain.
-
- Post surgical pain.
-
- For EMS/RUSS mode
-
- Relaxation of muscle spasm.
-
- Increase of blood flow circulation.
-
- Prevention or retardation of disuse atrophy.
-
- Muscle re-education.
-
- Maintaining or increasing range of motion.
-
- Immediate post-surgical stimulation of muscles to prevent venous thrombosis
-
Model:R-C101B
For TENS/IF mode
-
- Symptomatic relief of chronic intractable pain
-
- Post traumatic pain
-
- Post surgical pain
- For EMS/RUSS mode
-
- Relaxation of muscle spasm.
-
- Increase of local blood flow circulation
-
- Prevention or retardation of disuse atrophy
-
- Muscle re-education
-
- Maintaining or increasing range of motion.
-
- Immediate post-surgical stimulation of muscles to preventvenous thrombosis
Model:R-C101E
For IF mode
-
- Symptomatic relief of chronic intractable pain
-
- Post traumatic pain
4
3. Post surgical pain
For RUSS mode
-
- Relaxation of muscle spasm.
-
- Increase of local blood flow circulation
-
- Prevention or retardation of disuse atrophy
-
- Muscle re-education
-
- Maintaining or increasing range of motion.
-
- Immediate post-surgical stimulation of muscles to preventvenous thrombosis
Model:R-C101H
For TENS and IF mode
-
- Symptomatic relief of chronic intractable pain.
-
- Post traumatic pain.
-
- Post surgical pain.
Model:R-C101D
For TENS mode
-
- Symptomatic relief of chronic intractable pain
-
- Post traumatic pain
-
- Post surgical pain
Model:R-C101G
For TENS mode
-
- Symptomatic relief of chronic intractable pain.
-
- Post traumatic pain.
-
- Post surgical pain.
For EMS mode
-
- Relaxation of muscle spasm.
-
- Increase of local blood flow circulation
-
- Prevention or retardation of disuse atrophy
-
- Muscle re-education
-
- Maintaining or increasing range of motion.
- Immediate post-surgical stimulation of 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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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, Longgang |
| street, 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 stimulator
2) Transcutaneous electrical nerve stimulator for pain relief
3) Transcutaneous electrical nerve stimulator for pain relief |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Review panel: | 1) Physical Medicine
2) Neurology
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
| cleared devices. | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| model | R-C101W | R-C101A | R-C101B | R-C101E | R-C101H | R-C101D | R-C101G |
7
| 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
-
- Symptomatic relief of chronic intractable pain
-
- Post traumatic pain
-
- Post surgical pain
For EMS/RUSS mode
-
- Relaxation of muscle spasm.
-
- Increase of local blood flow circulation
-
- Prevention or retardation of disuse atrophy
-
- Muscle re-education
-
- Maintaining or increasing range of motion.
-
- Immediate post-surgical stimulation of muscles to prevent venous thrombosis
Model:R-C101A
For TENS/IF mode
-
- Symptomatic relief of chronic intractable pain.
-
- Post traumatic pain.
-
- Post surgical pain.
- For EMS/RUSS mode
-
- Relaxation of muscle spasm.
-
- Increase of blood flow circulation.
-
- Prevention or retardation of disuse atrophy.
-
- Muscle re-education.
-
- Maintaining or increasing range of motion.
-
- Immediate post-surgical stimulation of muscles to prevent venous thrombosis
-
Model:R-C101B
For TENS/IF mode
-
- Symptomatic relief of chronic intractable pain
-
- Post traumatic pain
-
- Post surgical pain
- For EMS/RUSS mode
-
- Relaxation of muscle spasm.
-
- Increase of local blood flow circulation
-
- Prevention or retardation of disuse atrophy
-
- Muscle re-education
-
- Maintaining or increasing range of motion.
-
- Immediate post-surgical stimulation of muscles to prevent venous thrombosis
Model:R-C101E For IF mode
8
-
- Symptomatic relief of chronic intractable pain
-
- Post traumatic pain
-
- Post surgical pain
- For RUSS mode
-
- Relaxation of muscle spasm.
-
- Increase of local blood flow circulation
-
- Prevention or retardation of disuse atrophy
-
- Muscle re-education
-
- Maintaining or increasing range of motion.
-
- Immediate post-surgical stimulation of muscles to prevent venous thrombosis
Model:R-C101H
For TENS and IF mode
-
- Symptomatic relief of chronic intractable pain.
-
- Post traumatic pain.
-
- Post surgical pain.
Model:R-C101D
For TENS mode
-
- Symptomatic relief of chronic intractable pain
-
- Post traumatic pain
-
- Post surgical pain
Model:R-C101G
For TENS mode
-
- Symptomatic relief of chronic intractable pain.
- 2.Post traumatic pain.
-
- Post surgical pain.
For EMS mode
-
- Relaxation of muscle spasm.
-
- Increase of local blood flow circulation
-
- Prevention or retardation of disuse atrophy
- Muscle re-education
-
- Maintaining or increasing range of motion.
- Immediate post-surgical stimulation of 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 for | |||
| Use | Combo Stimulator LT7102 | |||
| For TENS/IF/MIC mode |
- Symptomatic relief of chronic intractable pain
- Post traumatic pain
- Post surgical pain
For EMS/RUSS mode - Relaxation of muscle spasm.
- Increase of local blood flowcirculation
- Prevention or retardation ofdisuse atrophy
- Muscle re-education
- Maintaining or increasing rangeof motion.
- Immediate post-surgical stimulation of
muscles to prevent venous thrombosis | Model:R-C101W:
For TENS/IF/MIC mode - Symptomatic relief of chronic intractable pain
- Post traumatic pain
- Post surgical pain
For EMS/RUSS mode - Relaxation of muscle spasm.
- Increase of local blood flow circulation
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Maintaining or increasing range of motion.
- Immediate post-surgical stimulation of muscles
to prevent venous thrombosis
Model:R-C101A
For TENS/IF mode - Symptomatic relief of chronic intractable pain.
- Post traumatic pain.
- Post surgical pain.
For EMS/RUSS mode
- Relaxation of muscle spasm.
- Increase of blood flow circulation.
- Prevention or retardation of disuse atrophy.
- Muscle re-education.
- 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-C101D
For TENS mode
- Symptomatic relief of chronic intractable pain
- Post traumatic pain
- Post surgical pain
Model:R-C101G
For TENS mode
- Symptomatic relief of chronic intractable pain.
- Post traumatic pain.
- Post surgical pain.
For EMS mode
- Relaxation of muscle spasm.
- Increase of local blood flow circulation
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Maintaining or increasing range of motion.
- Immediate post-surgical stimulation of muscles to
prevent venous thrombosis | |
| 5 | 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 |
| | Method of Line
current
isolation | N/A | NA | Same |
| | -Patient Leakage
Current
-Normal condition
-Single fault
condition | 5 uA
5 uA | 5 uA
5 uA | Same |
| No. | Item | Predicate device (K171978) | New device (K231440) | Discussion |
| 6 | Number of
Output Modes | 5 | R-C101W:TEN/EMS/IF/RUSS/MIC
RC101A:TENS/EMS/RUSS/IF
R-C101B:TENS/EMS/RUSS/IF
R-C101E:RUSS/IF
R-C101H:TENS/IF
R-C101D:TENS
R-C101G:TENS/EMS | Different
Note 1
The number of treatment programs only
different by design; the core principles of
these two devices are similar but does not
adversely impact safety and effectiveness of
subject device. |
| 7 | Number of
Output
Channels | 2 | 2 | Same |
| UN | - Synchronousor
Alternating? | Synchronous andAlternating | Synchronous andAlternating | Same |
| | - Method of
Channel
Isolation? | By enclosure | By enclosure | Same |
| 8 | Constant
Current?
Constant
Voltage? | Yes
No | Yes
No | Same |
| 9 | Software/Firmware/
Microproce
ssor Control? | Yes | Yes | Same |
| 10 | Automatic
Overload Trip?
Automatic Over
Current
Trip? | Yes | Yes | Same |
| 11 | Automatic NoLoad
Trip? | Yes | Yes | Same |
| 12 | AutomaticShut
off? | Yes | Yes | Same |
| 13 | Patient
Override
Control? | No | No | Same |
| 14 | Indicator Display | | | |
| No. | Item | Predicate device (K171978) | New device (K231440) | Discussion |
| | -On/Off
Status? | Yes | Yes | Same |
| | -Voltage/Current
Level? | Yes | Yes | Same |
| | -Low Battery? | Yes | Yes | Same |
| 15 | Waveform
TENS EMS
Interferential
Microcurrent
Russian | Biphasic Biphasic
Biphasic Monophasic
Biphasic | MIC : Mono-phaseOther : Bi-phase | Same |
| 16 | Shape
TENS
EMS
Interferential
Microcurrent
Russian | Square
Square
SquareSquare
Square | Square
Square
Square
Square
Square | Same |
| 17 | Max Output Voltage (V) ±20% | | | |
| | 500Ω
TENS
EMS
Interferential
Microcurrent
Russian | 50
50
15.75
0.4
15.75 | 45
45
15
0.35
45 | Different
Note 2
Based on the calculation refer Note 3 of
maximum current density, maximum
average power density , these parameters
don't exceed the safety limit. and these
parameters have passed IEC 60601-2-10
test codes. So these differences will not
raise any new safety and effectiveness
issues. |
| | 2kΩ
TENS
EMS
Interferential
Microcurrent
Russian | 102
102
33
1.6
33 | 96
96
30
1.48
94 | |
| | 10kΩ
TENS
EMS
Interferential
Microcurrent
Russian | Not publicly available | 96
96
30
1.48
94 | |
| 18 | Max Output Current (mA) ±20% | | | |
| No. | Item | Predicate device (K171978) | New device (K231440) | Discussion |
| | 500Ω
TENS
EMS
Interferential
Microcurrent
Russian | 100
100
31.5
0.8
31.5 | 90
90
30
0.7
90 | Different
Note 2
Based on the calculation refer Note 3 of
maximum current density, maximum
average power density , these parameters
don't exceed the safety limit. and these
parameters have passed IEC 60601-2-10
test codes. So these differences will not
raise any new safety and effectiveness
issues. |
| | 2kΩ
TENS
EMS
Interferential
Microcurrent
Russian | 51
51
16.5
0.8
16.5 | 48
48
15
0.74
47 | |
| | 10kΩ
TENS
EMS
Interferential
Microcurrent
Russian | Not publicly available | 9.6
9.6
3
0.148
9.4 | |
| 19 | Pulse Width
Range TENS
EMS
Interferential
MicrocurrentRussian | TENS:50-400uS
EMS:200400uS150Hz EMS:1~100Hz
IF:100/200/400uS MIC:2-200ms
RUSS:400uS | TENS/EMS: 50 to 450 μs ;
IF:50µs/100µs ; MIC: 2ms -
500msRUSS: 200μs | |
| 20 | Frequency
TENS EMS
Interferential
MicrocurrentRussian | TENS:1
IF:2.5K,5K,10K HzMIC:1-150Hz
RUSS:2.5kHz | 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 | |
| 21 | Beat
Frequency
Interferential | 1-200Hz | 1-200Hz | Same |
| 22 | 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
Note 3
have passed IEC 60601-2-10 test. the
Maximum Current Density of the subject
device is lower than 2 mA/cm² refers to
"IEC60601-2-10 Clause 201.4.2" and the
Maximum Average Power Density is less
than 0.25 W/cm² refer to "Guidance
Document for Powered Muscle Stimulator
510(k)s |
| | 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 | |
| No. | Item | Predicate device (K171978) | New device (K231440) | Discussion |
| | Net Charge (µC)
per pulse | Not publicly available | TENS: 0 µC @500Ω Method: Balanced waveform
EMS: 0 µC @500Ω Method: Balanced waveform
IF: 0 µC @500Ω Method: Balanced waveform
MIC: 0 µC @500Ω Method: Balanced waveform
RUSS: 0 µC @500Ω Method: Balanced waveform | |
| | Max.Average current
(average absolute
value, 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 | |
| | 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 | |
| | ON Time | Not publicly available | TENS: N/A
EMS: 1-90 S
IF: N/A
MIC: N/A
RUSS:1-90 S | Although the "on/off" time is slightly
different for both devices it is compliant
with FDA Guidance Document
for Powered Muscle Stimulator 510(k)s
and the difference between on and off time |
| | OFF time | Not publicly available | TENS: N/A
EMS: 1-90 S
IF: N/A
MIC: N/A
RUSS: 1-90 S | ranges doesn't impact
essential performance, basic safety or
substantial equivalence. |
| 23 | Electrode area (cm2) | 25 | 25 | Same |
| 24 | Timer Range
(minutes) | 5-90 minutes | 5-90 minutes | Same |
| 25 | Compliancewith
Voluntary
Standards? | IEC60601-1, IEC60601-1-2,
IEC60601-2-10 | IEC60601-1, IEC60601-1-2,
IEC60601-2-10 | Same |
| 26 | Compliancewith
21
CFR 898? | Yes | Yes | Same |
| 27 | Weight (lbs.) | 0.28 | About 140 grams(0.31lbs) | Different,
Note 4 |
| 28 | Dimensions H x
WxL | 4.6x2.36x0.9 inch | 120.5 mm (L) x 69.5 mm (W) x 27mm (H) | Differences in physical and electronic
component characteristics do not raise
different questions of safety &
effectiveness. |
| No. | Item | Predicate device (K171978) | New device (K231440) | Discussion |
| 29 | Housing
Materials &
Construction | Enclosure: ABS | Enclosure: ABS | Same |
| 30 | Burst Mode (i.e., pulse trains) | | | |
| | a. Pulses per burst | Not publicly available | TENS: 7
EMS: N/A
IF: N/A
MIC: N/A
RUSS: N/A | Different but does not adversely impact
safety and effectiveness of subject device |
| | b. Bursts per second | Not publicly available | TENS: 0.5, 1, 2, 3, 4, 5
EMS: N/A
IF: N/A
MIC: N/A
RUSS: N/A | |
| | c. Burst duration
(seconds) | Not publicly available | TENS: 70mS
EMS: N/A
IF: N/A
MIC: N/A
RUSS: N/A | |
| | d. Duty Cycle [Line (b)
x Line (c)] | Not publicly available | TENS: 3.5% - 35%
EMS: N/A
IF: N/A
MIC: N/A
RUSS: N/A | |
| 31 | Description of Accessories | | | |
| | 1. Electrodes | self-adhesive electrode (50mm x 50mm) | self-adhesive electrode (50mm x 50mm) | Same |
| | 2. Electrode Conductive
Medium (Gel) | self-adhesive electrode with conductive media (gel) | self-adhesive electrode with conductive media (gel) | Same |
| | 3. Electrode Lead Wires
and 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
-
- 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
-
- 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
-
- 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.