(250 days)
Over-The-Counter Use:
a. Model R-C101C is indicated for OTC TENS and OTC EMS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. OTC EMS(NGX) This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
b. Model R-C101D is indicated for OTC TENS. It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
c. Model R-C101F is indicated for OTC TENS and OTC EMS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. OTC EMS(NGX) This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
d. Model R-C101G is indicated for OTC TENS and OTC EMS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. OTC EMS(NGX) This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
e. Model F100 is indicated for OTC TENS and OTC EMS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. OTC EMS(NGX) This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
f. Model MINI-TENS-COMB is indicated for OTC TENS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
g. Model R-C101I is indicated for OTC TENS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
h. Model TENS3500 is indicated for OTC TENS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
Prescription Use:
a. Model R-C101D is indicated for Rx TENS. Rx TENS(GZJ) 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain;
b. Model R-C101G is indicated for Rx TENS and Rx EMS. Rx TENS(GZJ) 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; Rx EMS(IPF): 1)Relaxation of muscle spasm; 2)Increase of local blood flow circulation: 3)Prevention or retardation of disuse atrophy: 4)Muscle re-education: 5)Maintaining or increasing range of motion; 6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
c. Model R-C101C, is indicated for Rx TENS and Rx EMS. Rx TENS(GZJ) : 1)Symptomatic rlief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; Rx EMS(IPF): 1)Relaxation of muscle spasm; 2)Increase of local blood flow circulation: 3)Prevention or retardation of disuse atrophy: 4)Muscle re-education: 5)Maintaining or increasing range of motion; 6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
d. Model F100 is indicated for Rx TENS and Rx EMS. Rx TENS(GZJ) : 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; Rx EMS(IPF): 1)Relaxation of muscle spasm; 2)Increase of local blood flow circulation: 3)Prevention or retardation of disuse atrophy: 4)Muscle re-education: 5)Maintaining or increasing range of motion; 6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
e. Model MINI-TENS-COMB is indicated for Rx TENS. 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain;
f. Model R-C101F is indicated for Rx TENS and Rx EMS. Rx TENS(GZJ) : 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; Rx EMS(IPF): 1)Relaxation of muscle spasm; 2)Increase of local blood flow circulation: 3)Prevention or retardation of disuse atrophy: 4)Muscle re-education: 5)Maintaining or increasing range of motion; 6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
g. Model R-C101I is indicated for Rx TENS. Rx TENS(GZJ) : 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain;
h. Model TENS3500 is indicated for Rx TENS. Rx TENS(GZJ) : 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain;
Combo Electrotherapy Device (Model:R-C101C,R-C101F,R-C101G,F100,MINI-TENS-COMB,R-C1011, TENS3500) are Transcutaneous Electrical Nerve Stimulator and muscle stimulator The Device feature two independent output channels and four self-adhesive electrode gel pads. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrode applied on the skin. They offer a wide range of functions for increasing general well- being, pain relief, maintaining physical fitness, relaxation.For these purpose, the user can either choose from pre-set programs or specify their own to suit the user's individual needs. Software controls all controls and indicators. Software controls waveform characteristics. The 8 models have Similar housing with a viewable LCD display,an accessible keypad.The LCD is located on the upper half of the rectangular face of the device, above the keypad. The LCD is used to display system information to the user. The device is battery powered and can be connected to an external power supply for charging the internal battery. The battery is 3.7V D.C.,Li-ion batteries and is not user serviceable or accessible. The only external connections on the device are the power input and the electrode connector there is no connection to any other device. The Battery Charger is not provided in the package, but users will choose adapters that meet the IEC 60601-1 medical standard.
The provided document is a 510(k) Premarket Notification from the FDA, evaluating the substantial equivalence of the "Combo Electrotherapy Device" to existing predicate devices. It focuses on technical specifications and safety standards rather than clinical performance or acceptance criteria in the typical sense of a clinical trial. Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set sample size) are not applicable or detailed in this type of regulatory submission.
However, I can extract information related to acceptance criteria as demonstrated by compliance with recognized standards and a comparison to the predicate devices' performance.
The primary acceptance criteria for this device are demonstrated through compliance with recognized electrical safety and performance standards, as well as showing substantial equivalence to existing predicate devices in terms of intended use and technological characteristics.
Here's a breakdown of the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission, "acceptance criteria" are generally met by demonstrating compliance with applicable safety standards and showing that any differences from predicate devices do not raise new safety or effectiveness concerns. The "reported device performance" is primarily presented as a comparison to the predicate devices' specifications, along with statements of compliance to relevant IEC standards.
| Acceptance Criterion (via Standard/Compliance) | Reported Device Performance (Subject Device K231423) | Comparison to Predicate (K192087 & K181688&180956) | Discussion/Outcome |
|---|---|---|---|
| Patient Leakage Current | Normal Condition: Patient Leakage Current (P): 5 uA; Patient Leakage Current with mains on the F-type applied parts (PM): 9 uA Single Fault Condition: Patient Leakage Current (P): 172 uA; Patient Leakage Current with mains on the F-type applied parts (PM): 132 uA | Normal Condition: Primary Predicate (K192087): 50uA (R-C3, R-C4A, R-C4C); 53uA (R-C4B, R-C4D) Reference Predicate (K181688&180956): 11.4 uA Single Fault Condition: Primary Predicate (K192087): 31uA (R-C3, R-C4A, R-C4C); 58uA (R-C4B, R-C4D) Reference Predicate (K181688&180956): 9.6uA | Different. However, stated to meet IEC 60601-1 requirements (less than 500 uA for Type BF applied parts under Single Fault Condition), demonstrating no new safety or effectiveness risks. |
| Maximum Output Voltage (Vpp) | @500Ω: 46.4 @2KΩ: 94 @10KΩ: 94 | Primary Predicate (K192087): @500Ω: 66.4; @2KΩ: 106; @10KΩ: 106 Reference Predicate (K181688&180956): @500Ω: 30; @2KΩ: 108; @10KΩ: 108 | Different. However, stated that calculations for maximum current density and average power density meet safety limits and passed IEC 60601-2-10 tests. |
| Maximum Output Current (mA) | @500Ω: 92.8 @2KΩ: 47 @10KΩ: 9.4 | Primary Predicate (K192087): @500Ω: 132.8; @2KΩ: 53; @10KΩ: 10.6 Reference Predicate (K181688&180956): @500Ω: 60; @2KΩ: 54; @10KΩ: 10.8 | Different. See discussion for Max Output Voltage. |
| Pulse Width Range (uS) | 50-450uS | Primary Predicate (K192087): 150~300uS (R-C3, R-C4C, R-C4D); 55-300uS (R-C4A, R-C4B) Reference Predicate (K181688&180956): 100-380uS | Different. Stated that it does not adversely impact safety and effectiveness. |
| Frequency (Hz) | 2-150 Hz | Primary Predicate (K192087): 2 | Different. Minor differences do not raise safety or effectiveness issues as per IEC 60601-2-10. |
| Maximum Phase Charge (uC, 500Ω) | 2.73 (TENS mode); 2.73 (EMS mode) | Primary Predicate (K192087) TENS: 0.15 (R-C3, R-C4C, R-C4D, R-C4A); 0.14 (R-C4B) Primary Predicate (K192087) EMS: 0.13 (R-C3, R-C4C, R-C4D); 0.15 (R-C4A, R-C4B) Reference Predicate (K181688&180956): 22.8 (both TENS/EMS) | Different. However, Maximum Current Density for the subject device is lower than 2 mA/cm² (referencing IEC 60601-2-10 Clause 201.14.2) and the Maximum Average Power Density for Powered Muscle Simulator (0.25 Watts/cm²), concluding no new safety/effectiveness risks. |
| Max Current Density (mA/cm², 500Ω, r.m.s) | 0.24 | Primary Predicate (K192087): 0.15 Reference Predicate (K181688&180956): 2.4 | Different. See discussion for Maximum Phase Charge. |
| Max. Average Current (mA) | 6.075 (TENS mode); 6.075 (EMS mode) | Primary Predicate (K192087) TENS: 3.74 (R-C3, R-C4C, R-C4D, R-C4A); 3.46 (R-C4B) Primary Predicate (K192087) EMS: 3.36 (R-C3, R-C4C, R-C4D); 3.84 (R-C4A, R-C4B) Reference Predicate (K181688&180956): 16.8 (both TENS/EMS) | Different. See discussion for Maximum Phase Charge. |
| Maximum Power Density (W/cm², 500Ω, r.m.s) | 0.74 mW/cm² (TENS mode); 0.74 mW/cm² (EMS mode) | Primary Predicate (K192087) TENS: 0.28 mW/cm² (R-C3, R-C4C, R-C4D, R-C4A); 0.24 mW/cm² (R-C4B) Primary Predicate (K192087) EMS: 0.23 mW/cm² (R-C3, R-C4C, R-C4D); 0.29 mW/cm² (R-C4A, R-C4B) Reference Predicate (K181688&180956): 0.072 | Different. The stated calculation indicates that the maximum average power density for the subject device is 0.74 mW/cm^2, which is less than the regulatory limit of 0.25 Watts/cm² (250 mW/cm²). |
| Compliance with IEC 60601-1 | Compliant | Compliant | Same |
| Compliance with IEC 60601-2-10 | Compliant | Compliant | Same |
| Compliance with IEC 60601-1-2 (EMC) | Compliant | Compliant | Same |
| Compliance with IEC 60601-1-11 | Compliant | Compliant | Same |
| Biocompatibility | Compliant with ISO 10993 (for self-adhesive electrodes) | Same accessories as previously submitted (K222252) | Same accessories, previously evaluated. |
| Software Verification & Validation | Documentation provided; "Moderate" level of concern. | N/A (software details not provided for predicates, but generally accepted similar for Class II devices) | Complies with FDA guidance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not applicable. For a 510(k) submission based on technical equivalence, bench testing and compliance with standards are typically performed on representative units of the device itself, not a 'test set' of patient data in the clinical sense.
- Data provenance: The tests performed are "Non-Clinical Data" and "Bench Testing," conducted to verify device specifications and compliance with standards. These are typically laboratory tests of the device. The manufacturing company is Shenzhen Roundwhale Technology Co., Ltd. in Longgang District, Shenzhen, China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is a technical and safety review of an electrotherapy device, not an image-based diagnostic or screening AI device requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As above, this type of adjudication is for clinical or diagnostic studies, not for the technical bench testing described.
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 an electrotherapy device, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. The device is a physical electrotherapy device; its performance is independently verifiable through electrical measurements and safety standards compliance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this submission are the recognized international and national standards (e.g., IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 60601-1-11, ISO 10993) and the specifications and performance of the legally marketed predicate devices. The testing confirmed that the subject device's performance aligned with these standards and was substantially equivalent to the predicate.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set of data.
9. How the ground truth for the training set was established
- Not applicable. (See answer to point 8).
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 22, 2024
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: K231423
Trade/Device Name: Combo Electrotherapy Device (Models: R-C101C, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500) Regulation Number: 21 CFR 882.5890: 21 CFR 890.5850 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, GZJ, IPF, NGX Dated: September 5, 2023 Received: September 5, 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.
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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" (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 QS 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).
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Sincerely,
Robert Kang -S
for Pamela Scott, MS Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231423
Device Name Combo Electrotherapy Device
Indications for Use (Describe) Over-The-Counter Use: a. Model R-C101C is indicated for OTC TENS and OTC EMS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. OTC EMS(NGX) This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. b. Model R-C101D is indicated for OTC TENS. It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. c. Model R-C101F is indicated for OTC TENS and OTC EMS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. OTC EMS(NGX) This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. d. Model R-C101G is indicated for OTC TENS and OTC EMS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. OTC EMS(NGX) This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. e. Model F100 is indicated for OTC TENS and OTC EMS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. OTC EMS(NGX) This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. f. Model MINI-TENS-COMB is indicated for OTC TENS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. g. Model R-C101I is indicated for OTC TENS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
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h. Model TENS3500 is indicated for OTC TENS. OTC TENS(NUH)
It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
Prescription Use: a. Model R-C101D is indicated for Rx TENS. Rx TENS(GZJ) 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain;
b. Model R-C101G is indicated for Rx TENS and Rx EMS. Rx TENS(GZJ) 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; Rx EMS(IPF): 1)Relaxation of muscle spasm; 2)Increase of local blood flow circulation: 3)Prevention or retardation of disuse atrophy: 4)Muscle re-education: 5)Maintaining or increasing range of motion; 6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. c. Model R-C101C, is indicated for Rx TENS and Rx EMS. Rx TENS(GZJ) :
1)Symptomatic rlief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; Rx EMS(IPF): 1)Relaxation of muscle spasm; 2)Increase of local blood flow circulation: 3)Prevention or retardation of disuse atrophy: 4)Muscle re-education: 5)Maintaining or increasing range of motion; 6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. d. Model F100 is indicated for Rx TENS and Rx EMS.
Rx TENS(GZJ) : 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; Rx EMS(IPF): 1)Relaxation of muscle spasm; 2)Increase of local blood flow circulation: 3)Prevention or retardation of disuse atrophy: 4)Muscle re-education: 5)Maintaining or increasing range of motion; 6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
e. Model MINI-TENS-COMB is indicated for Rx TENS.
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| 1)Symptomatic relief of chronic intractable pain; |
|---|
| 2)Post traumatic pain; |
| 3)Post surgical pain; |
f. Model R-C101F is indicated for Rx TENS and Rx EMS.
Rx TENS(GZJ) :
| 1)Symptomatic relief of chronic intractable pain; |
|---|
| 2)Post traumatic pain; |
| 3)Post surgical pain; |
Rx EMS(IPF):
| 1)Relaxation of muscle spasm; |
|---|
| 2)Increase of local blood flow circulation: |
| 3)Prevention or retardation of disuse atrophy: |
| 4)Muscle re-education: |
| 5)Maintaining or increasing range of motion; |
| 6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. |
g. Model R-C101I is indicated for Rx TENS.
Rx TENS(GZJ) :
| 1)Symptomatic relief of chronic intractable pain; |
|---|
| 2)Post traumatic pain; |
| 3)Post surgical pain; |
h. Model TENS3500 is indicated for Rx TENS.
Rx TENS(GZJ) :
| 1)Symptomatic relief of chronic intractable pain; |
|---|
| 2)Post traumatic pain; |
| 3)Post surgical pain; |
Type of Use (Select one or both, as applicable)
| ❎ Prescription Use (Part 21 CFR 801 Subpart D) | ❎ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------- |
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510(K) SUMMARY - K231423
This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92.
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: | December 11,2023 |
Application Correspondent:
| 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: | Amos Zou |
| TEL: | +86-15015249549 |
| E-mail: | amos.zou@139.copm |
| Date of Prepared: | December 11,2023 |
2. Proposed Device and code:
| Device | Combo Electrotherapy Device | |||||||
|---|---|---|---|---|---|---|---|---|
| name: | ||||||||
| Model: | R-C101C | R-C101D | R-C101F | R-C101G | F100 | MINI-TENS-COMB | R-C101I, | TENS3500 |
| associa | OTC | OTC | OTC | OTC | OTC | OTC | OTC | OTC |
| ted | TENS, | TENS, | TENS, | TENS, | TENS, | TENS, | TENS, | TENS, |
| claims | OTCEMS | OTCEMS | OTCEMS | OTCEMS | OTCEMS | OTCEMS | OTCEMS | OTCEMS |
| Classificationproduct | NUH | NUH | NUH | NUH | NUH | NUH | NUH | NUH |
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| code: | ||||||||
|---|---|---|---|---|---|---|---|---|
| Subsequentproductcode: | NGX | / | NGX | NGX | NGX | / | / | / |
| Regulationnumber: | 1) 882.58902) 890.5850 |
| Devicename: | Combo Electrotherapy Device | |||||||
|---|---|---|---|---|---|---|---|---|
| Model: | R-C101C | R-C101D | R-C101F | R-C101G | F100 | MINI-TENS-COMB | R-C101I, | TENS3500 |
| associatedclaims | Rx TENS,Rx EMS | Rx TENS, | Rx TENS,Rx EMS | Rx TENS,Rx EMS | Rx TENS,Rx EMS | Rx TENS, | Rx TENS, | Rx TENS |
| Classificationproductcode: | GZJ | GZJ | GZJ | GZJ | GZJ | GZJ | GZJ | GZJ |
| Subsequentproductcode: | IPF | / | IPF | IPF | IPF | / | / | / |
| Regulationnumber: | 1)882.58902)890.5850 |
3. Predicate Device:
Primary predicate device
| 510(K) | Trade or Proprietary or Model Name | Manufacturer | Product Code |
|---|---|---|---|
| K192087 | Combo Electrotherapy Device | Shenzhen Roundwhale Technology Co., Ltd. | NUH,GZJ,IPF,NGX |
Reference Predicate device
| 510(K) | Trade or Proprietary or Model Name | Manufacturer | Product Code |
|---|---|---|---|
| K181688&180956 | TENS and EMS Stimulator R-C1 | Shenzhen Roundwhale Technology Co., Ltd. | IPF, GZJ; NUH, NGX |
{8}------------------------------------------------
4. Description of Proposed Device:
Combo Electrotherapy Device (Model:R-C101C,R-C101F,R-C101G,F100,MINI-TENS-COMB,R-C1011, TENS3500) are Transcutaneous Electrical Nerve Stimulator and muscle stimulator The Device feature two independent output channels and four self-adhesive electrode gel pads. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrode applied on the skin. They offer a wide range of functions for increasing general well- being, pain relief, maintaining physical fitness, relaxation.For these purpose, the user can either choose from pre-set programs or specify their own to suit the user's individual needs. Software controls all controls and indicators. Software controls waveform characteristics.
The 8 models have Similar housing with a viewable LCD display,an accessible keypad.The LCD is located on the upper half of the rectangular face of the device, above the keypad. The LCD is used to display system information to the user. The device is battery powered and can be connected to an external power supply for charging the internal battery. The battery is 3.7V D.C.,Li-ion batteries and is not user serviceable or accessible. The only external connections on the device are the power input and the electrode connector there is no connection to any other device. The Battery Charger is not provided in the package, but users will choose adapters that meet the IEC 60601-1 medical standard.
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:
- self-adhesive electrode (50mm x 50mm) with conductive media (gel) and Electrode Lead Wires that is a Class II previously approved device. (K222252,manufacturer:Shenzhen Roundwhale Technology Co., Ltd.), and can be packaged with 510(k) cleared devices or packaged 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.
- An 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,submission type:510(k) Exempt,device class:2, Regulation Number:890.1175
- 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.
న్. Indications for Use
Over-The-Counter Use:
a. Model R-C101C is indicated for OTC TENS and OTC EMS.
OTC TENS (NUH)
It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
OTC EMS (NGX)
This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
b. Model R-C101D is indicated for OTC TENS.
OTC TENS(NUH)
{9}------------------------------------------------
It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
c. Model R-C101F is indicated for OTC TENS and OTC EMS.
OTC TENS(NUH)
It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
OTC EMS(NGX)
This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
d. Model R-C101G is indicated for OTC TENS and OTC EMS.
OTC TENS(NUH)
It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
OTC EMS(NGX)
This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
e. Model F100 is indicated for OTC TENS and OTC EMS.
OTC TENS(NUH)
It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
OTC EMS(NGX)
This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
f. Model MINI-TENS-COMB is indicated for OTC TENS.
OTC TENS(NUH)
It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
g. Model R-C101I is indicated for OTC TENS.
OTC TENS(NUH)
It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
{10}------------------------------------------------
h. Model TENS3500 is indicated for OTC TENS.
OTC TENS(NUH)
It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
Prescription Use:
a. Model R-C101D is indicated for Rx TENS.
Rx TENS(GZJ).
1)Symptomatic relief of chronic intractable pain;
2)Post traumatic pain;
3)Post surgical pain;
b. Model R-C101G is indicated for Rx TENS and Rx EMS.
Rx TENS(GZJ):
1)Symptomatic relief of chronic intractable pain;
2)Post traumatic pain;
3)Post surgical pain;
Rx EMS(IPF):
1)Relaxation of muscle spasm;
2)Increase of local blood flow circulation:
3)Prevention or retardation of disuse atrophy:
4)Muscle re-education:
5)Maintaining or increasing range of motion;
6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
c. Model R-C101C, is indicated for Rx TENS and Rx EMS.
Rx TENS(GZJ):
1)Symptomatic relief of chronic intractable pain;
2)Post traumatic pain;
3)Post surgical pain;
Rx EMS(IPF):
{11}------------------------------------------------
1)Relaxation of muscle spasm;
- 2)Increase of local blood flow circulation:
- 3)Prevention or retardation of disuse atrophy:
4)Muscle re-education:
- 5)Maintaining or increasing range of motion;
- 6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
d. Model F100 is indicated for Rx TENS and Rx EMS.
Rx TENS(GZJ):
1)Symptomatic relief of chronic intractable pain;
2)Post traumatic pain;
3)Post surgical pain;
Rx EMS(IPF):
1)Relaxation of muscle spasm;
2)Increase of local blood flow circulation:
3)Prevention or retardation of disuse atrophy:
4)Muscle re-education:
5)Maintaining or increasing range of motion;
6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
e. Model MINI-TENS-COMB is indicated for Rx TENS.
Rx TENS(GZJ):
1)Symptomatic relief of chronic intractable pain;
2)Post traumatic pain;
3)Post surgical pain;
f. Model R-C101F is indicated for Rx TENS and Rx EMS.
Rx TENS(GZJ):
1)Symptomatic relief of chronic intractable pain;
2)Post traumatic pain;
3)Post surgical pain;
Rx EMS(IPF):
{12}------------------------------------------------
1)Relaxation of muscle spasm;
- 2)Increase of local blood flow circulation:
- 3)Prevention or retardation of disuse atrophy:
4)Muscle re-education:
- 5)Maintaining or increasing range of motion;
- 6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
g. Model R-C101I is indicated for Rx TENS.
- Rx TENS(GZJ):
1)Symptomatic relief of chronic intractable pain;
2)Post traumatic pain;
3)Post surgical pain;
h. Model TENS3500 is indicated for Rx TENS.
Rx TENS(GZJ):
1)Symptomatic relief of chronic intractable pain;
2)Post traumatic pain;
3)Post surgical pain;
Technical and Performance 6.
The following table compares the device to the predicate device with basic technological characteristics.
{13}------------------------------------------------
| Item | Primary predicate device(K192087) | Reference Predicate device(K181688&180956) | Subject Device(K231423) | Discussion | |
|---|---|---|---|---|---|
| 510(K) | K192087 | K181688&180956 | K231423 | / | |
| Device Name | Combo Electrotherapy Device, model R-C3,R-C4A, R-C4B, R-C4C and R-C4D | TENS and EMS Stimulator R-C1 | Combo Electrotherapy Device,Model:R-C101C,R-C101D,R-C101F,R-C101G, F100,MINI-TENS-COMB,R-C101I, TENS3500) | / | |
| Manufacturer | Shenzhen Roundwhale Technology Co.,Ltd. | Shenzhen Roundwhale Technology Co.,Ltd. | Shenzhen Roundwhale Technology Co.,Ltd. | / | |
| Prescription or OTC | OTC & Prescription | Prescription & OTC | OTC & Prescription | Same | |
| FDA product code | NUH, NGX, IPF, GZJ | IPF, GZJ; NUH, NGX | NUH, NGX, IPF, GZJ | Same | |
| Intended Use | Over-The-Counter Use: | Over-the-Counter Use: | Over-The-Counter Use: | Same | |
| TENS mode: | For TENS: | a. Model R-C101C is indicated for OTCTENS and OTC EMS. | |||
| It is used for temporary relief of painassociated with sore and aching musclesin the neck, shoulder, back, upperextremities (arm) and lower extremities(leg) due to strain from exercise ornormal household work activities.EMS mode:This mode is designed to be used forstimulate healthy muscles in order toimprove and facilitate muscleperformancePrescription Use:For TENS mode:1)Symptomatic relief of chronic | This mode is designed to be used fortemporary relief of pain associated withsore and aching muscles in the shoulder,waist, back, neck, upper extremities (arm),and lower extremities (leg) due to strainfrom exercise or normal household workactivities.For EMS:This mode is designed to be used forstimulate healthy muscles in order toimprove and facilitate muscle performance.Prescription Use:For TENS mode:1)Symptomatic relief of chronic intractable | OTC TENS(NUH)It is used for temporary relief of painassociated with sore and aching musclesin the neck, shoulder, back, upperextremities (arm) and lower extremities(leg) due to strain from exercise ornormal household work activities.OTC EMS(NGX)This mode is designed to be used forstimulate healthy muscles in order toimprove and facilitate muscleperformance. | |||
| intractable pain;2)Post traumatic pain; | pain;2)Post traumatic pain; | b. Model R-C101D is indicated for OTCTENS. | |||
| Item | Primary predicate device(K192087) | Reference Predicate device(K181688&180956) | Subject Device(K231423) | Discussion | |
| 3)Post surgical pain; | 3)Post surgical pain; | OTC TENS(NUH) | |||
| For EMS mode: | For EMS mode: | It is used for temporary relief of painassociated with sore and aching musclesin the neck, shoulder, back, upperextremities (arm) and lower extremities(leg) due to strain from exercise ornormal household work activities. | |||
| 1)Relaxation of muscle spasm; | 1)Relaxation of muscle spasm; | ||||
| 2)Increase of local blood flowcirculation: | 2)Increase of local blood flow circulation; | ||||
| 3)Prevention or retardation of disuseatrophy: | 3)Prevention or retardation of disuseatrophy; | ||||
| 4)Muscle re-education: | 4)Muscle re-education; | c. Model R-C101F is indicated for OTCTENS and OTC EMS. | |||
| 5)Maintaining or increasing range ofmotion; | 5)Maintaining or increasing range ofmotion; | OTC TENS(NUH) | |||
| 6) Immediate post-surgical stimulation ofcalf muscles to prevent venousthrombosis. | 6)Immediate post-surgical stimulation ofcalf muscles to prevent venous thrombosis. | It is used for temporary relief of painassociated with sore and aching musclesin the neck, shoulder, back, upperextremities (arm) and lower extremities(leg) due to strain from exercise ornormal household work activities. | |||
| OTC EMS(NGX) | |||||
| This mode is designed to be used forstimulate healthy muscles in order toimprove and facilitate muscleperformance. | |||||
| d. Model R-C101G is indicated for OTCTENS and OTC EMS. | |||||
| OTC TENS(NUH) | |||||
| It is used for temporary relief of painassociated with sore and aching musclesin the neck, shoulder, back, upperextremities (arm) and lower extremities(leg) due to strain from exercise ornormal household work activities. | |||||
| Item | Primary predicate device(K192087) | Reference Predicate device(K181688&180956) | Subject Device(K231423) | Discussion | |
| OTC EMS(NGX) | |||||
| This mode is designed to be used forstimulate healthy muscles in order toimprove and facilitate muscleperformance. | |||||
| e. Model F100 is indicated for OTCTENS and OTC EMS. | |||||
| OTC TENS(NUH) | |||||
| It is used for temporary relief of painassociated with sore and aching musclesin the neck, shoulder, back, upperextremities (arm) and lower extremities(leg) due to strain from exercise ornormal household work activities. | |||||
| OTC EMS(NGX) | |||||
| This mode is designed to be used forstimulate healthy muscles in order toimprove and facilitate muscleperformance. | |||||
| f. Model MINI-TENS-COMB isindicated for OTC TENS. | |||||
| OTC TENS(NUH) | |||||
| It is used for temporary relief of painassociated with sore and aching musclesin the neck, shoulder, back, upperextremities (arm) and lower extremities(leg) due to strain from exercise ornormal household work activities. | |||||
| g. Model R-C101I is indicated for OTCTENS. | |||||
| OTC TENS(NUH) | |||||
| Item | Primary predicate device(K192087) | Reference Predicate device(K181688&180956) | Subject Device(K231423) | Discussion | |
| It is used for temporary relief of painassociated with sore and aching musclesin the neck, shoulder, back, upperextremities (arm) and lower extremities(leg) due to strain from exercise ornormal household work activities. | |||||
| h. Model TENS3500 is indicated forOTC TENS. | |||||
| OTC TENS(NUH) | |||||
| It is used for temporary relief of painassociated with sore and aching musclesin the neck, shoulder, back, upperextremities (arm) and lower extremities(leg) due to strain from exercise ornormal household work activities. | |||||
| Prescription Use: | |||||
| a. Model R-C101D is indicated for RxTENS. | |||||
| Rx TENS(GZJ). | |||||
| 1)Symptomatic relief of chronicintractable pain; | |||||
| 2)Post traumatic pain; | |||||
| 3)Post surgical pain; | |||||
| b. Model R-C101G is indicated for RxTENS and Rx EMS. | |||||
| Rx TENS(GZJ): | |||||
| 1) Symptomatic relief of chronic | |||||
| Item | Primary predicate device(K192087) | Reference Predicate device(K181688&180956) | Subject Device(K231423) | Discussion | |
| intractable pain; | |||||
| 2)Post traumatic pain; | |||||
| 3)Post surgical pain; | |||||
| Rx EMS(IPF): | |||||
| 1)Relaxation of muscle spasm; | |||||
| 2)Increase of local blood flowcirculation: | |||||
| 3)Prevention or retardation of disuseatrophy: | |||||
| 4)Muscle re-education: | |||||
| 5)Maintaining or increasing range ofmotion; | |||||
| 6)Immediate post-surgical stimulationof calf muscles to prevent venousthrombosis. | |||||
| c. Model R-C101C, is indicated for RxTENS and Rx EMS. | |||||
| Rx TENS(GZJ): | |||||
| 1)Symptomatic relief of chronicintractable pain; | |||||
| 2)Post traumatic pain; | |||||
| 3)Post surgical pain; | |||||
| Rx EMS(IPF): | |||||
| 1)Relaxation of muscle spasm; | |||||
| 2)Increase of local blood flowcirculation: | |||||
| Item | Primary predicate device(K192087) | Reference Predicate device(K181688&180956) | Subject Device(K231423) | Discussion | |
| circulation: | |||||
| 3)Prevention or retardation of disuseatrophy: | |||||
| 4)Muscle re-education: | |||||
| 5)Maintaining or increasing range ofmotion; | |||||
| 6)Immediate post-surgical stimulationof calf muscles to prevent venousthrombosis. | |||||
| d. Model F100 is indicated for RxTENS and Rx EMS. | |||||
| Rx TENS(GZJ): | |||||
| 1)Symptomatic relief of chronicintractable pain; | |||||
| 2)Post traumatic pain; | |||||
| 3)Post surgical pain; | |||||
| Rx EMS(IPF): | |||||
| 1)Relaxation of muscle spasm; | |||||
| 2)Increase of local blood flowcirculation: | |||||
| 3)Prevention or retardation of disuseatrophy: | |||||
| 4)Muscle re-education: | |||||
| 5)Maintaining or increasing range ofmotion; | |||||
| 6)Immediate post-surgical stimulationof calf muscles to prevent venous | |||||
| Item | Primary predicate device(K192087) | Reference Predicate device(K181688&180956) | Subject Device(K231423) | Discussion | |
| thrombosis. | |||||
| e. Model MINI-TENS-COMB isindicated for Rx TENS. | |||||
| Rx TENS(GZJ): | |||||
| 1)Symptomatic relief of chronicintractable pain; | |||||
| 2)Post traumatic pain; | |||||
| 3)Post surgical pain; | |||||
| f. Model R-C101F is indicated for RxTENS and Rx EMS. | |||||
| Rx TENS(GZJ): | |||||
| 1)Symptomatic relief of chronicintractable pain; | |||||
| 2)Post traumatic pain; | |||||
| 3)Post surgical pain; | |||||
| Rx EMS(IPF): | |||||
| 1)Relaxation of muscle spasm; | |||||
| 2)Increase of local blood flowcirculation: | |||||
| 3)Prevention or retardation of disuseatrophy: | |||||
| 4)Muscle re-education: | |||||
| 5)Maintaining or increasing range ofmotion; | |||||
| Item | Primary predicate device(K192087) | Reference Predicate device(K181688&180956) | Subject Device(K231423) | Discussion | |
| 6)Immediate post-surgical stimulationof calf muscles to prevent venousthrombosis. | |||||
| g. Model R-C101I is indicated for RxTENS.Rx TENS(GZJ): | |||||
| 1)Symptomatic relief of chronicintractable pain; | |||||
| 2)Post traumatic pain; | |||||
| 3)Post surgical pain; | |||||
| h. Model TENS3500 is indicated for RxTENS. | |||||
| Rx TENS(GZJ): | |||||
| 1)Symptomatic relief of chronicintractable pain; | |||||
| 2)Post traumatic pain; | |||||
| 3)Post surgical pain; | |||||
| Power source | R-C3, R-C4A and R-C4C:DC 3.7 V/600mAh Li-ion batteryR-C4B and R-C4D: DC 4.5V, 3 ×AAAbatteries | Battery powered, d.c. 6.0V, 4 X AAAbatteries | R-C101D,R-C101G,R-C101C,F100,MINI-TENS-COMB:3.7VD.C.,Li-ion batteriesR-C101F,R-C101I,TENS3500:9Vbatteries | Similar, but the subjectdevice is in compliance withrequirements of IEC 60601-1 | |
| User Interface | By LCD display | By LCD display | By LCD display | Same | |
| Output Channel | Two channels | Two channels | Two channels | Same | |
| Item | Primary predicate device(K192087) | Reference Predicate device(K181688&180956) | Subject Device(K231423) | Discussion | |
| Number of treatmentprograms | R-C3, R-C4C and R-C4D: 9 TENS, 8EMS;R-C4A: 30 TENS, 27 EMS;R-C4B: 10 TENS, 9 EMS | For TENS: 12For EMS: 9 | R-C101D: TENS:30R-C101G: TENS:30,EMS:20R-C101C: TENS:30,EMS:20F100:TENS:1,EMS:1R-C101F: TENS:5,EMS:2MINI-TENS-COMB: TENS:1 OREMS: 1R-C101I: TENS:12TENS3500: TENS:3 | The number of treatmentprograms only different bydesign; the core principlesof these two devices aresimilar but does notadversely impact safety andeffectiveness of subjectdevice | |
| Synchronous orAlternating? | Synchronous and alternating | Synchronous and alternating | alternating | Same | |
| Method of channelisolation | By electrical circuit and software | By electrical circuit and software | software | Same | |
| Constant Current orConstan Voltage? | Constant voltage | Constant voltage | Constant voltage | Same | |
| Waveform | Biphasic square | Biphasic square | Biphasic square | Same | |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Yes | Same | |
| Automatic overload trip? | Yes | Yes | Yes | Same | |
| Automatic Over CurrentTrip? | Yes | Yes | Yes | Same | |
| Automatic No LoadTrip? | Yes | Yes | Yes | Same | |
| Automatic shut off? | Yes | Yes | Yes | Same | |
| Item | Primary predicate device(K192087) | Reference Predicate device(K181688&180956) | Subject Device(K231423) | Discussion | |
| Patient OverrideControl? | Yes | Yes | Yes | Same | |
| Indicatordisplay | On/offstatus | Yes | Yes | Same | Same |
| Low battery | Yes | Yes | Same | Same | |
| Intensitylevel | Yes | Yes | Same | Same | |
| Time range(min) | For R-C3, R-C4C and R-C4D:30min,non-adjustable;For R-C4A and R-C4B:5-90min,adjustable | Nonadjustable 28 minutes | For R-C101C,R-C101D,R-C101G andF100: 5-90 min, adjustable;for MINI-TENS COMB: 20min ;for R-C101I, R C101F, TENS3500 1-60 min and continue ,adjustable) | Similar,Although the "Timer Range"of the subject device arelittle different from thepredicate device, the timerange of the subject deviceis included in the time rangeof the predicate device, So,the difference will not raiseany safety or effectivenessissue. | |
| PatientLeakageCurrent | Normalcondition(uA)Singlefaultcondition(uA) | R-C3, R-C4A and R-C4C:50uAR-C4B and R-C4D:53uAR-C3, R-C4A and R-C4C: 31uAR-C4B and R-C4D: 58uA | 11.4 uA9.6uA | Patient Leakage Current (P): 5 uAPatient Leakage Current with mains onthe F-type applied parts (PM) : 9 uAPatient Leakage Current (P): 172 uAPatient Leakage Current with mains onthe F-type applied parts (PM) : 132 uA | DifferentNote 1 |
| Average DC currentthrough electrodes whendevice is on but nopulses are being applied(uA) | TENS: 0EMS: 0No output no pulse applied | TENS: 0EMS: 0No output no pulse applied | TENS: 0EMS: 0No output no pulse applied | Same | |
| Item | Primary predicate device(K192087) | Reference Predicate device(K181688&180956)pulse applied | Subject Device(K231423) | Discussion | |
| Housing materialsconstruction | Plastic (ABS) enclosure | Plastic (ABS) enclosure | Plastic (ABS) enclosure | Same | |
| Treatment area | For TENS: Any area (Except thosetreatment areas which cannot be appliedas described in the user manual), such asneck, shoulder, back, joint, hip, hand,abdomen, upper extremities (arm) andlower extremities (leg);For EMS: Any area (except thosetreatment areas which cannot be appliedas described in the user manual ) | Any area (Except those treatment areawhich been described in the user manualcan not use), such as Hand, Arm, Chest,Waist, Buttock, Thigh, Calf, Back and lowback etc. | For TENS: Any area(Except thosetreatment areas which cannot be appliedas described in the user manual), suchas neck, shoulder, back, joint, hip, hand,abdomen, upper extremities (arm) andlower extremities (leg);For EMS: Any area (except thosetreatment areas which cannot be appliedas described in the user manual ) | Same | |
| List of applied partmaterial(s) | Electrode - silica gel | Electrode - silica gel | Electrode - silica gel | Same | |
| Compliance with 21CFR 898 ? | Yes | Yes | Yes | Same | |
| Classification | Internally powered equipment | Internally powered equipment | Internally powered equipment | Same | |
| Degree ofprotectionagainstElectricshock | Type BF applied part | Type BF applied part | Type BF applied part | Same | |
| Device Class | Class II | Class II | Class II | Same | |
| Item | Primary predicate device(K192087) | Reference Predicate device(K181688&180956) | Subject Device(K231423) | Discussion | |
| Compliance withVoluntaryStandards? | MechanicalSafety | Compliant with requirements of IEC60601-1, IEC 60601-2-10 safetystandards | Compliant with requirements of IEC60601-1, IEC 60601-2-10 safety standards | Compliant with requirements of IEC60601-1, IEC 60601-2-10 safetystandards | Same |
| ElectricalSafety | Compliant with requirements of IEC60601-1, IEC 60601-2-10, IEC 60601-1-2 safety standards | Compliant with requirements of IEC60601-1, IEC 60601-2-10, IEC 60601-1-2safety standards | Compliant with requirements of IEC60601-1, IEC 60601-2-10, IEC 60601-1-2 safety standards | Same | |
| Energydelivered | The delivered energy is limited accordingto requirements of collateral IEC 60601-2-10 safety standards | The delivered energy is limited accordingto requirements of collateral IEC 60601-2-10 safety standards | The delivered energy is limitedaccording to requirements of collateralIEC 60601-2-10 safety standards | Same | |
| Other | Compliant with requirements of IEC60601-11 safety standard | Compliant with requirements of IEC60601-11 safety standard | Compliant with requirements of IEC60601-11 safety standard | Same | |
| Applied part | Electrode pad | Electrode pad | Electrode pad | Same | |
| Operating temperatureand humidity | 5°C | 5°C | 5°C | Same | |
| Storage temperature andhumidity | -10°C | -10°C | -10°C | Same | |
| Waveform | TENS mode | Biphasic | Biphasic | Biphasic | Same |
| EMS mode | Biphasic | Biphasic | Biphasic | Same | |
| TENS mode | Square | Square | Square | Same | |
| Shape | EMS mode | Square | Square | Square | Same |
| Maximum outputvoltage(Vpp) | @500Ω | 66.4 | 30 | 46.4 | Different |
| @2KΩ | 106 | 108 | 94 | Note 2 | |
| @10KΩ | 106 | 108 | 94 | ||
| MaxOutput | @500Ω | 132.8 | 60 | 92.8 | |
| Item | Primary predicate device(K192087) | Reference Predicate device(K181688&180956) | Subject Device(K231423) | Discussion | |
| Current(mA) | @2KΩ | 53 | 54 | 47 | |
| @10KΩ | 10.6 | 10.8 | 9.4 | ||
| Pulse Width Range(uS) | R-C3, R-C4C and R-C4D:150~300UsR-C4A and R-C4B: 55-300uS | 100-380uS | 50-450uS | ||
| Frequency (Hz) | R-C3, R-C4C and R-C4D: 2 | 1-125Hz | 2-150 Hz | ||
| Formulti-programwaveforms only | Symmetricalphases? | Yes | YES | Yes | Same |
| PhaseDuration | R-C3, R-C4C and R-C4D:150~300UsR-C4A and R-C4B: 55-300uS | 100-380uS | 50-450uS | Different but does notadversely impact safety Andeffectiveness of subjectdevice | |
| Net Charge per pulsecycle (uC, 500Ω) | 0 | 0 | 0 | Same | |
| Maximum Phase Charge(uC, 500Ω) | TENS mode:R-C3, R-C4C and R-C4D:0.15R-C4A: 0.15R-C4B: 0.14EMS Model:R-C3, R-C4C and R-C4D:0.13R-C4A and R-C4B: 0.15 | 22.822.8 | 2.732.73 | DifferentNote 3 | |
| Maximum CurrentDensity (mA/cm2, 500Ω,r.m.s) | 0.15 | 2.4 | 0.24 | ||
| Item | Primary predicate device(K192087) | Reference Predicate device(K181688&180956) | Subject Device(K231423) | Discussion | |
| Max. Average current(average absolute value,mA) | TENS mode:R-C3, R-C4C and R-C4D:3.74 | 16.8 | 6.075 | ||
| R-C4A: 3.74 | |||||
| R-C4B: 3.46 | |||||
| EMS mode: | 16.8 | 6.075 | |||
| R-C3, R-C4C and R-C4D:3.36 | |||||
| R-C4A and R-C4B: 3.84 | |||||
| Maximum PowerDensity (W/cm2, 500Ω,r.m.s) | TENS mode: | 0.072 | 0.74 mW/cm² | ||
| R-C3, R-C4C and R-C4D: 0.28 mW/cm² | |||||
| R-C4A: 0.28 mW/cm² | |||||
| R-C4B: 0.24 mW/cm² | |||||
| EMS mode: R-C3, R-C4C and R-C4D:0.23 mW/cm² | 0.072 | 0.74 mW/cm² | |||
| R-C4A: 0.29 mW/cm² | |||||
| R-C4B: 0.29 mW/cm² | |||||
| Electrode area (cm2) | 25 | 25 | 25 | Same | |
| a. Pulses per burst | 25 | 25 | 25 | Same | |
| b. Bursts per second | 2 | 2 | 2 | Same | |
| c. Burst duration(seconds) | 250ms | 250ms | 250ms | Same | |
| d. Duty Cycle [Line (b) xLine (c)] | 500ms | 500ms | 500ms | Same | |
| 1. Electrodes | self-adhesive electrode (50mm x 50mm) | self-adhesive electrode (50mm x 50mm) | self-adhesive electrode (50mm x 50mm) | Same | |
| Item | Primary predicate device(K192087) | Reference Predicate device(K181688&180956) | Subject Device(K231423) | Discussion | |
| 2. Electrode ConductiveMedium (Gel) | self-adhesive electrode with conductivemedia (gel) | self-adhesive electrode with conductivemedia (gel) | self-adhesive electrode with conductivemedia (gel) | Same | |
| 3. Electrode Lead Wiresand Patient Cables | self-adhesive electrode with ElectrodeLead Wires | self-adhesive electrode with Electrode LeadWires | self-adhesive electrode with ElectrodeLead Wires | Same | |
| 4. Batteries | R-C3, R-C4A and R-C4C:DC 3.7 V/600mAh Li-ion batteryR-C4B and R-C4D: DC 4.5V, 3 ×AAAbatteries | Battery powered, d.c. 6.0V, 4 X AAAbatteries | R-C101D,R-C101G,R C101C,F100,MINI-TENS-COMB:3.7V D.C.,Li-ionbatteriesR-C101F,R-C101I,TENS3500:9Vbatteries | Similar, but the subjectdevice is in compliance withrequirements of IEC 60601-1 | |
| 5. Battery Charger | NA | NA | NA | Same |
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Analysis for the differences:
Note 1: difference in Patient Leakage Current
The patient leakage current under SINGLE FAULT Concess is higher than the predicate, but it neets the requirements of EC 6061-1. According to requirements of Table 3 of 8.7.3 Allowable values, IEC 60601-1 (see the tables, patient leakage current under SINGLE FAULT CONDITION should be less than 500 a. Though patient leakage current under SINGLE of our devices is different from the predicate device, it is below 500 uA and meets the requirements of EC 6001-1, which demonstrate the subject device does not cause any safety or effectiveness risks.
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Table 3 - * Allowable values of PATIENT LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS under NORMAL CONDITION and SINGLE FAULT CONDITION
| Current | Description | Reference | MeasuringCircuit | TYPE BAPPLIEDPART | TYPE BFAPPLIEDPART | TYPE CFAPPLIEDPART | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| NC | SFC | NC | SFC | NC | SFC | |||||
| PATIENTAUXILIARYCURRENT | 8.7.4.8 | Figure 19 | d.c.a.c. | 10100 | 50500 | 10100 | 50500 | 1010 | 5050 | |
| PATIENTLEAKAGECURRENT | From PATIENTCONNECTION toearth | 8.7.4.7 a) | Figure 15 | d.c.a.c. | 10100 | 50500 | 10100 | 50500 | 1010 | 5050 |
| Caused by anexternal voltageon a SIP/SOP | 8.7.4.7 c) | Figure 17 | d.c.a.c. | 10100 | 50500 | 10100 | 50500 | 1010 | 5050 | |
| TotalPATIENTLEAKAGECURRENT * | With the sametypes of APPLIEDPART connectedtogether | 8.7.4.7 a)and8.7.4.7 h) | Figure 15andFigure 20 | d.c.a.c. | 50500 | 1001 000 | 50500 | 1001 000 | 5050 | 100100 |
| Caused by anexternal voltageon a SIP/SOP | 8.7.4.7 c)and8.7.4.7 h) | Figure 17andFigure 20 | d.c.a.c. | 50500 | 1001 000 | 50500 | 1001 000 | 5050 | 100100 | |
| Key | ||||||||||
| NC = NORMAL CONDITIONSFC = SINGLE FAULT CONDITION | ||||||||||
| NOTE 1 For EARTH LEAKAGE CURRENT see 8.7.3 d). | ||||||||||
| NOTE 2 For TOUCH CURRENT see 8.7.3 c). |
Current in uA
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Note 2: Difference in Maximum Output Voltage and Maximum Output Current
There are some differences on the maximum output current tetween the proposed device and predicate device. Based on the calculation of maximum current density, maximum areage power density, these the safety limit. and these parameers have passed IEC 6060 - 2-10 test occess will not rase any new safety and effectiveness issues. Although the period and frequency of the proposed device are a lifte different from the predicate ovide on the varia IEC 60601-2-10 requirements. So, the minor differences of function 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 and pulculation: pulse with: 4500S, Frequency: 1.50 Hz, max output corrent: 90mA, electrodes: 50 x 50mm
- 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 EMS mode, Select the maximum for calculation: pulse width: 4500S, Frequency: 1.50 Hz, max output corrent: 90mA, electroder: 50 x 50mm
- 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
Above all, although There are some differences on the nextinum power densiny, busts per second, bust duration and duty cycle between the proposed device and the predicate device, but these paranteers don't and have passed IEC (0601-2-10 test. the Maximum Current Density of the subject deriver is lover than 2 m 4 cn2 refer to "IEC6001-2-10 Clause 2014.2" and the Mainten Avener of Coutance Dounnet for Powered Nuscle Simulator 10/kk (page 16 section 3 "Maximum currently values should be calculated using the conductive surface area of the smallest electrodes provided for use with the unit; sample calculations should be provided. The maximum duty cycle and should be averaged over an output duration of one second. The maximum power density should be less than 0.25 Wats' of themal burns.") , Therefore, these differences won't raise any new safety and effectiveness risk.
Discussion:
By the comparison between items of new devices of predicate devices one by one as listed in above tables, it can be seen that, all different times would not adversely impact safety and effectiveness of the subject device as the reasons are listed in the above table.
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The RW series C Combo Electrotherapy Device (Model:R-C101G,R-C101G, F100,MIN-TENS-COMB,R-C101,TENS3500) has been compared with RW series B Combo Electrotherspy Device (R-C-S-R-C-Cand R-C-D-K192087). The subject device has many Same and Similar items as that predicate devices, such as intended of operation, technological characteristics etc. Although there are several specifications that are different among those two devices, the comparison and the differences among these parameters would not adversely impact the safety and effectiveness of the subject device has undergone safety and performance tests, and the results complied with the test requests. Therefore, the difference between the predicate device device device did not raise any problem of subject device is substantially equivalent to the predicate devices.
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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 serial,and 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-C101D.R-C101F.R-C101G.F100.MNI-TENS-COMB,R-C1011, TENS3500) 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. which had been submitted with Shenzhen Roundwhale Technology Co., Ltd.(K222252) which has been evaluated based on the ISO10993 standard and submitted to FDA.
7.3 Safety and EMC
Electrical safety and EMC testing were conducted on the Combo Electrotherapy Device (Model:R-C101C,R-C101D,R-C101F,R-C101G,F100,MINI-TENS-COMB,R-C1011, TENS3500),, 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-C101C,R-C101F,R-C101G,F100,MINI-TENS-COMB,R-C1011, TENS3500),consisting of all the accessories in 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:
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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 devices in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with international standards.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).