Search Results

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.

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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Model:R-C101W:

• For TENS/IF/MIC mode
• 1. Symptomatic relief of chronic intractable pain
• 2. Post traumatic pain
• 3. Post surgical pain
• For EMS/RUSS mode
• 1. Relaxation of muscle spasm.
• 2. Increase of local blood flow circulation
• 3. Prevention or retardation of disuse atrophy
• 4. Muscle re-education
• 5. Maintaining or increasing range of motion.
• 6. Immediate post-surgical stimulation of muscles to prevent venous thrombosis

Model:R-C101A

• For TENS/IF mode
• 1. Symptomatic relief of chronic intractable pain.
• 2. Post traumatic pain.
• 3. Post surgical pain.
• For EMS/RUSS mode
• 1. Relaxation of muscle spasm.
• 2. Increase of blood flow circulation.
• 3. Prevention or retardation of disuse atrophy.
• 4. Muscle re-education.
• 5. Maintaining or increasing range of motion.
• 6. Immediate post-surgical stimulation of muscles to prevent venous thrombosis

Model:R-C101B
For TENS/IF mode

• 1. Symptomatic relief of chronic intractable pain
• 2. Post traumatic pain
• 3. Post surgical pain
• For EMS/RUSS mode
• 1. Relaxation of muscle spasm.
• 2. Increase of local blood flow circulation
• 3. Prevention or retardation of disuse atrophy
• 4. Muscle re-education
• 5. Maintaining or increasing range of motion.
• 6. Immediate post-surgical stimulation of muscles to prevent venous thrombosis

Model:R-C101E
For IF mode

• 1. Symptomatic relief of chronic intractable pain
• 2. Post traumatic pain
• 3. Post surgical pain
     For RUSS mode
• 1. Relaxation of muscle spasm.
• 2. Increase of local blood flow circulation
• 3. Prevention or retardation of disuse atrophy
• 4. Muscle re-education
• 5. Maintaining or increasing range of motion.
• 6. Immediate post-surgical stimulation of muscles to prevent venous thrombosis

Model:R-C101H
For TENS and IF mode

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

Model:R-C101D
For TENS mode

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

Model:R-C101G
For TENS mode

• 1. Symptomatic relief of chronic intractable pain.
• 2. Post traumatic pain.
• 3. Post surgical pain.
     For EMS mode
• 1. Relaxation of muscle spasm.
• 2. Increase of local blood flow circulation
• 3. Prevention or retardation of disuse atrophy
• 4. Muscle re-education
• 5. Maintaining or increasing range of motion.

6. Immediate post-surgical stimulation of muscles to prevent venous thrombosis

The Combo Electrotherapy Device (Models: R-C101W, R-C101B, R-C101E, R-C101H, R-C101D, and R-C101G) is a Transcutaneous Electrical Nerve Stimulator. The device features two independent output channels and four selfadhesive electrode gel pads. The stimulator sends a gentle electrical current to the underlying nerves and muscle groups via electrodes applied on the skin. Users can choose from pre-set programs or specify their own to suit their individual needs. All controls and indicators are controlled by software which also controls waveform characteristics. The 7 models have similar housing with a viewable LCD display and an accessible keypad. The LCD is located on the upper half of the rectangular face of the device above the keypad. It is used to display system information to the user. The device is battery-powered but can be connected to an external power supply its internal battery which is a non-user serviceable or accessible 3.7V D.C., Li-ion battery. There are only two external connections on the device - power input and electrode connector - with no connection to any other devices. The Battery Charger is not included in the package; however, users can choose adapters that meet IEC 60601-1 medical stardards.

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

Study Proving Acceptance Criteria:

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

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

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Over-The-Counter Use:

TENS mode::

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.

EMS mode:

This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

Prescription Use:

For TENS mode:

• 1. Symptomatic relief of chronic intractable pain:
• 2. Post traumatic pain: 3) Post surgical pain;

For EMS mode:

• 1. Relaxation of muscle spasm;
• 2. Increase of local blood flow circulation;
• 3. Prevention or retardation of disuse atrophy;
• 4. Muscle re-education;
• 5. Maintaining or increasing range of motion;
• 6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Not Found

This document is a 510(k) clearance letter from the FDA for a Combo Electrotherapy Device. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way a clinical study report for an AI/ML device would. The letter primarily confirms the device's substantial equivalence to predicate devices and lists the indications for use.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies from the provided text. This document is a regulatory clearance, not a performance study report.

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