(84 days)
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.
The device of the model TU3424-F is a portable, battery powered (lithium battery 3.7V DC) multifunction device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (EMS) qualities in one device, it can be used for arm, shoulder, neck, back, waist, abdomen, and leg. 4 channels that effectively transfer your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. There are 24 modes of operations. The electrode pads are cleared by FDA, and 510(k) number is K092546 for the electrode pads. They are used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current is first transmitted via the lead wire or snap button then transmitted to the conductive gel which is adhered to patient skin. The electrode pads are composed of a cover, connector lead wire or snap button, conductive carbon film, conductive hydrogel, and an electrode carrier liner. It is non-sterile and intended for single adult patient (age ≥ 18) multiple application use. Its output waveform is provided 24 programs and 20 adjustable intensity levels. The LCD screen shows the information of program, level, operating time and channel.
This is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) & Powered Muscle Stimulator (EMS) device, indicating that its substantial equivalence to a predicate device was established based on non-clinical performance data and adherence to recognized standards. A clinical study proving acceptance criteria is not applicable for this type of submission, as the FDA has determined that clinical data is not required to demonstrate substantial equivalence for these devices.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to a legally marketed predicate device (K202866, Model: FM-B2403) by meeting recognized voluntary standards and confirming that performance differences do not raise new safety or effectiveness concerns.
| Acceptance Criteria (based on predicate equivalence and standards) | Reported Device Performance (New device: TU3424-F) |
|---|---|
| Regulatory Information: Aligns with predicate for regulation numbers (21 CFR 882.5890, 21 CFR 890.5850), classification (Class II), and product codes (NUH, NGX). | SE (Substantially Equivalent) |
| Intended Use: Identical indications for TENS and EMS. | SE (Substantially Equivalent) |
| Applied Parts of the Body: Identical areas for application. | SE (Substantially Equivalent) |
| Power Source: Built-in 3.7V lithium battery. | SE (Substantially Equivalent) |
| Method of Line Current Isolation: BF | SE (Substantially Equivalent) |
| Patient Leakage Current: Normal condition <10µA; Single fault condition <50µA. | SE (Substantially Equivalent) |
| Number of Output Channels: 4 | SE (Substantially Equivalent) |
| Synchronous or Alternating: Synchronous | SE (Substantially Equivalent) |
| Method of Channel Isolation: By electrical circuit and software. | SE (Substantially Equivalent) |
| Regulated Current or Voltage: Regulated voltage control. | SE (Substantially Equivalent) |
| Software/Firmware/Microprocessor Control: Software. | SE (Substantially Equivalent) |
| Automatic Overload Trip: No | SE (Substantially Equivalent) |
| Automatic No-Load Trip: No | SE (Substantially Equivalent) |
| Automatic Shut Off: Yes | SE (Substantially Equivalent) |
| Patient Override Control: Yes | SE (Substantially Equivalent) |
| On/Off Status: Yes | SE (Substantially Equivalent) |
| Low Battery Indicator: Yes | SE (Substantially Equivalent) |
| Voltage/Current Level Indicator: Yes | SE (Substantially Equivalent) |
| Timer Range (minutes): 10-80 | SE (Substantially Equivalent) |
| Waveform: Biphasic | SE (Substantially Equivalent) |
| Shape: Rectangular | SE (Substantially Equivalent) |
| Net Charge (µC per pulse): 0.0001µC @500Ω (Predicate 0.001µC @500Ω) | SE (Substantially Equivalent) - Note 2 states that this difference won't raise new risks and passed IEC 60601-2-10. |
| Pulses per burst: 2 | SE (Substantially Equivalent) |
| ON Time (seconds): 1 | SE (Substantially Equivalent) |
| OFF Time (seconds): 1 | SE (Substantially Equivalent) |
| Compliance with Voluntary Standards: ANSI/AAMI/ES 60601-1, IEC60601-1-2, IEC 60601-2-10, IEC60601-1-11, ISO10993-5, ISO10993-10. | Compliant (Stated as having passed these tests) |
| Biocompatibility: All user-contacting materials comply with ISO10993-5 and ISO10993-10. | Compliant |
| Software Verification: Compliant with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. | Compliant |
| Maximum Output Voltage (volts) (+/- 10%): 60@500Ω, 95@2KΩ, 153@10kΩ (Predicate: 97.6@500Ω, 135@2KΩ, 157@10KΩ) | SE (Substantially Equivalent) - Note 1 states that these differences won't raise new risks and passed IEC 60601-2-10. |
| Maximum Output Current (mA) (+/- 10%): 120@500Ω, 47.5@2kΩ, 15.3@10kΩ (Predicate: 195.2@500Ω, 67.5@2KΩ, 15.7@10KΩ) | SE (Substantially Equivalent) - Note 1 states that these differences won't raise new risks and passed IEC 60601-2-10. |
| Pulse Duration (us): 50-300 (Predicate: 90) | SE (Substantially Equivalent) - Note 1 states that these differences won't raise new risks and passed IEC 60601-2-10. |
| Frequency (Hz) [or Rate (pps)]: <200 Hz (Predicate: < 90.9) | SE (Substantially Equivalent) - Note 1 states that these differences won't raise new risks and passed IEC 60601-2-10. |
| Maximum Phase Charge (µC): 36@500Ω (Predicate: 15.5@500Ω) | SE (Substantially Equivalent) - Note 2 states that these differences don't exceed safety limits and passed IEC 60601-2-10. |
| Maximum Current Density (mA/cm²): 0.3456@500Ω (Predicate: 0.1192@500Ω) | SE (Substantially Equivalent) - Note 2 states that these differences don't exceed safety limits and passed IEC 60601-2-10. |
| Maximum Power Density (mW/cm²): 1.4930@500Ω (Predicate: 0.176@500Ω) | SE (Substantially Equivalent) - Note 2 states that these differences don't exceed safety limits and passed IEC 60601-2-10, and the maximum average power density <0.25Watts/cm². |
| Bursts per second: 0.02 (Predicate: 1/30) | SE (Substantially Equivalent) - Note 2 states that these differences don't exceed safety limits and passed IEC 60601-2-10. |
| Burst duration (ms): 50 (Predicate: 45) | SE (Substantially Equivalent) - Note 2 states that these differences don't exceed safety limits and passed IEC 60601-2-10. |
| Duty Cycle: 6.0 (Predicate: 1.6%) | SE (Substantially Equivalent) - Note 2 states that these differences don't exceed safety limits and passed IEC 60601-2-10. |
| Number of Output Modes: TENS:10, EMS:5 (New device: TENS:19, EMS:5) | SE (Substantially Equivalent) - Predicate shown TENS:10, EMS:5, New device shows TENS:19, EMS:5. The table has a mismatch here. Based on the "comparison in details" table, the new device has TENS:19, EMS:5, while the predicate has TENS:10, EMS:5. However, since the final conclusion states SE based on non-clinical tests, it's implied that these differences are not considered to raise new safety/effectiveness risks. |
Note: The table in the document has inconsistencies for "Number of Output Modes". The "Predicate Device" column lists "TENS:10, EMS:5" next to the new device's "TENS:19, EMS:5" but then also lists the new device's values in its own column under "New device". The interpretation above assumes the "New device" column accurately describes the proposed device and the "Predicate Device" column describes the predicate. The "SE" in the table signifies that despite these differences, the device is considered substantially equivalent.
Conclusion from document: "After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that the model TU3424-F is substantially equivalent to the predicate device K202866 (Model: FM-B2403)."
2. Sample size used for the test set and the data provenance
Not applicable. This submission is for a TENS/EMS device and relies on non-clinical performance and safety testing against recognized standards to demonstrate substantial equivalence to a predicate device, rather than a clinical study with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set requiring expert ground truth was performed for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring adjudication was performed for this 510(k) submission.
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 TENS/EMS stimulator, not an AI-powered diagnostic or interpretive device, and therefore no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical stimulator and does not involve a diagnostic algorithm for standalone performance evaluation. Its performance is assessed through electrical safety and performance testing, and biocompatibility.
7. The type of ground truth used
The "ground truth" for this submission is established through:
- Compliance with recognized voluntary standards: ANSI/AAMI/ES 60601-1, IEC60601-1-2, IEC 60601-2-10, IEC60601-1-11, ISO10993-5, ISO10993-10. These standards define the acceptable safety and performance characteristics for such devices.
- Comparison to a legally marketed predicate device (K202866): The predicate device's established safety and effectiveness serves as a reference point.
- Non-clinical laboratory studies and safety testing data: These tests directly evaluate the device's electrical output parameters, safety features, and material biocompatibility against the requirements of the standards and comparisons to the predicate.
8. The sample size for the training set
Not applicable. This is a hardware device submission for a TENS/EMS stimulator, not an AI/machine learning algorithm, and therefore does not involve a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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March 3, 2022
Shenzhen Jian feng Electronic Technology Co. Ltd. Feng Wen GM 902,903 Jialingyu Industrial Building, Da Pu Road Houting Village, Shajing Town, Baoan District Shenzhen, Guangdong 518104 China
Re: K213835
Trade/Device Name: TENS & EMS Device Regulation Number: 21 CFR 882.5890; 21 CFR 890.5850 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief: Powered muscle stimulator Regulatory Class: Class II Product Code: NUH, NGX Dated: December 9, 2021 Received: December 9, 2021
Dear Feng Wen:
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 (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 located 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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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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.
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine 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) K213835
Device Name TENS & EMS Device
Indications for Use (Describe) TENS:
The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
EMS:
The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
|X| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
Type of 510(k) submission: Traditional
Date of the summary prepared: Jan-30-2022
Submitter's Information
Submitter: SHENZHEN JIAN FENG ELECTRONIC TECHNOLOGY CO., LTD.
Address: 902, 903 Jialingyu Industrial Building, Da Pu Road, Houting Village, Shajing Town, Baoan District, Shenzhen City, Guangdong Province, China.
Contact Person: Feng Wen
Email: wenfeng@fzjhealth.com
Tel: +86-755-33858361 Fax: +86-755-33858360
Application Correspondent
Company: SHENZHEN JIAN FENG ELECTRONIC TECHNOLOGY CO., LTD.
Address: 902, 903 Jialingyu Industrial Building, Da Pu Road, Houting Village, Shajing Town, Baoan District, Shenzhen City, Guangdong Province, China.
Contact Person: Fenq Wen
Title: General Manager
Email: wenfeng@fzjhealth.com
Tel: +86-755-33858361 Fax: +86-755-33858360
The Predicate Device Information
| Basic Information | Predicate Device |
|---|---|
| Manufacturer | Shenzhen Jian Feng Electronic Technology Co., Ltd. |
| Device Name | TENS & EMS Device |
| Model | FM-B2403 |
| 510(K) Number | K202866 |
| Product Code | NUH, NGX |
| Panel Code | Physical Medicine, Neurology |
| Regulation Number | 21 CFR 882.5890 |
| 21 CFR 890.5850 | |
| Regulation Class | Class II |
Subject Device Information
Trade Name: TENS & EMS Device Common Name: TENS, EMS, Stimulator for pain relief; Classification Name: Transcutaneous electrical nerve stimulator for pain relief; Powered muscle stimulator Review Panel: Physical Medicine; Neurology
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Product Code: NUH,NGX Regulation Number: 21CFR882.5890, 21CFR890.5850 Device Classification: Class II Use: Over-the-Counter Use (OTC)
Device Description / Design of Device
The device of the model TU3424-F is a portable, battery powered (lithium battery 3.7V DC) multifunction device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (EMS) qualities in one device, it can be used for arm, shoulder, neck, back, waist, abdomen, and leg.
4 channels that effectively transfer your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. There are 24 modes of operations.
The electrode pads are cleared by FDA, and 510(k) number is K092546 for the electrode pads. They are used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current is first transmitted via the lead wire or snap button then transmitted to the conductive gel which is adhered to patient skin. The electrode pads are composed of a cover, connector lead wire or snap button, conductive carbon film, conductive hydrogel, and an electrode carrier liner. It is non-sterile and intended for single adult patient (age ≥ 18) multiple application use.
Its output waveform is provided 24 programs and 20 adjustable intensity levels. The LCD screen shows the information of program, level, operating time and channel.
Indication for Use
TENS:
The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
EMS:
The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.
Technological characteristics and substantial equivalence The following table is the basic characteristic:
| Contents | New device | Predicate Device | SE |
|---|---|---|---|
| Trade Name | TENS & EMS Device | TENS & EMS Device | SE |
| Device Model | TU3424-F | FM-B2403 | / |
| 510(k) Number | K213835 | K202866 | / |
| Manufacturer | Shenzhen Jian Feng ElectronicTechnology Co., Ltd. | Shenzhen Jian Feng ElectronicTechnology Co., Ltd. | SE |
| Regulatory Information | 882.5890, 890.5850 | 882.5890, 890.5850 | SE |
| Classification | Class II | Class II | SE |
| Product code | NUH, NGX | NUH, NGX | SE |
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| Panel | Physical Medicine; Neurology | Physical Medicine; Neurology | SE | |
|---|---|---|---|---|
| OTC/RX | OTC | OTC | SE | |
| Intended Use | TENS: The device is designed tobe used for temporary relief of painassociated with sore and achingmuscles in the shoulder, waist,back, neck, upper extremities(arm), lower extremities (leg),abdomen and bottom due to strainfrom exercise or normal householdwork activities.EMS: The device is designed to beused to stimulate healthy musclesin order to improve or facilitatemuscle performance. | TENS: The device is designed tobe used for temporary relief of painassociated with sore and achingmuscles in the shoulder, waist,back, neck, upper extremities(arm), lower extremities (leg),abdomen and bottom due to strainfrom exercise or normal householdwork activities.EMS: The device is designed to beused to stimulate healthy musclesin order to improve or facilitatemuscle performance. | SE | |
| Apply parts of the body | Shoulder, waist, back, neck, upperextremities (arm), lower extremities(leg), abdomen and bottom | Shoulder, waist, back, neck, upperextremities (arm), lower extremities(leg), abdomen and bottom | SE | |
| Power Source | Built-in 3.7V lithium battery | Built-in 3.7V lithium battery | SE | |
| - Method of Line CurrentIsolation | BF | BF | SE | |
| - Patient Leakage Current | / | / | ||
| - Normal condition | <10μΑ | <10μΑ | SE | |
| - Single fault condition | <50μΑ | <50μΑ | SE | |
| Number of Output Modes | TENS:10, EMS:5 | TENS:19, EMS:5 | SE | |
| Number of Output Channels | 4 | 4 | SE | |
| Synchronous or alternating | Synchronous | Synchronous | SE | |
| Method of Channel Isolation | By electrical circuit and software | By electrical circuit and software | SE | |
| Regulated Current orRegulated Voltage | Regulated voltage control | Regulated voltage control | SE | |
| Software/Firmware/Microprocessor Control? | Software | Software | SE | |
| Automatic Overload Trip? | No | No | SE | |
| Automatic No-Load Trip? | No | No | SE | |
| Automatic Shut Off? | Yes | Yes | SE | |
| Patient Override Control? | Yes | Yes | SE | |
| On/Off Status? | Yes | Yes | SE | |
| Low Battery? | Yes | Yes | SE | |
| Voltage/CurrentLevel? | Yes | Yes | SE | |
| Timer Range (minutes) | 10~80 | 10~80 | SE | |
| Compliance with VoluntaryStandards? | Yes. | Yes | SE | |
| ANSI/AAMI/ES 60601-1 | ANSI/AAMI/ES 60601-1 | |||
| IEC60601-1-2 | IEC60601-1-2 | |||
| IEC 60601-2-10 | IEC 60601-2-10 | |||
| IEC60601-1-11 | IEC60601-1-11 | |||
| ISO10993-5ISO10993-10 | ISO10993-5ISO10993-10 | |||
| Accessories | Self-adhesive electrodes,electrode wires, adapter, USBcable | Self-adhesive electrodes,electrode wires, adapter, USBcable | SE | |
| Compliance* with 21 CFR898? | Yes | Yes | SE | |
| Weight(g) | 110 | 82 | SE,Note 1 | |
| Dimensions (mm) [D x W H] | 1616016.5 | 1106015 | SE | |
| Housing Materials andConstruction | ABS | ABS | SE | |
| Biocompatibility | All user directly contactingmaterials are compliance withISO10993-5 and ISO10993-10requirements | All user directly contactingmaterials are compliance withISO10993-5 and ISO10993-10requirements | SE | |
| Comparison in details:Note 1: |
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The proposed device TU3424-F has passed the IEC 60601-1 and AAMI / ANSI ES60601-1 test . The weight, dimensions, appearance of proposed device TU3424-F has a little different from predicate device K202866, but these differences are insignificant and won't raise any new risk of safety and effectiveness..
The following table is the output parameters:
| Contents | Proposed Device | Predicate Device | SE |
|---|---|---|---|
| Device Name, Model | TU3424-F | FM-B2403 | / |
| Waveform (e.g., pulsed monophasic,biphasic) | Biphasic | biphasic | SE |
| Shape (e.g., rectangular, spike,rectified sinusoidal) | Rectangular | rectangular | SE |
| Maximum Output Voltage (volts) (+/-10%) | 60@500Ω95@2KΩ153@10kΩ | 97.6@500Ω135@2KΩ157@10KΩ | SENote 1 |
| Maximum Output Current (mA) (+/-10%) | 120@500Ω47.5@2kΩ15.3@10kΩ | 195.2@500Ω67.5@2KΩ15.7@10KΩ | SENote 1 |
| Pulse Duration (us) | 50-300 | 90 | SE,Note 1 |
| Frequency† (Hz) [or Rate† (pps)] | <200 Hz | < 90.9 | SENote 1 |
| Net Charge (micro coulombs (μC)per pulse) (If zero, state method ofachieving zero net charge.) | 0.0001μC @500Ω | 0.001μC @500Ω | SE |
| Maximum Phase Charge, (μC) | 36@500Ω | 15.5@500Ω | SENote 2 |
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| Maximum Current Density(mA/cm²) | 0.3456@500Ω | 0.1192@500Ω | SENote 2 |
|---|---|---|---|
| Maximum Power Density(mW/cm²) | 1.4930@500Ω | 0.176@500Ω | SENote 2 |
| Pulses per burst | 2 | 2 | SE |
| Bursts per second | 0.02 | 1/30 | SENote 2 |
| Burst duration (ms) | 50 | 45 | SENote 2 |
| Duty Cycle: Line (b) x Line (%) | 6.0 | 1.6% | SENote 2 |
| ON Time (seconds) | 1 | 1 | SE |
| OFF Time (seconds) | 1 | 1 | SE |
Comparison:
Note 1: There are some differences on the maximum output voltage ,maximum Output current, pulse duration, frequency between proposed device and predicate device K202866.All these parameters have passed IEC 60601-2-10 test codes. Therefore, these differences won't raise any new risk of safety and effectiveness.
Note 2:There are some differences on the net charge, maximum current density ,maximum power density, bursts per second, burst duration and duty cycle between the proposed device and the predicate device K202866,but these parameters don't exceed the safety limit and have passed IEC 60601-2-10 test. The maximum average power density <0.25Watts/cm²,Therefore, these differences won't raise any new safety and effectiveness risk.
Non-Clinical Tests Performed
Compliance to applicable voluntary standards include: ANSI/AAMI/ES 60601-1. IEC60601-1-2. IEC 60601-2-10, IEC60601-1-11.
In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Final conclusion:
After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that the model TU3424-F is substantially equivalent to the predicate device K202866 (Model: FM-B2403).
§ 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).