(90 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 (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 and facilitate muscle performance.
Transcutaneous Electrical Nerve Stimulator is a portable and DC 3.7V battery powered multifunction device that adopts modern electronic science and technology to delivers electric pulses generated to the electrodes. It has two functions: Transcutaneous electrical nerve stimulation(TENS) and Electrical muscle stimulation (EMS).
The device has 20 operation programs. It includes operating elements of Power ON/OFF button, intensity decrease button, Menu selection button, and A/B channel selection button.
The display screen can show battery power, program, mode, keylock status, intensity level, treatment time and output channel. The device is equipped with accessories of electrode cables, and one Type-C cable. The electrode cables are used to connect the pads to the device; the Type-C cable is used to connect the charger and the built-in lithium battery.
In additional, according to different simulation-needed bodies, users can choose the three types of electrode pad based on their own situation. The electrode pads are manufactured by ShenZhen Technology Co., Ltd with 510(k) cleared Number K171381.
The provided document is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device. This type of filing does not contain detailed clinical study data or acceptance criteria in the format typically used for AI/ML device evaluations. Instead, it demonstrates substantial equivalence to predicate devices primarily through non-clinical performance and a comparison of technical specifications.
Therefore, I cannot extract information related to acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these are not typically included or required in a non-clinical 510(k) submission for a TENS device.
However, I can extract the available information regarding the device's technical specifications and how its performance is compared to predicate devices, focusing on the "Substantial Equivalence Comparison" tables.
Here's a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define "acceptance criteria" for clinical performance. Instead, it compares the subject device's technical specifications to those of predicate devices to establish substantial equivalence. The "reported device performance" refers to the subject device's specifications and its compliance with relevant international standards.
Here's a table summarizing key technical specifications and their comparison to predicate devices, drawing from the "Substantial Equivalence Comparison" tables. "Acceptance Criteria" here are implicitly defined by the ranges and characteristics observed in the predicate devices and compliance with relevant standards.
| Element of Comparison | Acceptance Criteria (Implied by Predicate Range/Compliance) | Reported Device Performance (Subject Device K6106) | Comparison Result |
|---|---|---|---|
| General | |||
| Product Code | NUH, NGX, NYN, GZJ, IPF, IRT (covered by predicates) | NUH, NGX | Same (within the scope of predicate product codes) |
| Regulation Number | 21 CFR 882.5890, 21 CFR 890.5850 | 21 CFR 882.5890, 21 CFR 890.5850 | Same |
| Prescription/OTC | OTC | OTC | Same |
| Intended Use | Temporary relief of pain (TENS); Muscle performance improvement (EMS) covering specific body parts | Identical to primary predicate for TENS and EMS indications | Same |
| Power Supply | Internal/rechargeable batteries (e.g., 3x1.5V AAA, 3.7V lithium) | Internal battery: 3.7Vd.c. 300mAh | Same (within typical battery specifications for such devices) |
| Method of Line Current Isolation | Type BF/Battery supply/Voltage transformer isolation | Type BF | Same (Type BF is a recognized isolation type) |
| Patient Leakage Current | <10 µA (Normal), <50 µA (Single Fault) (Based on predicate/standard limits) | <1 µA (Normal), <1 µA (Single Fault) | Same (Meets or exceeds predicate/standard safety levels) |
| Number of Output Modes | 1 to 50 modes (Across predicate devices) | TENS: 10, EMS: 10 (Total 20) | Similar (Subject device's 20 modes are within the range observed in predicates, and comply with IEC 60601-2-10 and AAMI/ANSI ES60601-1, per Note 2) |
| Number of Output Channels | 1, 2, or 4 channels | 4 | Same (within predicate range) |
| Software/Firmware/Microprocessor Control | Yes (Standard for these devices) | Software | Same |
| Automatic Shut-off | Yes | Yes | Same |
| Timer Range | 10-540 minutes (Across predicates) | 10-60 minutes | Similar (Subject device's range is included within predicate's ranges and is user-adjustable based on need, per Note 1) |
| Compliance with Voluntary Standards | IEC 60601-1, -1-2, -1-11, -2-10, ISO 10993, AAMI/ANSI ES60601-1 (Covered by predicates) | IEC 60601-1, -1-2, -1-11, -2-10 | Same (Subject device complies with relevant safety and performance standards for TENS/EMS devices) |
| Electrical Output Parameters | |||
| Waveform | Biphasic/Square/Symmetrical biphasic/Pulsed, symmetric, biphasic | Biphasic | Same (Falls within the common waveforms of predicate devices, per Note 3) |
| Maximum Output Voltage at 500 Ω | 50-68V (Observed in predicates) | 68V | Similar (Within predicate ranges and complies with standards, per Note 3) |
| Maximum Output Current at 500 Ω | 104-200mA (Observed in predicates) | 136mA | Similar (Within predicate ranges and complies with standards, per Note 3) |
| Frequency (Hz) | 1-500 Hz (Observed in predicates) | 2-80 Hz | Similar (Within predicate ranges and complies with standards, per Note 4) |
| Pulse Duration (μs) | 50-500µS (Observed in predicates) | 120-400μS | Similar (Within predicate ranges and complies with standards, per Note 4) |
| Maximum Phase Charge at 500 Ω | 17-78 μC (Observed in predicates) | 65.82 μC | Similar (Within predicate ranges and complies with standards, per Note 5) |
| Maximum Current Density at 500 Ω | 0.08-1.86 mA/cm² (Observed in predicates) | 1.001 mA/cm² | Similar (Within predicate ranges and complies with standards, per Note 5) |
| Max. Average Current at 500 Ω | 1.88-24.33 mA (Observed in predicates) | 24.33 mA | Similar (Within predicate ranges and complies with standards, per Note 5) |
| Maximum Average Power Density W/cm² at 500 Ω | Max < 0.25 W/cm² (per FDA guidance) | 0.0122 W/cm² | Similar (Meets the FDA guidance requirement and falls within predicate ranges, per Note 5) |
| Average DC current through electrodes when device is on but no pulses are being applied (µA) | 0 or < 0.01μA (Observed in predicates) | 0 | Same |
Regarding the study that proves the device meets (these implicit) acceptance criteria:
The document relies on non-clinical performance testing to demonstrate that the subject device (K6106) meets the safety and effectiveness requirements, primarily by showing compliance with recognized international standards and substantial equivalence to legally marketed predicate devices.
The studies referenced are:
- Compliance with International Standards for Medical Electrical Equipment:
- IEC 60601-1:2005+A1:2012+A2:2020 (General Requirements for Safety)
- IEC 60601-2-10:2012+A1:2016 (Particular requirements for nerve and muscle stimulators)
- IEC 60601-1-2:2014+A1:2020 (Electromagnetic compatibility)
- IEC 60601-1-11:2015 (Requirements for medical electrical systems used in the home healthcare environment)
- Software Validation: FDA software validation guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on: January 11, 2002". (Though no specific study details are provided, compliance with this guidance is stated).
- Guidance for Product-Specific Requirements: "Guidance Document for Powered Muscle Stimulator 510(k)s Document issued on: June 9, 1999."
The general conclusion is that "The electrical safety, EMC, biocompatibility, software verification, and output specifications information provided is sufficient to demonstrate substantial equivalence to the Transcutaneous Electrical Nerve Stimulator, model: K6106 is nearly identical to the predicate devices, differences in their characteristics do not raise new questions regarding safety and effectiveness with identical indications for use and essentially identical technological characteristics..." (Page 7).
Non-Applicable Sections for this document type:
- Sample sized used for the test set and the data provenance: Not applicable. This is a non-clinical submission. No clinical test set data is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert ground truth is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication is described.
- 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 device, not an AI/ML diagnostic or image analysis device that would typically involve human readers or AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a non-clinical TENS/EMS device submission. Ground truth for safety and performance is based on compliance with electrical, mechanical, and biological standards.
- The sample size for the training set: Not applicable. This device does not use a "training set" in the context of AI/ML.
- How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
July 22, 2024
Shenzhen Yicai Health Technology Co., Ltd. Xie Jie General Manager 11th floor, Zhenqian Building, Yousong Community, Longhua Street, Longhua District Shenzhen, 518110 China
Re: K241119
Trade/Device Name: Transcutaneous Electrical Nerve Stimulator (K6106) 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, NGX Dated: April 22, 2024 Received: April 23, 2024
Dear Xie Jie:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Robert Kang -S
for Pamela Scott Assistant Director 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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Transcutaneous Electrical Nerve Stimulator (K6106)
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 (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 and 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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| 510(k) Summary | Prepared on: 2024-07-11 | |
|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | |
| Applicant Name | Shenzhen Yicai Health Technology Co., Ltd. | |
| Applicant Address | 11th floor, Zhenqian Building, Yousong Community, Longhua Street,Longhua District Shenzhen 518110 China | |
| Applicant Contact Telephone | +86 13682320556 | |
| Applicant Contact | Mr. Xie Jie | |
| Applicant Contact Email | mdc-fs@foxmail.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | Transcutaneous Electrical Nerve Stimulator (K6106) | |
| Common Name | Transcutaneous electrical nerve stimulator for pain relief | |
| Classification Name | Stimulator, Nerve, Transcutaneous, Over-The-Counter | |
| Regulation Number | 882.5890 | |
| Product Code(s) | NUH, NGX |
Legally Marketed Predicate Devices
Predicate Trade Name (Primary Predicate is listed first) Predicate # Product Code K171803 HIVOX OTC Electrical Stimulator NUH HIVOX Spopad EMS K192264 NGX TENS & PMS K201354 NUH K191151 JKH Stimulator Plus NUH
Device Description Summary
Transcutaneous Electrical Nerve Stimulator is a portable and DC 3.7V battery powered multifunction device that adopts modern electronic science and technology to delivers electric pulses generated to the electrodes. It has two functions: Transcutaneous electrical nerve stimulation(TENS) and Electrical muscle stimulation (EMS).
The device has 20 operation programs. It includes operating elements of Power ON/OFF button, intensity decrease button, Menu selection button, and A/B channel selection button.
The display screen can show battery power, program, mode, keylock status, intensity level, treatment time and output channel. The device is equipped with accessories of electrode cables, and one Type-C cable. The electrode cables are used to connect the pads to the device; the Type-C cable is used to connect the charger and the built-in lithium battery.
In additional, according to different simulation-needed bodies, users can choose the three types of electrode pad based on their own situation. The electrode pads are manufactured by ShenZhen Technology Co., Ltd with 510(k) cleared Number K171381.
Intended Use/Indications 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 (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
21 CFR 807.92(a)(4)
21 CFR 807.92(a)(3)
21 CFR 807.92(a)(5)
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EMS: The device is designed to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Indications for Use Comparison
The subject device has the same indications for use as the predicate devices as below:
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 and facilitate muscle performance.
Technological Comparison
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
See Comparison Table on pg. 4 below.
Note 1
Dimension / Weight / Electrode area would be different device design in internal circuit and components choosing, which won't affect the safety and effectiveness, so it can deem as the substantially equivalence. The design of the intended use. For the subject device, the user could adjust the time based on user's included in predicate device. Note 2
The subject device has 20 output modes while the predicate devices have 50 or 15 output modes. All of the treatment programs of the subject device have passed the IEC 60601-2-10 and AAM / ANSI ES60601-1 test. So this difference doesn't raise any safety or effectiveness issue.
Note 3
Although the "Waveform", "Maximum Output Current" of the subject device are a little different from the predicate devices, the ranges are included in predicate device and they all comply with the requirements of IEC 60601-1 and IEC 60601-2-10 standard, as well as the Guidance for Powered Muscle Conditioning. So these differences will not raise any safety or effectiveness issue.
Note 4
Frequency and pulse width is the time parameter of the waveform. There is only little difference between the Frequency and Pulse width of the subject device, which is in the range of predicate devices comply with IEC 60601-1, and IEC60601-2-10, which means we have proved its safety as well as the effectiveness comparing with the predicate device and predicate device are substantially equivalence on these parameters.
Note 5
Although the "Maximum Phase Charge", "Maximum Current Density", "Maximum Average Current", and "Maximum Power Density" of the subject device is a little different from the predicate device in predicate device and they all comply with the requirements of IEC 60601-1 and IEC 60601-2-10 standard. Besides, the maximum power density meets with the maximum allowed value 0.25 (W/cm²) required in FDA guidance. Therefore, the subject device are substantially equivalence on these
් NoneElinical and/or Clinical Tests Summary & Conclusions
Non-Clinical Test Conclusion
The Transcutaneous Electrical Nerve Stimulator comply with the following Electrical & Thermal Safety, and Electromagnetic Compatibility standards:
-
IEC 60601-1:2005+A1:2012+A2:2020 Medical Electrical Equipment - Part 1: General Requirements for Safety
-
IEC 60601-2-10:2012+A1:2016, Medical electrical equipment - Part 2-10: Particular requirements for the saled muscle stimulators
3.IEC 60601-1-2:2014+A1:2020 , Medical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, 2007
- IEC 60601-11:2015 , Medical electrical equipments for basic safety and essential performancecollateral standard: requirements for medical electrical systems used in the home healthcare environment.
FDA software validation guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on: January 11, 2002".
Guidance Document for Powered Muscle Stimulator 510(k)s Document issued on: June 9, 1999
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Conclusions
The electrical safety, EMC, biocompatibility, software verification, and output specifications information provided is sufficient to demonstrate substantial equivalence to the Transcutaneous Electrical Nerve Stimulator, model: K6106 is nearly identical to the predicate devices, differences in their characteristics do not raise new questions regarding safety and effectiveness with identical indications for use and essentially identical technological characteristics, the Transcutaneous Electrical Nerve Stimulator, model: K6106 is substantially equivalent to the predicate devices.
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File No.: Substantial Equivalence Comparison
Substantial Equivalence Comparison
The technological characteristics, features, specifications, materials, and intended use of TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR is substantially equivalent to the predicate devices quoted below. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements ofComparison | Subject Device | Predicate Device (Primary) | Reference Device | Reference Device | Reference Device | Comparison |
|---|---|---|---|---|---|---|
| Manufacturer | Shenzhen Yicai HealthTechnology Co., Ltd. | HIVOX BIOTEK INC. | Hivox BiotekInc. | Hong Qiangxing(Shenzhen) ElectronicsLimited | JKH USA, LLC | -- |
| 510 (k) Number | - | K171803 | K192264 | K201354 | K191151 | -- |
| Product Name | Transcutaneous ElectricalNerve Stimulator | HIVOX OTC ElectricalStimulator | HIVOXSpopad EMS | TENS & PMS | JKH StimulatorPlus | -- |
| Models | K6106 | SEM44, SEM44-1, | SP-911, SP-921 | SM9196 | PL-029K5BL | -- |
| Product code | NUH, NGX | NUH, NGX | NGX | NUH, NGX | NUH, NGX, NYN,GZJ, IPF, IRT | Same |
| Regulation number | 21 CFR 882.589021 CFR 890.5850 | 21 CFR 882.589021 CFR 890.5850 | 21 CFR 890.5850 | 21 CFR 882.589021 CFR 890.5850 | 21 CFR 882.589021 CFR 890.5850 | Same |
| Prescription/ OTC | OTC | OTC | OTC | OTC | OTC | Same |
| File No.: | Substantial Equivalence Comparison | |||||
| Intended Use | TENS: The device isdesigned to be used fortemporary relief of painassociated with sore andaching muscles in theshoulder, waist, back,neck, upper extremities(arm), lower extremities(leg), abdomen andbottom due to strain fromexercise or normalhousehold work activities.EMS: The device isdesigned to be used tostimulate healthymuscles in order toimprove and facilitatemuscle performance. | SEM44 –TENS: The device isdesigned to be used fortemporary relief of painassociated with sore andaching muscles in the shoulder,waist, back, neck,upper extremities (arm), lowerextremities (leg),abdomen and bottom due tostrain from exercise or normalhousehold work activities.EMS: The device is designed tobe used for stimulate healthy | Indicated for theimprovement of muscletone and firmness, forstrengthening muscles inarms, abdomen, thighs,and buttocks areas.Not intended for use inanytherapy or for thetreatment of any medicalconditions or diseases. | TENS(10 | TENS: PL-029K5BL,PL-029K15, and PL-029I are used fortemporary relief ofpain associated withsore and achingmuscles in theshoulder, waist, back,arm, and leg, dueto strain from exerciseor normal householdand work activitiesPL-029K5BL, PL-029K15, and PL-029T are alsointended for | Same |
| muscles in order to improve andfacilitate muscle performance.SEM44-1 –TENS: The device is designedto be used for temporary reliefof pain associated with sore andaching muscles in the shoulder,waist, back, neck, upperextremities (arm), lowerextremities (leg), abdomen andbottom due to strain fromexercise or normal householdwork activities. | in order to improve andfacilitate muscleperformance. | symptomatic reliefand management ofchronic, intractablepain and relief of painassociated witharthritisThe device of PL-029K5BL and PL-029K15 may be usedduring sleep. Thedevice of PL-029K5BL and PL-029K15 labeled foruse only with its owncompatible electrodesPMSPL-029K5BL, PL-029K 15, and PL-029T are used tostimulate healthymuscles in order toimprove and facilitatemuscleperformance. To | ||||
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Subject Device:
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR , Model: K6106 Substantial Equivalence Comparison
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Sponsor: Shenzhen Yicai Health Technology Co., Ltd.
Subject Device:
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR , Model: K6106
| File No.: | Substantial Equivalence Comparison | ||
|---|---|---|---|
| be used for theimprovement ofmuscle tone andfirmness , and forstrengtheningmuscles in thearms abdomen ,legs , and buttocks. Not intended foruse in any therapyor for the treatmentof any medicalconditions fordiseasesPL-029K5BL , PL-029K15 and PL-029T are alsointended totemporarilyincrease localblood circulation inthe healthymuscles of lowerextremities |
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Subject Device: TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR , Model: K6106
File No.: Substantial Equivalence Comparison
| File No.. Substantial Equivalence Comparison | |||||||
|---|---|---|---|---|---|---|---|
| Power Supply | Internal battery: 3.7Vd.c.300mAh | 4.5V (batteries, 3x1.5VAAA) | 3 V battery × 1 | DC 3.7V lithium battery | Rechargeable ornon-rechargeablebattery | Same | |
| Method of Line CurrentIsolation | Type BF | N/A | Battery supply | Type BF | Battery Supply | Same | |
| Size (L x W x H) | 118mm x 65mm x 20mm | 132 x 63 x 29.5 mm (includingbelt clip) | 8.15 x 4.06 x0.51 inch | 180mm x 58mm x 15.5mm | PL-029K5BL:66x56x18mm | SimilarNote 1 | |
| Weight(g) | 110 g / 0.24 lb | 89 g (including belt clip, withoutbatteries), 123 g (including beltclip and batteries) | 24.2 g | 100g±5g | PL-029K5BL: 40g | SimilarNote 1 | |
| Patient LeakageCurrentNormal Condition(μΑ) | <1 µA | N/A | 2.0 μΑ | < 10μA | N/A | Same | |
| Patient LeakageCurrentSingle FaultCondition (μA) | <1 µA | N/A | 2.1 µA | <50 µA | N/A | Same | |
| Number of OutputModes | TENS mode: 10EMS mode: 10 | TENS mode: 15EMS mode: 35 | 1 | 15 | PL-029K5BL: 6-8 | SimilarNote 2 | |
| Number of outputchannels: | 4 | 2 | 1 | 4 | 1-2 | Same | |
| Synchronous orAlternating | Synchronous | Synchronous | Single channel | Synchronous & Alternating | N/A | Same | |
| Method of channelisolation | By electrical circuit andsoftware | By electrical circuit and software | Single channel | Voltage transformerIsolation | N/A | Same | |
| Regulated current orregulated voltage? | Regulated Voltage | Regulated Voltage | Regulated Voltage | Voltage control | Voltage | Same | |
| Software/Firmware/MicroprocessorControl? | Software | Software | Software | Software | Software | Same | |
| Automatic overloadtrip? | No | Yes | No | No | No | Same | |
| Automatic no-loadtrip? | No | Yes | No | No | Yes | Same | |
| Automatic shut-off? | Yes | Yes | Yes | Yes | Yes | Same | |
| User overridescontrol? | Yes | Yes | Yes | Yes | Yes | Same | |
| IndicatorDisplay | On/OffStatus | Yes | Yes | No | Yes | Yes | Same |
| LowBattery | Yes | Yes | No | Yes | Yes | Same | |
| Voltage/CurrentLevel | Yes | Yes | No | Yes | Yes | Same | |
| Timer range(minutes) | 10 - 60 minutes | 5-100 minutes | 20 | 60 minutes | PL-029K5BL: 10-540 | SimilarNote 1 | |
| Compliance withvoluntarystandards? | IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-10 | IEC 60601-1,IEC 60601-1-2ISO10993-5/10 | IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-10 | AAMI/ANSI ES60601-1,IEC 60601-1-2,IEC 62133,IEC 60601-1-11 | AAMI/ANSIES60601-1,IEC 60601-1-2,IEC 60601-2-10,ISO10993-5/10 | Same |
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Subject Device: TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR , Model: K6106
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Subject Device: TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR , Model: K6106
| File No.: Substantial Equivalence Comparison | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Compliance with 21CFR 898-7 | Yes | Yes | Yes | Yes | Yes | Same | Frequency (Hz) | 2-80 Hz | 1-150Hz | 3/4/5 HZ | 1.613-49.02Hz | PL-029K5BL:1~500 Hz | Note 4 | |
| Housing material andconstruction | ABS plastic | ABS plastic | Silicone | ABS | Silicone & ABS | Same | For interferential modesonly - Beat Frequency | N/A | N/A | Not publicly available | Not publicly available | Not publiclyavailable | Same | |
| Waveform (e.g.,pulsed monophasic,biphasic) | Biphasic | Biphasic | Symmetrical biphasic | Pulsed, symmetric,biphasic | Biphasic | Same | Formulti-programwaveformsonly – | N/A | N/A | Not publicly available | Not publicly available | Not publicly available | Not publiclyavailable | Same |
| Shape | Square | Square | Rectangular | Rectangle | Rectangular | Same | N/A | N/A | Not publicly available | Not publicly available | Not publicly available | Not publiclyavailable | Same | |
| Maximum outputvoltage(V, ±10%) at 500 Ω | 68 | 50 | 52 | 54V±20% @500Ω | PL-029K5BL:65±20% | Note 3 | Net charge per pulseat 500 Ω(μC) | 0μC @500Ω | 0.001μC@500Ω | 0.416 | 0μC @500Ω | Not publiclyavailable | Same | |
| Maximum outputvoltage(V, ±10%) at 2k Ω | 136 | 90 | 102 | 101 | PL-029K5BL:132±20% | Note 3 | Maximum Phasecharge at 500 Ω (μC) | 65.82 | 45 | 41.6 | 17 | PL-029K5BL: 78μC | Note 5 | |
| Maximum outputvoltage(V, ±10%) at 10k Ω | 208 | 125 | 150 | 133 | PL-029K5BL:180±20% | Note 3 | Maximum currentdensity at 500 Ω(mA/cm²) | 1.001 | 0.667 | 1.672 | 0.08mA/cm2 @500Ω | PL-029K5BL: 1.86 | Note 5 | |
| Maximum outputcurrent(mA, ±10%) at 500 Ω | 136 | 200 | 104 | 108mA±20% @500Ω | PL-029K5BL:130±20% | Note 3 | Max. Average current(average absolutevalue), mA | 24.33@500Ω | 13.5@500Ω | Not publicly available | 1.88 | Not publiclyavailable | Note 5 | |
| Maximum outputcurrent(mA, ±10%) at 2k Ω | 68 | 90 | 51 | 50.5 | PL-029K5BL:66±20% | Note 3 | Maximum averagepower density W/cm²at 500 Ω(usingsmallest electrodeconductive surfacearea) | 0.0122 | 0.0046@500Ω | 0.0869 W/cm² | 0.00365 | 0.028 | Note 5 | |
| Maximum outputcurrent(mA, ±10%) at 10k Ω | 20.8 | 25 | 15 | 13.3 | PL-029K5BL:18±20% | Note 3 | Burstmode | A.Pulseperburst | NA | 3 | N/A | Same | ||
| Duration of primaryphase | 120-400μS | 50-450µS | 0 | Not publicly available | 50~500µS | Note 4 | B. Burstpersecond | NA | 2/60Hz | N/A | Not publicly available | N/A | ||
| Pulse duration (μs) | 120-400μS | 50-450µS | 400μs | 200-210μs | 50~500µS | Note 4 |
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Subject Device: TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR , Model: K6106
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Subject Device: TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR , Model: K6106
File No.: Substantial Equivalence Comparison
| C. Burstduration(sec) | NA | 36ms | N/A | ||||
|---|---|---|---|---|---|---|---|
| D. Dutycycle | NA | 36ms/390ms | N/A | ||||
| ON Time (seconds) | 1s | 2s | Not publicly available | 3.1-20 | 1~20 | Same | |
| OFF Time(seconds) | 1s | 2s | Not publicly available | 1-3 | 0~10 | Same | |
| Electrode area | S(24.3cm²), M(40.8 cm²), L(67.71 cm²) | 20.25sqcm x4 (81sqcm) | 62.20 cm²(Two electrodes) | Not publicly available | Not publiclyavailable | Note 1 | |
| Average DCcurrent throughelectrodes whendevice is on but nopulses are beingapplied (µA) | 0 | 0 | Not publicly available | < 0.01μA | 0 | Same |
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Note 1
Dimension / Weight / Electrode area would be different device design in internal circuit and components choosing, which won't affect the safety and effectiveness, so it can deem as the substantially equivalence. The design of the timer range is based on the intended use. For the subject device, the user could adjust the time based on user's need, and the range is included in predicate device.
Note 2
The subject device has 20 output modes while the predicate devices have 50 or 15 output modes. All of the treatment programs of the subject device have passed the IEC 60601-2-10 and AAMI / ANSI ES60601-1 test. So this difference doesn't raise any safety or effectiveness issue.
Note 3
Although the "Waveform", "Maximum Output Voltage" and "Maximum Output Current" of the subject device are a little different from the predicate devices, the ranges are included in predicate device and they all comply with the requirements of IEC 60601-1 and IEC 60601-2-10 standard, as well as the Guidance for Powered Muscle Stimulator for Muscle Conditioning. So these differences will not raise any safety or effectiveness issue.
Note 4
Frequency and pulse width is the time parameter of the waveform. There is only little difference between the Frequency and Pulse width of the subject device, which is in the range of predicate device. As the subject devices comply with IEC 60601-1, and IEC60601-2-10, which means we have proved its safety as well as the effectiveness comparing with the predicate device. Therefore, the subject device and predicate device are substantially equivalence on these parameters.
Note 5
Although the "Maximum Phase Charge", "Maximum Current Density", "Maximum Average Current", and "Maximum Power Density" of the subject device is a little different from the predicate device, the ranges are included in predicate device and they all comply with the requirements of IEC 60601-1 and IEC 60601-2-10 standard. Besides, the maximum power density meets with the maximum allowed value 0.25 (W/cm²) required in FDA guidance. Therefore, the subject device and predicate device are substantially equivalence on these parameters.
Conclusion
Based on the performance testing, comparison and analysis, the subject device Transcutaneous Electrical Nerve Stimulator (Model: K6106) is substantially equivalent to the predicate device.
§ 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).