(88 days)
PMS (mode 1~3): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
TENS (mode 4-6): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Heating: This function is designed to be used for temporary relief of minor aches and pains.
Ems Foot Stimulator is a portable and adapter powered multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS), Powered Muscle Stimulator (PMS) and heating qualities.
Ems Foot Stimulator has 6 modes (PMS mode 13, TENS mode 46), which can give certain electrical pulse through 6 pcs of electrode Pad placed on the body to help users to enjoy body stimulation. There are 2 big electrode pads in foot conductive area for feet placed on the main unit to help users to enjoy sole stimulation. And a heating belt can provide heating treatment on waist area.
The main unit has the operating elements of Power on/off switch, ON/OFF Switch, Display screen, 2 Mode Selection keys, 2 Intensity Selection keys and a time setting key.
The LCD display screen can show selected mode, output intensity of body and sole, heating level and time remaining of an application mode.
The remote controller has a ON/OFF Switch to control the EMS/ TENS treatment, a ON/OFF switch to control heating treatment, 2 mode selection keys, 2 intensity selection keys, 2 heating adjust keys and a time setting key.
The heating belt and foot conductive pad can only warm the waist and foot rang 30 to 41 degree C The Heating adjust keys on remote controller can help user to adjust the temperature for warming the waist and foot simultaneously. The heating time is same as the treatment time you selected. The heating and stimulation can be applied simultaneously.
There are 4 models, model HK701, HK701A, and HK701C, all the four models include a main unit and many accessories. The main unit of the four models are the same, the difference is only the accessories included in the package, so the function is a little different.
This document is a 510(k) summary for the Ems Foot Stimulator, a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) device. The purpose of this summary is to demonstrate substantial equivalence to previously cleared devices, not to present a study proving the device meets a specific set of acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding acceptance criteria and a detailed study proving performance is not directly available in this type of submission.
Based on the provided text, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present specific acceptance criteria in a quantifiable table for clinical performance (e.g., sensitivity, specificity for a diagnostic device or a specific clinical outcome for a therapeutic device) nor does it report device performance against such criteria. Instead, it demonstrates substantial equivalence to predicate devices through technical comparisons and compliance with recognized standards.
The document lists performance characteristics for the subject device and predicate devices for comparison. These are not acceptance criteria in the sense of a clinical outcome, but rather technical specifications and safety parameters.
| Element of Comparison | Subject Device (Ems Foot Stimulator) | Primary Predicate Device (K203574) | Secondary Predicate Device (K190783) | Remark |
|---|---|---|---|---|
| Intended Use | PMS (stimulate healthy muscles), TENS (temporary pain relief), Heating (temporary minor aches/pains) | TENS (temporary pain relief), EMS (stimulate healthy muscles), SH (temporary minor aches/pains) | PMS (stimulate healthy muscles), TENS (temporary pain relief) | Same |
| Power Source | Adaptor Input: 100-240Vac, Output: DC12V-3A | Rechargeable battery | Adaptor Input: 100-240Vac, Output: 5Vdc, 2A | Similar (Note 1) |
| Function and Design | Electrical stimulation and heat | Electrical stimulation and heat | Electrical stimulation and heat | Same |
| Heating Setting | Adjustable | Low and high | Adjustable | Same |
| Output Patterns | Electrical stimulation only, Heat only, Electrical stimulation + heat simultaneously | Electrical stimulation only, Heat only, Electrical stimulation + heat simultaneously | Not public available | Same |
| Method of Line Current Isolation | Type BF Applied Part | N/A (internal power source) | Type BF Applied Part | Same |
| Patient Leakage Current (NC) | AC: 54.5μA, DC: 0.5μA | 6.0 μΑ | AC: 54.5μA, DC: 0.5μA | Same |
| Patient Leakage Current (SFC) | AC: 120.0μA, DC: 0.6μA | 5.6 μΑ | AC: 120.0μA, DC: 0.6μA | Same |
| Average DC current through electrodes (no pulses) | < 0.01μA | Not public available | < 0.01μA | Same |
| Number of Output Channel | 2 | 2 | 2 | Same |
| Number of Output Modes | 6 | Model EM 59-2: TENS: 15, EMS: 35 | 25 | Similar (Note 2) |
| Heating Temperature Range | 30-41°C | SH: 1, Max temp setting 43°C | 30-40°C | Similar (Note 2) |
| Output Intensity Level | TENS: 99 steps, EMS: 99 steps, Heating: 6 levels | TENS: 0 to 50, EMS: 0 to 50, SH: LOW to HI | 99 steps | Similar (Note 2) |
| Timer Range | 15min, 20min, 25min, 30min | 5 to 100 minutes adjustable | 25 to 60 min | Similar (Note 2) |
| Maximum Output Voltage @ 500Ω | 44V ± 10% | 50V ± 20% | 44V ± 10% | Same |
| Maximum Output Voltage @ 2KΩ | 80V ± 10% | 90V ± 20% | 80V ± 10% | Same |
| Maximum Output Voltage @ 10KΩ | 112V ± 10% | 125V ± 20% | 112V ± 10% | Same |
| Maximum Output Current @ 500Ω | 88mA ± 10% | 100mA ± 20% | 88mA ± 10% | Same |
| Maximum Output Current @ 2KΩ | 40mA ± 10% | 45mA ± 20% | 40mA ± 10% | Same |
| Maximum Output Current @ 10KΩ | 11.2mA ± 10% | 12.5mA ± 20% | 11.2mA ± 10% | Same |
| Pulse Duration | 120μs | 50 to 450 | 120μs | Same |
| Pulse frequency | 77.3Hz | 1 to 150 | 77.3Hz | Same |
| Net Charge (per pulse) @ 500Ω | 0µC | 0µC | 0µC | Same |
| Maximum Phase Charge @ 500Ω | 10.56μC | 45μC | 10.56μC | Same |
| Maximum Average Current @ 500Ω | 1.63mA | 13.5 mA | 1.63mA | Same |
| Maximum Current Density (r.m.s) @ 500Ω | 5.5 mA/cm2 | 0.667mA/cm2 | 0.0326 mA/cm2 | Different (Note 2) |
| Maximum Average Power Density @ 500Ω | 0.0000831mW/cm2 | 0.0046 W/cm2 | 0.0000266mW/cm2 | Different (Note 2) |
| Biocompatibility | Compliance with ISO10993-5 and ISO10993-10 requirements | ISO 10993-5, ISO 10993-10 | Compliance with ISO10993-5 and ISO10993-10 requirements | Same |
| Electrical Safety | IEC 60601-1, IEC 60601-2-10 | ES 60601-1, IEC 60601-2-10 | Comply with IEC 60601-1 and IEC 60601-2-10 | Same |
| EMC | 60601-1-2 | IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same |
Note 1: The power source difference from predicate devices is addressed by compliance with IEC 60601-1, asserting no safety/effectiveness issue.
Note 2: Differences in "number of output modes," "heating temperature," "output intensity level," "timer range," "maximum current density," and "maximum average power density" are addressed by passing safety tests complying with FDA-recognized consensus standards, asserting no adverse impact on safety/effectiveness.
2. Sample size used for the test set and the data provenance
The document explicitly states: "No clinical study was performed." (page 6). Therefore, there is no test set or clinical data provenance in the context of a clinical trial for device efficacy. Performance data provided are from non-clinical tests (biocompatibility, electrical safety, EMC, usability, software V&V). These tests were likely conducted on a representative sample of the manufactured device. Specific sample sizes for these engineering tests are not provided in this summary. The data provenance for non-clinical tests is generally from internal testing or certified external labs.
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 study was performed and thus no "ground truth" was established based on expert assessment for a clinical test set.
4. Adjudication method for the test set
Not applicable, as no clinical study was performed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study was performed."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This device is a physical medical device (TENS/PMS unit), not an algorithm or AI. Standalone performance as typically described for AI/software devices is not applicable. The performance demonstrated is through non-clinical bench testing and compliance with electrical, safety, and biocompatibility standards.
7. The type of ground truth used
For the non-clinical tests performed:
- Biocompatibility: Ground truth is established by standards like ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), where the "truth" is whether the materials elicit an adverse biological response.
- Electrical safety and EMC: Ground truth is established by compliance with international standards such as IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10, and IEC 60601-1-2.
- Usability Testing: Ground truth is established by compliance with standards like IEC 62366-1 and IEC 60601-1-6.
- Software Verification and Validation Testing: Ground truth is established by FDA's guidance for software in medical devices, assuring that the software functions as intended and does not lead to minor injury.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device that requires a training set and ground truth for training.
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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 29, 2022
Guangzhou Hua Kai Electronic Technology Co., Ltd. % Cassie Lee Official Correspondent 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, Guangdong 510000 China
Re: K221251
Trade/Device Name: Ems Foot Stimulator (model: HK701A, HK701A, HK701B, HK701C) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX, IRT Dated: April 21, 2022 Received: May 2, 2022
Dear Cassie Lee:
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.
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
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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,
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
510(k) Number (if known) K220251
Device Name
Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)
Indications for Use (Describe)
PMS (mode 1~3): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
TENS (mode 4-6): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Heating: This function is designed to be used for temporary relief of minor aches and pains.
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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Chapter 6. 510(k) Summary
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.
Submitter's Information 1.
Name: Guangzhou Hua Kai Electronic Technology Co., Ltd. Address: 4th Floor, Building 8, No.39 Bi Gang Road, Donggu Street, Huangpu District Guangzhou, Guangdong, 510730, CHINA Contact name: Cao Ke Title: Manager Tel: +86-020-82061985 E-mail: 252288906@qq.com Email: annaosto@163.com
Application Correspondent: 2.
Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com
Subject Device Information 3.
Common Name: Transcutaneous electrical nerve stimulator for pain relief Trade Name: Ems Foot Stimulator Classification Name: Stimulator, Nerve, Transcutaneous, Over-the-Counter Model: HK-701, HK-701A, HK-701B, HK-701C Regulatory Class: II Product Code: NUH, NGX, IRT Regulation Number: 882.5890, 890.5850, 890.5740
2. Predicate Device Information
Predicate Device 1:
510(K) Number: K203574
Report by
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Company Name: HIVOX BIOTEK INC.
Address: 5F., No. 123, Xingde Rd., Sanchong Dist., New Taipei City 24158, Taiwan, R.O.C.
Trade Name: Health Expert Electronic Stimulator
Model: EM59-1, EM59-2
Requlation Number: 882.5890, 890.5850, 890.5740
Requlatory Class: II
Product Code: NUH, NGX, IRT
Predicate Device 2:
510(K) Number: K190783 Company Name: Shenzhen OSTO Technology Company Limited Address: No.43 Longfeng Road, Xinsheng Community, Longgang Street, Longgang District, Shenzhen City, Guangdong Province, China Trade Name: Health Expert Electronic Stimulator Model: AST-300L Common Name: Electronic Stimulator Regulation Number: 882.5890 Requlatory Class: II Product Code: NUH, NGX
3. Device Description
Ems Foot Stimulator is a portable and adapter powered multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS), Powered Muscle Stimulator (PMS) and heating qualities.
Ems Foot Stimulator has 6 modes (PMS mode 13, TENS mode 46), which can give certain electrical pulse through 6 pcs of electrode Pad placed on the body to help users to enjoy body stimulation. There are 2 big electrode pads in foot conductive area for feet placed on the main unit to help users to enjoy sole stimulation. And a heating belt can provide heating treatment on waist area.
The main unit has the operating elements of Power on/off switch, ON/OFF Switch, Display screen, 2 Mode Selection keys, 2 Intensity Selection keys and a time setting key.
The LCD display screen can show selected mode, output intensity of body and sole, heating level and time remaining of an application mode.
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| Sponsor: | Guangzhou Hua Kai Electronic Technology Co., Ltd. |
|---|---|
| Subject Device: | EMS Foot Massager |
| File No.: | 510(k) submission report (V1.0) |
The remote controller has a ON/OFF Switch to control the EMS/ TENS treatment, a ON/OFF switch to control heating treatment, 2 mode selection keys, 2 intensity selection keys, 2 heating adjust keys and a time setting key.
The heating belt and foot conductive pad can only warm the waist and foot rang 30 to 41 ˚C The Heating adjust keys on remote controller can help user to adjust the temperature for warming the waist and foot simultaneously. The heating time is same as the treatment time you selected. The heating and stimulation can be applied simultaneously.
There are 4 models, model HK701, HK701A, and HK701C, all the four models include a main unit and many accessories. The main unit of the four models are the same, the difference is only the accessories included in the package, so the function is a little different. Model difference is as below:
| Item | HK701 | HK701A | HK701B | HK701C |
|---|---|---|---|---|
| Function | Stimulation onfoot and body,heating on footand waist. | Stimulation onfoot, heating onfoot. | Stimulation onfoot, heating onwaist. | Stimulation onfoot and body,heating on foot. |
| Accessories. | 3 pairs ofelectrode pads,a heating belt,an adapter, 2electrode wire,a remotecontroller. | An adapter, aremotecontroller. | A heating belt,an adapter,a remotecontroller. | 3 pairs ofelectrode pads,an adapter, 2electrode wire, aremote controller. |
4. Intended Use / Indications for Use
PMS (mode 1~3): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
TENS (mode 4~6): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve. Heating: This function is designed to be used for temporary relief of minor aches and pains.
5. Performance data and test summary
The following performance data were provided in support of the substantial equivalence determination.
Nonclinical test performed
- Biocompatibility testing
The biocompatibility evaluation for the Ems Foot Stimulator was conducted in accordance with "Use of International SO 10993-1, "Biological evaluation of medical devices -
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| Sponsor: | Guangzhou Hua Kai Electronic Technology Co., Ltd. |
|---|---|
| Subject Device: | EMS Foot Massager |
| File No.: | 510(k) submission report (V1.0) |
Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatibility testing included the following tests:
- . Cytotoxicity
- . Sensitization
- Irritation .
According to the test results, the subject device is biocompatible for its intended use. And it is complied with biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 Irritation and Sensitization).
- Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Ems Foot Stimulator, the device complies with the IEC 60601-1, IEC 60601-1-11, and IEC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC.
- Usability Testing
Usability testing were conducted on the Ems Foot Stimulator, the device complies with IEC 62366-1 and IEC 60601-1-6.
- 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, since a malfunction of, or a latent design flaw in, the Software Device lead s to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.
Clinical performance testing performed
No clinical study was performed.
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6. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, mode of operation, and intended use of Ems Foot Stimulator is substantially equivalent to the predicate devices quoted above.
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
Comparison in Detail(s):
| Elements ofComparison | Subject Device | Primary PredicateDevice | SecondaryPredicateDevice | Remark | |
|---|---|---|---|---|---|
| Device Nameand Model | Ems Foot StimulatorModel: 701, 701A,701B, 701C | HIVOX OTC ElectricalStimulatorModel: EM59-1, EM59-2 | Health ExpertElectronicStimulatorModel: AST-300L | -- | |
| 510(k) Number | Applying | K203574 | K190783 | -- | |
| Product Code | NUH, NGX, IRT | NUH, NGX, IRT | NUH, NGX | Same | |
| Intended Use | PMS (mode 1 | HIVOX OTC ElectricalStimulator, EM59-2TENS: This function isdesignated to be used fortemporary relief of painassociated with sore andaching muscles in theshoulder, waist, back,upper extremities (arm)and lower extremities (leg)due to strain fromexercise or normalhouseholdwork activities.EMS: This function isdesigned to be used forstimulating healthymuscles in order toimprove and facilitatemuscleperformance.SH: This function isdesigned to be used fortemporary relief of minoraches and pains. | PMS (Mode 1 | Same | |
| Elements ofComparison | Subject Device | Primary PredicateDevice | SecondaryPredicateDevice | Remark | |
| PowerSource(s) | Adaptor Input: 100-240Vac, 50-60Hz,0.1AOutput: DC12V-3A | Rechargeable battery | Adaptor Input:100-240Vac, 50-60Hz,0.1AOutput: 5Vdc, 2AUnit Input: 5Vdc, 2A | SimilarNote 1 | |
| Function andDesign | Electrical stimulationand heat | Electrical stimulation andheat | Electricalstimulation and heat | Same | |
| Heating Setting | Adjustable | Low and high | Adjustable | Same | |
| Output Patterns | ● Electricalstimulation only● Heat only● Electricalstimulation + heatsimultaneously | ● Electrical stimulationonly● Heat only● Electrical stimulation+ heatsimultaneously | Not public available | Same | |
| Method of LineCurrentIsolation | Type BF Applied Part | N/A (internal powersource) | Type BF AppliedPart | Same | |
| PatientLeakageCurrent | NCSFC | AC: 54.5μA, DC:0.5μAAC:120.0μA, DC:0.6μA | 6.0 μΑ5.6 μΑ | AC: 54.5μA, DC:0.5μAAC:120.0μA, DC:0.6μA | Same |
| Average DCcurrent throughelectrodes whendevice is on butno pulses arebeing applied | < 0.01μA | Not public available | < 0.01μA | Same | |
| Number ofOutput Channel | 2 | 2 | 2 | Same | |
| Number ofOutput Modes | 6 | Model EM 59-2:TENS: 15EMS: 35 | 25 | SimilarNote 2 | |
| Elements ofComparison | Subject Device | Primary PredicateDevice | SecondaryPredicateDevice | Remark | |
| 30-41°C | SH: 1Maximum temperaturesetting 43°C | 30-40°C | SimilarNote 2 | ||
| Output IntensityLevel | TENS: 99 stepsEMS: 99 stepsHeating: 6 levels | TENS: level 0 to 50EMS: Level 0 to 50SH: Level LOW to HI | 99 steps | SimilarNote 2 | |
| Synchronous orAlternating? | Synchronous | Synchronous | Synchronous | Same | |
| Method ofChannelIsolation | By electrical circuit andsoftware | By electrical circuit andsoftware | Voltage TransformIsolation"Body+" and "Body-"buttons for bodychannel, "Sole+"and "Sole-" buttonsfor feet channel | Same | |
| RegulatedCurrent orRegulatedVoltage? | Voltage Control | Regulated current | Voltage Control | Same | |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Yes | Same | |
| AutomaticOverload Trip | No | Yes | No | Same | |
| Automatic No-Load Trip | No | Yes | No | Same | |
| Automatic ShutOff | Yes | Yes | Yes | Same | |
| User OverrideControl | Yes | Yes | Yes | Same | |
| IndicatorDisplay | On/OffStatus | Yes | Yes | Yes | Same |
| LowBattery | No | Yes | No | Same | |
| Elements ofComparison | Subject Device | Primary PredicateDevice | SecondaryPredicateDevice | Remark | |
| Voltage/Current Level | Yes | Yes | Yes | Same | |
| Timer Range | 15min, 20min, 25min,30min | 5 to 100 minutesadjustable | 25 to 60 min | SimilarNote 2 | |
| Weight | 2.28Kg (Withoutaccessories) | Approx. 125 (includingbelt clip and battery) | 2.1Kg (Withoutaccessories) | DifferentNote 3 | |
| Dimensions | 41 x 40 x 13cm | Approx. 139 x 66 x26(including belt clip) | 429.2mm x 401mmx 152.8mm | DifferentNote 3 | |
| HousingMaterials andConstruction | Main unit: ABS plastic | Plastic (ABS) enclosure | Main unit: ABSplastic | Same | |
| Waveform | Pulsed, symmetric,biphasic | Biphasic | Pulsed, symmetric,biphasic | Same | |
| Shape | Rectangular, withinterphase interval | Rectangular | Rectangular, withinterphase interval | Same | |
| MaximumOutput Voltage | $44V±10% @ 500Ω$ | $50V±20% @ 500Ω$ | $44V±10% @ 500Ω$ | Same | |
| $80V±10% @ 2KΩ$ | $90V±20% @ 2KΩ$ | $80V±10% @ 2KΩ$ | |||
| $112V±10% @ 10KΩ$ | $125V±20% @ 10KΩ$ | $112V±10% @ 10KΩ$ | |||
| MaximumOutput Current | $88mA±10% @ 500Ω$ | $100mA±20% @ 500Ω$ | $88mA±10% @ 500Ω$ | Same | |
| $40mA±10% @ 2KΩ$ | $45mA±20% @ 2KΩ$ | $40mA±10% @ 2KΩ$ | |||
| $11.2mA±10% @ 10KΩ$ | $12.5mA±20% @ 10KΩ$ | $11.2mA±10% @ 10KΩ$ | |||
| Pulse Duration | $120μs$ | 50 to 450 | $120μs$ | Same | |
| Pulse frequency | 77.3Hz | 1 to 150 | 77.3Hz | Same | |
| Net Charge (perpulse) | $0µC @ 500Ω$ | $0µC @ 500Ω$ | $0µC @ 500Ω$Method: Balancedwaveform | Same | |
| Elements ofComparison | Subject Device | Primary PredicateDevice | SecondaryPredicateDevice | Remark | |
| MaximumPhase Charge | 10.56μC @ 500Ω | 45μC @ 500Ω | 10.56μC @ 500Ω | Same | |
| MaximumAverageCurrent | 1.63mA @ 500Ω | 13.5 mA @ 500Ω | 1.63mA @ 500Ω | Same | |
| MaximumCurrent Density(r.m.s) | 5.5 mA/cm2 @ 500Ω | 0.667mA/cm2 @500Ω | 0.0326 mA/cm2 @500Ω | DifferentNote 2 | |
| MaximumAverage PowerDensity | 0.0000831mW/cm2 @500Ω | 0.0046 W/cm2@500Ω | 0.0000266mW/cm2@ 500Ω | DifferentNote 2 | |
| Environment foroperating | Temperature: 5 ~ 45° CHumidity: 20 ~ 65%RH | Temperature: 5~40° CHumidity: 15% RH to 90%RH | Temperature: 5 ~45° CHumidity: 20 ~ 65%RH | Same | |
| Environment forstorage | Temperature: 0 | Temperature: 0~40° CHumidity: 0% RH to 90%RH | Temperature: 0 | Same | |
| Biocompatibility | All user directlycontacting materialsare compliance withISO10993-5 andISO10993-10requirements. | ISO 10993-5ISO 10993-10 | All user directlycontacting materialsare compliance withISO10993-5 andISO10993-10requirements. | Same | |
| Electrical Safety | IEC 60601-1IEC 60601-2-10 | ES 60601-1IEC 60601-2-10 | Comply with IEC60601-1 and IEC60601-2-10 | Same | |
| EMC | 60601-1-2 | IEC 60601-1-2 | Comply with IEC60601-1-2 | Same |
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Guangzhou Hua Kai Electronic Technology Co., Ltd. Sponsor: Subject Device: EMS Foot Stimulator File No.: 510(k) submission report (V1.0)
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Guangzhou Hua Kai Electronic Technology Co., Ltd. Sponsor: Subject Device: EMS Foot Stimulator File No.: 510(k) submission report (V1.0)
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Guangzhou Hua Kai Electronic Technology Co., Ltd. Sponsor: Subject Device: EMS Foot Stimulator File No.: 510(k) submission report (V1.0)
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Sponsor: Guangzhou Hua Kai Electronic Technology Co., Ltd. EMS Foot Stimulator Subject Device: File No.: 510(k) submission report (V1.0)
Comparison in Detail(s):
Note 1:
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| Sponsor: | Guangzhou Hua Kai Electronic Technology Co., Ltd |
|---|---|
| Subject Device: | EMS Foot Stimulator |
| File No.: | 510(k) submission report (V1.0) |
Although the "Power Source" is little different from the predicate devices, but it is complying with the IEC 60601-1 requirements. Therefore, the difference will not raise any safety or effectiveness issue.
Note 2:
Although the "number of output modes", "heating temperature", "output intensity level", "timer range", "maximum current density", and "maximum average power density" are a little different from the predicate devices, the subject devices have undergone and passed a series of safety tests complied with the specified FDA-recognized consensus standards to demonstrate these differences would not adversely impact the safety and effectiveness of the subject device. The differences will not raise any safety or effectiveness issue.
Note 3:
Although the "weight" and "dimension" are alittle different from the predicate devices, but the difference with not raise safety or effectiveness issue.
Finial Conclusion:
The subject device is as safe, as effective, and performs as well as the legally marketed predicated devices K203574 and K190378.
- Date of the summary prepared: April 20, 2022
§ 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).