(175 days)
Models: uLumb-9530A、uLumb-9531A、uLumb-9532A、uLumb-9533A、LQ-9525B:
Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of neck, arm, and leg, due to strain from exercise or normal household and work activities.
Notel : The electrode on the stimulator is used in the waist.
Note2: The additional gel patch is used in shoulder, waist, back, back of neck, arm, and leg,
Heating: To be used for temporary relief of minor aches and pains.
Models: uNeck-9512A, uNeck-9517B, uNeck-9517B, uNeck-9519A, uNeck-9521A, uNeck-9529A, LO-9535 A: Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities. Heating: To be used for temporary relief of minor aches and pains.
The Electronic Stimulator is a portable and battery-powered TENS device with multiple models, offering both electrical pulse stimulation and heating function in one device.
The device consists of a controller that has built-in metal electrodes and accessories of a remote control, an adapter, and/or a pair of gel electrodes, an external connection coupling. The external connection coupling is used to connect the gel electrodes to the device. All models are powered by internal rechargeable battery and charged by the adapter. And all accessories, including the remote control, adapter, gel electrodes, external connection coupling can only be changed or replaced by a qualified person.
The functions of the device are controlled by the device controller and the remote control, where the remote control establishes a connection with the device controller through wireless signals. The device has five stimulation modes and one heating mode, through the metal electrodes to provide users with waist or nape stimulation and heat generation to warm and comfortable waist or nape muscles. And the heating function is controlled by a heat/temperature key and can only be run on metal electrodes, it is cannot be operated alone. The heating temperature does not exceed 43 degrees Celsius at the same time. In addition, the device is also equipped with a pair of gel electrodes, which can be used to stimulate different parts of the body (shoulder, waist, back, back of neck (nape), arm, and leg).
The device has 13 models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A, the 13 models differ in appearance, size, battery capacity, number of keys on the stimulator, the specification of electrodes equipped, and some output parameters, the details can refer to the "Model list form" of the Device Description file in this application.
This submission is for an Electronic Stimulator with multiple models, intended for temporary relief of pain associated with sore and aching muscles and temporary relief of minor aches and pains through electrical stimulation and heating.
The acceptance criteria and device performance are described below based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is not an AI/ML device but rather a Transcutaneous Electrical Nerve Stimulator (TENS), the "acceptance criteria" are compliance with established safety and performance standards for similar devices. The "reported device performance" refers to the successful completion or compliance with these standards and tests. No specific accuracy or diagnostic performance metrics typically associated with AI/ML devices are present.
| Acceptance Criteria (Standards & Tests Met) | Reported Device Performance |
|---|---|
| Biocompatibility Safety: | The materials of the patient-directly contacting components of the Electronic Stimulator were evaluated and passed biocompatibility testing. This included: |
| * ISO 10993-5 Biological Evaluation of Medical Devices -Part 5: Tests for In Vitro Cytotoxicity | * Passed ISO 10993-5 (In Vitro Cytotoxicity) |
| * ISO 10993-10 Biological Evaluation of Medical Devices –Part 10: Tests for Irritation and Skin Sensitization | * Passed ISO 10993-10 (Irritation and Skin Sensitization) |
| EMC and Electrical Safety: | Electrical safety and Eye safety testing was performed to and passed the following standards: |
| * IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance –Collateral standard: electromagnetic compatibility | * Passed IEC 60601-1-2 (EMC) |
| * IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance | * Passed IEC 60601-1 (General Safety and Essential Performance) |
| * IEC 60601-1-11 Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment | * Passed IEC 60601-1-11 (Home Healthcare Environment Safety) |
| * IEC 60601-2-10 Medical electrical equipment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators | * Passed IEC 60601-2-10 (Nerve and Muscle Stimulators Specific Requirements) |
| Software Verification and Validation: | Software documentation consistent with a moderate level of concern was submitted. System validation testing demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. |
| Other Performance Verification: | |
| * Electrodes performance test to verify current dispersion and shelf-life according to FDA Guidance -Shelf Life of Medical Device and ASTM F1980-07 Standard. | * Electrodes performance test was conducted to verify current dispersion and shelf-life, and it passed. |
| * Waveform and output test according to FDA Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning. | * Waveform and output test was conducted to verify output specifications, and it passed. The maximum output voltage, current, pulse duration, and frequency are within acceptable ranges for TENS devices, and the net charge per pulse is 0µC, achieved through a balanced waveform. Maximum temperature setting is 43°C, which is within the acceptable range for heating functions in similar devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical trials or AI/ML model evaluation with patient data. Instead, performance data is based on non-clinical testing of the device itself against established safety and performance standards. Therefore, information about sample size for a test set, data provenance (country of origin, retrospective/prospective), number of experts, or adjudication methods is not applicable in the context of this 510(k) summary for a TENS device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as this is a traditional medical device submission based on non-clinical engineering and safety performance, not an AI/ML device relying on expert-annotated ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable for the same reasons as above.
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 is not an AI-assisted device, and no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-based algorithm; it is a physical electrostimulation device with heating functions.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For this traditional medical device, "ground truth" refers to compliance with recognized consensus standards and predetermined engineering specifications for safety and effectiveness. This is demonstrated through objective physical and electrical testing, biocompatibility assessment, and software verification, rather than clinical outcomes or expert consensus on diagnostic images.
8. The Sample Size for the Training Set
Not applicable. This device does not employ machine learning or an AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 8, 2023
Shenzhen Leqing Medical Instrument Co., Ltd % Rain Yip Registration engineer Feiying Drug & Medical Consulting Technical Service Group Rm2401, ZhenYe International Center, No.3101-90 Qianhai Road Nanshan District Shenzhen, Guangdong 518000 China
Re: K223428
Trade/Device Name: Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A. LO-9525B. uNeck-9512A. uNeck-9515A. uNeck-9517B. uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, IRT Dated: January 17, 2023 Received: April 12, 2023
Dear Rain Yip:
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.
{1}------------------------------------------------
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).
Sincerelv.
Amber T. Ballard -S
Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K223428
Device Name
Electronic Stimulator (Models: uLumb-9530A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A)
Indications for Use (Describe)
Models: uLumb-9530A、uLumb-9531A、uLumb-9532A、uLumb-9533A、LQ-9525B:
Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of neck, arm, and leg, due to strain from exercise or normal household and work activities.
Notel : The electrode on the stimulator is used in the waist.
Note2: The additional gel patch is used in shoulder, waist, back, back of neck, arm, and leg,
Heating: To be used for temporary relief of minor aches and pains.
Models: uNeck-9512A, uNeck-9517B, uNeck-9517B, uNeck-9519A, uNeck-9521A, uNeck-9529A, LO-9535 A: Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities. Heating: 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary
"510(k) Summary" as required by 21 CFR Part 807.92.
Date: May 8, 2023
I. Submitter
Shenzhen Leqing Medical Instrument Co.,LTD 2-3/F, Building D, No.31 Fangkeng Road, Longgang, Shenzhen, Guangdong, China Post code: 518000 Tel .: +86 755 2839 2373
Shaodong Wang Management Representative Tel: +86 135 9035 9865 Email: wangsd@pentasmart.com.cn
II. Device
Trade Name: Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9517B, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck- 9529A, LQ-9535A) Common Name: Transcutaneous electrical nerve stimulator Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter Regulatory Class: II Product Code: NUH. IRT Regulation Number: 21 CFR 882.5890
III. Predicate Device
Primary Predicate device: 510(k) number: K211942 Manufacturer: Shenzhen OSTO Technology Company Limited Trade name: Heating Lumbar Therapy Cushion/AST-622 Product code: NGX, NUH, IRT Approval date: December 13, 2021
Secondary predicate device: 510(k) number: K190783 Manufacturer: Shenzhen OSTO Technology Company Limited Trade name: Health Expert Electronic Stimulator/AST-300L Product code: NUH, NGX Approval date: March 14, 2020
{4}------------------------------------------------
IV. Device Description
The Electronic Stimulator is a portable and battery-powered TENS device with multiple models, offering both electrical pulse stimulation and heating function in one device.
The device consists of a controller that has built-in metal electrodes and accessories of a remote control, an adapter, and/or a pair of gel electrodes, an external connection coupling. The external connection coupling is used to connect the gel electrodes to the device. All models are powered by internal rechargeable battery and charged by the adapter. And all accessories, including the remote control, adapter, gel electrodes, external connection coupling can only be changed or replaced by a qualified person.
The functions of the device are controlled by the device controller and the remote control, where the remote control establishes a connection with the device controller through wireless signals. The device has five stimulation modes and one heating mode, through the metal electrodes to provide users with waist or nape stimulation and heat generation to warm and comfortable waist or nape muscles. And the heating function is controlled by a heat/temperature key and can only be run on metal electrodes, it is cannot be operated alone. The heating temperature does not exceed 43 degrees Celsius at the same time. In addition, the device is also equipped with a pair of gel electrodes, which can be used to stimulate different parts of the body (shoulder, waist, back, back of neck (nape), arm, and leg).
The device has 13 models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A, the 13 models differ in appearance, size, battery capacity, number of keys on the stimulator, the specification of electrodes equipped, and some output parameters, the details can refer to the "Model list form" of the Device Description file in this application.
V. Indications for Use
Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B: Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of neck, arm, and leg, due to strain from exercise or normal household and work activities.
Note1: The electrode on the stimulator is used in the waist.
Note2: The additional gel patch is used in shoulder, waist, back, back of neck, arm, and leg. Heating: To be used for temporary relief of minor aches and pains.
Model): uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A:
Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities. Heating: To be used for temporary relief of minor aches and pains.
VI. Comparison of Technological Characteristics With the Predicate Device
{5}------------------------------------------------
Compare with predicate devices, the Electronic Stimulator is very similar in the same technical characteristics, features, specifications, materials, mode of operation, intended use, and the applicable standards. The differences between subject device and the predicate devices do not raise new questions of safety or effectiveness.
{6}------------------------------------------------
| Comparison items | Subject device | Secondary Predicate devices | Primary predicate device | ||
|---|---|---|---|---|---|
| 510(k) number | Pending | K190783 | K211942 | ||
| Device name | Electronic Stimulator | Health Expert Electronic Stimulator | Heating Lumbar Therapy Cushion | ||
| Model(s) | uLumb-9530A,uLumb-9531A,uLumb-9532A,uLumb-9533A, LQ-9525B | uNeck-9512A,uNeck-9515A,uNeck-9517B,uNeck-9518A,uNeck-9519A,uNeck-9521A,uNeck-9529A, LQ-9535A | AST-300L | AST-622 | |
| Manufacturer | Shenzhen Leqing Co.,LTD | Medical Instrument | Shenzhen OSTO Technology Company Limited | Shenzhen OSTO Technology Company Limited | |
| Indication foruse/Intended use | Electrical simulation:To be used fortemporary relief ofpain associated withsore and achingmuscles in theshoulder, waist, back,back of neck, arm, andleg, due to strain fromexercise or normalhousehold and workactivities.Notel: The electrodeon the stimulator isused in the waist.Note2: The additionalgel patch is used inshoulder, waist, back,back of neck, arm | Electrical simulation:To be usedfortemporary relief ofpain associated withsore and achingmuscles in the back ofneck, due to strainfrom exercise ornormal household andwork activities.Heating: To be usedfor temporary relief ofminor aches andpains. | PMS (Mode 1 | PMS(1 ~ 2): It is intended to stimulatehealthy muscles in order to improve andfacilitate muscle performance.TENS(3 ~ 5): To be used for temporaryrelief of pain associated with sore andaching muscles in the shoulder, waist,back, arm and leg due to strain fromexercise or normal household workactivities by applying current tostimulate nerve.Heating: The Heating Lumbar TherapyCushion is intended for temporary reliefof minor aches and pains. | |
| Comparison items | Subject device | Secondary Predicate devices | Primary predicate device | ||
| and leg.Heating: To be usedfor temporary relief ofminor aches andpains. | |||||
| Location for use | OTC | OTC | OTC | ||
| Power source(s) | Powered by theinternal rechargeablebattery, 7.4Vd.c.,2600mAh | Powered by theinternal rechargeablebattery, 3.7Vd.c.,700mAh (uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A)Powered by theinternal rechargeablebattery, 3.7Vd.c.,$280mAh*2$ (uNeck-9521A)Powered by theinternal rechargeablebattery, 3.7Vd.c.,1200mAh (uNeck-9529A, LQ-9535A) | Adaptor Input: 100-240Vac, 50-60Hz,0.1A, Output: 5Vdc, 2AUnit Input: 5Vdc, 2A | Power by adapter, 100-240VAC, 50-60Hz, Output: 5Vdc, 2AUnit Input: 5Vdc, 2A | |
| Charged by theexternal adapter: | Charged by theexternal adapter: | ||||
| Comparison items | Subject device | Secondary Predicate devices | Primary predicate device | ||
| Input: 100-240Va.c.,50/60Hz, 0.4A Max.Output: 5.0Vd.c.,2.0A | Input: 100-240Va.c.,50/60Hz, 0.4A Max.Output: 5.0Vd.c.,1.0A | ||||
| -Method of LineCurrent Isolation | Not applicable | Type BF Applied Part | Type BF Applied Part | ||
| -PatientLeakageCurrent | NC(μA) | <50μA | AC: 54.5μADC: 0.5μA | AC: 54.5μADC: 0μA | |
| SFC(μA) | <100μA | AC: 120μADC: 0.6μA | AC: 13.4μADC: 0μA | ||
| Average DC currentthrough electrodeswhen device is on butno pulses arebeing applied (μA) | 0μA | <0.01μA | Not publicly available | ||
| Function and design | Electrical stimulation and heat | Electrical stimulation and heat | Electrical stimulation and heat | ||
| Function outputpatterns | Electrical stimulation onlyElectrical stimulation + Heat simultaneously | Electrical stimulation onlyAlternating combinations of Electricalstimulation and Heat | Electrical stimulation onlyHeat onlyElectrical stimulation + Heatsimultaneously | ||
| Heating setting | (+/-2°C)Level LOW: 39°CLevel HIGH: 41°C | (+/-2°C)Level LOW: 39°CLevel HIGH: 41°C | AdjustableHeating temperature is from 30~40℃ | Level 1: 37°CLevel 2: 41°CLevel 3: 43°C | |
| Maximumtemperature setting | 43°C | 40°C | 43°C | ||
| Number of OutputModes | Electrical simulation: 5 modesHeat: 1 mode | 25 modes | For stimulation: 5 modesFor heating: 1 mode | ||
| Number of OutputLevels | Electrical simulation:60 levelsHeat: 2 levels | Electrical simulation:30 levelsHeat: 2 levels | 99 levels | For stimulation: 50 levelsFor heating: 3 levels | |
| Number of Output | 2 channels | 1 channel | 2 channels | 1 channel | |
| Comparison items | Subject device | Secondary Predicate devices | Primary predicate device | ||
| Channels | |||||
| Numberof OutputChannels | Synchronous orAlternating? | Alternating | Synchronous | Synchronous | |
| Method ofChannelIsolation | Potential transformer,RELAY, Softwareisolation | Voltage TransformIsolation"Body+" and "Body-" buttons forbody channel, "Sole+" and "Sole-"buttons for feet channel | Not applicable | ||
| Regulated Current orRegulated Voltage? | Regulated Voltage | Voltage Control | Regulated Voltage | ||
| Software/Firmware/MicroprocessorControl? | Yes | Yes | Yes | ||
| Automatic OverloadTrip? | No | No | No | ||
| Automatic No-LoadTrip? | No | No | No | ||
| Automatic Shut Off? | Yes | Yes | Yes | ||
| UserControl? | Override | No | Yes | Yes | |
| On/OffStatus? | Yes | Yes | Yes | ||
| IndicatorDisplay | LowBattery? | Yes | No | No | |
| Voltage/CurrentLevel? | Yes | Yes | Yes | ||
| Timer Range | Default 30 minutes.Adjustable to 15, 30,45, 60 minutes | 15minutes | 25~60min | 5~30min |
Table.1 Comparison table between the subject device and the selected predicate devices
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
| Comparison items | Subject device | Secondary Predicate devices | Primary predicate device |
|---|---|---|---|
| withComplianceVoluntaryStandards? | IEC60601-1-2IEC60601-1IEC60601-1-11IEC60601-2-10 | IEC60601-1-2IEC60601-1IEC60601-1-11IEC60601-2-10 | IEC60601-1-2IEC60601-1IEC60601-1-11IEC60601-2-10 |
| Compliance with 21CFR 898? | Yes | Yes | Yes |
| Weight | (the weight that included the internal batteryand the electrodes on the stimulator)uLumb-9530A: 2700guLumb-9531A: 2400guLumb-9532A: 1800guLumb-9533A: 2000gLQ-9525B: 750guNeck-9512A: 141guNeck-9515A: 146guNeck-9517B: 172guNeck-9518A: 172guNeck-9519A: 172guNeck-9521A: 156guNeck-9529A: 177gLQ-9535A: 320g | 2.1kg (Without accessories) | Unit: 1704.5g |
| Dimensions | Dimensions of the stimulator body [LWH]:uLumb-9530A: 35139288mmuLumb-9531A: 36532583mmuLumb-9532A: 35129888mmuLumb-9533A: 469.5348102mmLQ-9525B: 261267104mmuNeck-9512A: 15414937mmuNeck-9515A: 15214743mmuNeck-9517B: 18015140mmuNeck-9518A: 15291178mmuNeck-9519A: 17815291mm | 429.2mm x 401mm x 152.8mm | AST-622 Unit:456mm×354mm×86.7mmStainless steel:For AST-622: 224mm×96mm |
| Comparison items | Subject device | Secondary Predicate devices | Primary predicate device |
| uNeck-9521A: 14514336mmuNeck-9529A: 15214740mm | |||
| LQ-9535A: 1959245mm | |||
| Dimensions of each electrode on the stimulator | |||
| [L*W,thickness]: | |||
| uLumb-9532A:uLumb-9530A,(Spec.1) | |||
| 98.3×84×0.5mm, (Spec.2) 86×66×0. 5mm | |||
| uLumb-9531A:(Spec.1)81×60×0.5mm. | |||
| (Spec.2) 87×84×0. 5mm | |||
| (Spec.1)uLumb-9533A:40.8×40.8×0.5 ,(Spec.2) 40.8×40.8×0.5 mm | |||
| LQ-9525B: 114.8×55.7×62 mm | |||
| uNeck-9512A, uNeck-9515A, uNeck-9517B, | |||
| uNeck-9518A, uNeck-9521A, uNeck-9529A: | |||
| 26.6×41.8×0.3mm | |||
| uNeck-9519A: (Spec.1) 20.7×31.8×0.4 mm, | |||
| (Spec.2) 21.7×31 .8×0.4 mm | |||
| LQ-9535A: 51×33×0.4mm | |||
| Dimensions of an additional gel electrode | |||
| [L*W,thickness]: | |||
| uLumb-9530A.uLumb-9531A,uLumb- | |||
| uLumb-9533A, LQ-9525B9532A. | |||
| 40×70×3mm | |||
| uNeck-9512A, uNeck-9515A, uNeck-9517B, | |||
| uNeck-9518A, uNeck-9519A, uNeck-9521A, | |||
| uNeck-9529A, LQ-9535A: not applicable | |||
| HousingMaterials | ABS and PC plastic enclosure | ABS plastic | Main unit: ABS Plastic, Stainless steelRed Transparent Plastic: ABS plastic |
| and Construction | Electrode on the stimulator: metal | Not publicly available | Electrode pads: stainless steel plate |
| Electrodes materials | Additional gel electrode: conductive hydrogel | Electrode pads: White silica gel, Black |
{11}------------------------------------------------
{12}------------------------------------------------
| Comparison items | Subject device | Secondary Predicate devices | Primary predicate device | ||
|---|---|---|---|---|---|
| Biocompatibilitysafety | ISO10993-1ISO10993-5ISO10993-10 | ISO10993-1ISO10993-5ISO10993-10 | ISO10993-1ISO10993-5ISO10993-10 | ||
| Accessories | Remote control,adapter, gel electrodesand externalconnection coupling | Remote control, andadapter | Remote control, adapter, electrodepads and electrode wire | ||
| Waveform(e.g.,pulsed monophasic,biphasic) | Pulsed, symmetric, biphasic | Pulsed, symmetric, biphasic | Symmetric Biphasic | ||
| Shape(e.g.,rectangular, spike,rectified sinusoidal) | Rectangular, with interphase interval | Rectangular, with interphase interval | Rectangular | ||
| MaximumVoltage (Vp) | (+/-20%)$40V@500\Omega$$120V@2k\Omega$$140V@10k\Omega$ | (+/-20%)$21.6V@500\Omega$$32V@2k\Omega$$36V@10k\Omega$ | (+/-10%)$44V@500\Omega$$80V@2k\Omega$$112V@10k\Omega$ | (+/-10%)$23.2V@500\Omega$$39.2V@2k\Omega$$73.2V@10k\Omega$ | |
| MaximumOutputCurrent (mAp) | (+/-20%)$80mA@500\Omega$$60mA@2k\Omega$$14mA@10k\Omega$ | (+/-20%)$43.2mA@500\Omega$$16mA@2k\Omega$$3.6mA@10k\Omega$ | (+/-10%)$88mA@500\Omega$$40mA@2k\Omega$$11.2mA@10k\Omega$ | (+/-10%)$46.4mA@500\Omega$$19.6mA@2k\Omega$$7.32mA@10k\Omega$ | |
| Pulse(µsec) | Duration | 0~200µs +/-10% | 120µs | 180µs | |
| Frequency (Hz) | 1~100Hz +/-10% | 77.3Hz | 133Hz | ||
| Formultiphasic | Symmetricalphases? | Not applicable | Not applicable | Not applicable | Not applicable |
| waveforms only: | PhaseDuration | Not applicable | Not applicable | Not applicable | Not applicable |
| Comparison items | Subject device | Secondary Predicate devices | Primary predicate device | ||
| n(includeunits),(staterange, ifapplicable), (bothphases,ifasymmetrical) | |||||
| NetCharge(microcoulombs (µC)per pulse) (If zero,state method ofachieving zero netcharge.) | 0μC@500Ω | 0μC@500ΩMethod: Balanced waveform | 0μC@500ΩMethod: Balanced waveform | ||
| MaximumPhaseCharge, (µC) | 19.90μC@500Ω | 10.56μC@500Ω | 8.352μC@500Ω | ||
| Maximum AverageCurrent (averageabsolute value), mA | 11.8mA@500Ω | 1.63mA@500Ω | 4.44mA@500Ω | ||
| Maximum CurrentDensity,(mA/cm²,r.m.s.) | uLumb-9530A,uLumb-9532A,uLumb-9531A:0.469mA/cm²@500ΩuLumb-9533A:0.859mA/cm²@500ΩLO-9525B: | uNeck-9512A,uNeck-9515A,uNeck-9517B,uNeck-9518A,uNeck-9521A,uNeck-9529A:0.786mA/cm²@500ΩuNeck-9519A: | 0.0326mA/cm²@500Ω | Not publicly available | |
| Comparison items | Subject device | Secondary Predicate devices | Primary predicate device | ||
| 0.923mA/cm²@500Ω | 1.337mA/cm²@500ΩLQ-9535A:0.508mA/cm²@500Ω | ||||
| Maximum AveragePower Density,(W/cm²), (usingsmallest electrodeconductive surfacearea) | uLumb-9530A,uLumb-9532A,uLumb-9531A:0.0028W/cm²@500ΩuLumb-9533A:0.0051W/cm²@500ΩLQ-9525B:0.0055W/cm²@500Ω | uNeck-9512A,uNeck-9515A,uNeck-9517B,uNeck-9518A,uNeck-9521A,uNeck-9529A:0.0027W/cm²@500ΩuNeck-9519A:0.0046W/cm²@500ΩLQ-9535A:0.0017W/cm²@500Ω | 0.0000266mW/cm²@500Ω | 0.225mW/cm²@500Ω | |
| BurstMode (i.e., pulsetrains): | (a)Pulsesper burst | Not applicable | Not applicable | Not applicable | Not applicable |
| (b)Burstspersecond | Not applicable | Not applicable | Not applicable | Not applicable | |
| (c) Burstduration(seconds) | Not applicable | Not applicable | Not applicable | Not applicable | |
| (d) DutyCycle:Line (b)x Line | Not applicable | Not applicable | Not applicable | Not applicable |
{13}------------------------------------------------
{14}------------------------------------------------
{15}------------------------------------------------
| Comparison items | Subject device | Secondary Predicate devices | Primary predicate device |
|---|---|---|---|
| (c) | |||
| ON Time (seconds) | 1s | 240μs | 2s |
| OFF Time (seconds) | ≥2s | 12700μs | 2s |
Similarity and Difference
Based on the comparison information, we can determine that the subject device is almost identical to or within the range of the predicate devices selected in all aspect, except for power source, method of current leakage current, design of output channels, weight and dimensions, specification of electrodes equipped. On the subject device has the same range of intended use and provides the same functions by the same operating principle as the predicate devices. Although there specifications different between the subject devices, the subject device has undergone and passed a series of safety tests complied with the specific FDA-recognized consensus standards to demonstrate these differences would not adversely impact the safety and effectiveness of the subject device. Therefore, the differences between the subject devices would not raise any problem in substantial equivalence claims.
{16}------------------------------------------------
VII. Performance Data
The following performance data (nonclinical testing) were provided in support of the substantial equivalence determination.
1) Biocompatibility Safety
The materials of the patient-directly contacting components of the Electronic Stimulator is performed the biocompatibility evaluation in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing Within a Risk Management Process, Document issued on Sep. 4, 2020", as recognized by FDA. The battery of testing was performed to, and passed, including:
-
ISO 10993-5 Biological Evaluation of Medical Devices -Par t 5: Tests for In Vitro Cytotoxicity
-
ISO 10993-10 Biological Evaluation of Medical Devices –Par t 10: Tests for Irritation and Skin Sensitization
2) EMC and Electrical Safety
Electrical safety and Eye safety testing was performed to, and passed, the following standards:
-
IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
-
IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-11 Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
-
IEC 60601-2-10 Medical electrical equipment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
3) Software Verification and Validation
Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
4) Other Performance Verification
-
The electrodes performance test has been conducted to verify the current dispersion and shelflife of the electrodes used by the device in the expiration date according to the requirements of the FDA Guidance -Shelf Life of Medical Device and ASTM F1980-07 Standard.
-
The waveform and output test has also been conducted to verify the output specifications of the device according to the FDA Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning.
Summary
Based on the above performance as documented in this application, the Electronic Stimulator was found to have a safety and effectiveness profile that is similar to the predicate device.
VIII. Clinical Testing Summary
Not applicable. Clinical testing was not performed to support this 510(k) submission.
{17}------------------------------------------------
IX. Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design, materials and performance, the Electronic Stimulator is to be concluded substantial equivalent to its predicate devices.
§ 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).