(580 days)
The Smart Neck Stimulator is designed to temporarily relieve pain associated with sore and aching muscles in the back of neck due to strain from exercise or normal household work activities.
The subject device is intended to use on back of neck and it designed accord with human body cervical physiological curvature of streamlined ring design. The device totally has 3 modes and each mode has 15 output Intensity Levels, so the device can give certain electrical pulse through the electrode pads on the skin to help users to enjoy back neck stimulation. It can also provide a constant temperature of 37°C to 41°C to provide a warming sensation. The subject device can be controlled by a remote control which based on the radiofrequency technology. There are 5 buttons in the remote control, the "M" button for modes selection, "+" or "-" button for intensity selected to increase or decrease, the " "" button intends to turn the heating function on and the " Ho button intends to turn the heating function off. The device can be turned on when both power button on subject device has been turned on and the treatment mode can be selected by the remote control.
The provided text is a 510(k) Summary for the "Smart Neck Stimulator" (K200558). This document primarily focuses on demonstrating substantial equivalence to predicate devices based on device description, intended use, and conformance to electrical safety, EMC, and biocompatibility standards through bench testing.
Therefore, the information required to answer questions regarding acceptance criteria, study design (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), training set details, and ground truth establishment is not available in this document. The document details the physical and electrical safety characteristics rather than performance in a clinical, diagnostic, or AI-assisted scenario.
The document's "Test Summary" and "Comparison to Predicate Device and Conclusion" sections refer to safety and performance by lab bench testing and adherence to standards, not clinical or AI-based performance studies.
Here's what can be extracted from the document:
- Device Name: Smart Neck Stimulator (Model: 4098 (RED))
- Product Code: NUH
- Regulation Number: 21 CFR 882.5890
- Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief
- Regulatory Class: Class II
- Intended Use/Indications for Use: The Smart Neck Stimulator is designed to be used to temporarily relieve pain associated with sore and aching muscles in the back of neck due to strain from exercise or normal household work activities.
- Type of Use: Over-The-Counter Use
- Predicate Devices:
- Tests Performed (Bench Testing for Safety and Performance):
- IEC 60601-1 (General Requirements For Basic Safety And Essential Performance)
- IEC 60601-1-2 (Electromagnetic compatibility)
- IEC 60601-2-10 (Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators)
- IEC 60601-1-11 (Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment)
- IEC 62133-2 (Secondary Cells And Batteries - Safety Requirements for Lithium Systems)
- IEC 62366-1 (Medical Devices - Application Of Usability Engineering To Medical Devices)
- ISO 10993-5 (Biological evaluation of medical devices - Tests for In Vitro cytotoxicity)
- ISO 10993-10 (Biological evaluation of medical devices - Tests for irritation and skin sensitization)
Regarding the specific questions posed:
-
A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Implicitly, the acceptance criteria are compliance with the referenced IEC/ISO standards (e.g., electrical safety limits, biocompatibility standards, EMC limits) and demonstration that the device's technical specifications are comparable to or within acceptable limits relative to predicate devices, and would not raise new safety or effectiveness concerns.
- Reported Device Performance: The document lists the device's specifications (e.g., output voltage, current, pulse duration, frequency, heating temperature, dimensions, weight) and states that bench tests were performed and results "complied with the test requests" and "meet the safety standards." However, it does not provide specific numerical performance results against an acceptance criterion in a tabular format beyond listing the device's characteristics and noting compliance.
Example (Structured as requested, but data is qualitative in the document):
| Acceptance Criteria Category | Specific Criteria (Implicitly from Standards & Predicate Comparison) | Reported Device Performance (Summary from Document) |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-2-10, IEC 60601-1-11, IEC 62133-2 standards, and comparable to predicate devices for parameters like patient leakage current, average current through electrodes. | "results complied with the test requests" and "meet the safety standards IEC 60601-1 and IEC 60601-1-11." Specific values are provided for comparison to predicates (e.g., Patient Leakage Current NC, Average current through electrodes <10µA), deemed acceptable. |
| Electromagnetic Comp. | Compliance with IEC 60601-1-2 standard. | "results complied with the test requests" and "meet the safety standards." |
| Biocompatibility | Compliance with ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and skin sensitization) standards. | "results complied with the test requests" and "meet the safety standards." |
| Usability Engineering | Compliance with IEC 62366-1 standard. | "results complied with the test requests" and "meet the safety standards." |
| Mechanical/Physical | Specifications (Weight, Dimensions, Pad dimensions) deemed not to adversely impact safety/effectiveness compared to predicates. | Differences in physical dimensions (weight, dimensions, pad size) exist but are deemed not to impact safety and effectiveness, as they "meet the safety standards." |
| Performance Parameters | Electrical output parameters (Voltage, Current, Pulse Duration, Frequency, Net Charge, Phase Charge, Average Current, Current Density, Power Density) within acceptable range and comparable to predicates. | Specific values are listed (e.g., Max Output Voltage 76V±10% @500Ω, Pulse frequency 1-200Hz). Differences from predicates are noted but "would not adversely impact the safety and effectiveness" as they "meet the safety standards." |
| Operational Features | Number of modes, intensity levels, heating function, timer range, automatic shut-off, etc., comparable to or within acceptable variations from predicates. | Values listed (e.g., 3 modes, 15 intensity levels, 15 min timer). Differences from predicates (e.g., timer range, output intensity) are noted but deemed not to impact safety/effectiveness as they "meet the safety standards." |
- Sample size used for the test set and the data provenance: Not applicable. This document describes bench testing and comparisons to predicate device specifications, not clinical or AI-based performance studies with patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical or AI performance was not established. The "experts" involved would be the engineers and technicians performing the standard electrical, mechanical, and biological tests.
- Adjudication method: Not applicable. No clinical test set requiring adjudication.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. This device is a Transcutaneous Electrical Nerve Stimulator for pain relief, not an imaging analysis AI device that would typically involve MRMC studies.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical device, not an AI algorithm.
- The type of ground truth used: Not applicable in the context of clinical or AI performance. The "ground truth" for this submission is regulatory compliance based on engineering and safety standards (e.g., a specific resistance value is 500 Ohm, a voltage reading must be within a certain tolerance as defined by the standard).
- The sample size for the training set: Not applicable. No AI model was trained.
- How the ground truth for the training set was established: Not applicable. No AI model was trained.
In summary, this 510(k) submission establishes substantial equivalence through a detailed comparison of the subject device's design, intended use, and technical specifications against existing predicate devices and by demonstrating adherence to recognized safety and performance standards via bench testing. It does not involve AI model performance evaluations, clinical studies with patient data, or expert-adjudicated ground truth.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and 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.
October 4, 2021
Guandong Skg Intelligent Technology Co., Ltd Fanny Yuan Manager No.1, 7/F. Yingfeng Business Center, No.8 Yixing Road, Beijiao Town Shunde District, Foshan City, Guandong Province 528303 China
Re: K200558
Trade/Device Name: Smart Neck Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: August 26, 2021 Received: September 1, 2021
Dear Fanny Yuan:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
{1}------------------------------------------------
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 (OS) 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 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).
Sincerely,
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K200558
Device Name Smart Neck Stimulator (Model: 4098 (RED))
Indications for Use (Describe)
The Smart Neck Stimulator is designed to temporarily relieve pain associated with sore and aching muscles in the back of neck due to strain from exercise or normal household work activities.
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 of K200558
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.
- � Company Name: GUANGDONG SKG INTELLIGENT TECHNOLOGY CO., LTD
- Establishment Registration Number: Applying �
- Address: No.1, 7/F, Yingfeng Business Center, No.8 Yixing Road, Beijiao Town, Shunde District, � Foshan City, Guangdong Province, China
- � Postal Code: 528303
- � Phone: +86 18231193066
- � TEL: +86 40 0822 0888
- Contact Person (including title): Mao Hui Zhang (Certificated Engineer) �
- E-mail: zhangmaohui@skg.com �
2. Manufacturer
- Company Name: Guangdong Shiqi Manufacture Co., Ltd �
- � Address: D10-11, Lunjiao Intensive Industrial Zone, Licun Village Committee, Lunjiao Street Office, Shunde District, Foshan City, Guangdong Province, China
- Phone: +86 18231193066 �
- � Tel: +86 40 0822 0888
- Contact Person: Mao Hui Zhang �
3. Application Correspondent:
- � Company: Share Info (Guangzhou) Medical Consultant Ltd.
- � Contact Name: Ms. Fanny Yuan
- E-mail: medical-device@qq.com �
4. Subject Device Information
- Smart Neck Stimulator � Trade Name:
- Transcutaneous Electrical Nerve Stimulator for Pain Relief Common Name: �
- Stimulator, nerve, transcutaneous, over-the-counter � Classification name:
- Neurology, Physical Medicine Review Panel: �
- NUH Product Code: �
- ll � Regulation Class:
- 882.5890 Regulation Number: �
5. Predicate Device Information
{4}------------------------------------------------
| Sponsor | HIVOX BIOTEK INC. | Shenzhen OSTO Technology Co.,Ltd. |
|---|---|---|
| Device Name andModel | HIVOX OTC Electrical Stimulator | Neck Care Therapy |
| 510(k) Number | K171803 | K172897 |
| Product Code | NUH, NGX | NUH, NGX |
| Regulation Number | 882.5890, 890.5850 | 882.5890, 890.5850 |
| Regulation Class | II | II |
6. Device Description
The subject device is intended to use on back of neck and it designed accord with human body cervical physiological curvature of streamlined ring design.
The device totally has 3 modes and each mode has 15 output Intensity Levels, so the device can give certain electrical pulse through the electrode pads on the skin to help users to enjoy back neck stimulation. It can also provide a constant temperature of 37°C to 41°C to provide a warming sensation. The subject device can be controlled by a remote control which based on the radiofrequency technology. There are 5 buttons in the remote control, the "M" button for modes selection, "+" or "-" button for intensity
selected to increase or decrease, the " "" button intends to turn the heating function on and the " Ho button intends to turn the heating function off.
The device can be turned on when both power button on subject device has been turned on and the treatment mode can be selected by the remote control.
7. Intended Use / Indications for Use
The Smart Neck Stimulator is designed to be used to temporarily relieve pain associated with sore and aching muscles in the back of neck due to strain from exercise or normal household work activities.
8. Test Summary
Smart Neck Stimulator has been evaluated the safety and performance by lab bench testing as following:
| Standards No. | Standard Title | Version | Date |
|---|---|---|---|
| IEC 60601-1 | Medical Electrical Equipment - Part 1:General Requirements For Basic SafetyAnd Essential Performance | 2005/(R)2012 AndA1:2012, | 07/09/2014 |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2:General requirements for basic safetyand essential performance - Collateralstandard: Electromagnetic compatibility- Requirements and tests | Edition 4.0 2014-02 | 09/17/2018 |
| IEC 60601-2-10 | Medical Electrical Equipment - Part 2-10: Particular Requirements For TheBasic Safety And EssentialPerformance Of Nerve And MuscleStimulators | Edition 2.1 2016-04 | 06/07/2018 |
{5}------------------------------------------------
| Standards No. | Standard Title | Version | Date |
|---|---|---|---|
| IEC 60601-1-11 | Medical electrical equipment - Part 1-11:General requirements for basic safetyand essential performance - CollateralStandard: Requirements for medicalelectrical equipment and medicalelectrical systems used in the homehealthcare environment | Edition 2.0 2015-01 | 06/27/2016 |
| IEC 62133-2 | Secondary Cells And BatteriesContaining Alkaline Or Other Non-AcidElectrolytes - Safety Requirements ForPortable Sealed Secondary Cells, AndFor Batteries Made From Them, ForUse In Portable Applications - Part 2:Lithium Systems | Edition 1.0 2017-02 | 01/14/2019 |
| IEC 62366-1 | Medical Devices - Part 1: Application OfUsability Engineering To MedicalDevices | Edition 1.0 2015-02 | 12/23/2016 |
| ISO 10993-5 | Biological evaluation of medical devices- Part 5: Tests for In Vitro cytotoxicity | Third Edition 2009-06-01 | 12/23/2016 |
| ISO 10993-10 | Biological evaluation of medical devices- Part 10: Tests for irritation and skinsensitization | Third Edition 2010-08-01 | 07/26/2016 |
9. Comparison to predicate device and conclusion
The Smart Neck Stimulator has similar intended use, technological characteristics and same principle of operation as these predicate devices. Although there are several specifications different between these devices, the comparison analysis has been completed to demonstrate that the differences between these parameters would not adversely impact the safety and effectiveness of the subject device has undergone safety and performance tests, and the results complied with the test requests. Therefore the differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements ofComparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | |
|---|---|---|---|---|---|
| Company | GUANGDONG SKGINTELLIGENTTECHNOLOGY CO., LTD | HIVOX BIOTEK INC. | Shenzhen OSTOTechnology Co., Ltd. | -- | |
| Trade Name | Smart Neck Stimulator | HIVOX OTC ElectricalStimulator | Neck Care Therapy | -- | |
| ClassificationName | Stimulator, nerve,transcutaneous, over-the-counter | Stimulator, nerve,transcutaneous, over-the-counter | Stimulator, nerve,transcutaneous, over-the-counter,Stimulator, Muscle,Powered, For MuscleConditioning | -- | |
| 510(k) Number | K200558 | K171803 | K172897 | -- | |
| Elements ofComparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | |
| Product Code | NUH | NUH, NGX | NUH, NGX | SE | |
| Intended Use /Indications forUse | The Smart NeckStimulator is designed tobe used to temporarilyrelieve pain associatedwith sore and achingmuscles in the back ofneck due to strain fromexercise or normalhousehold work activities. | HIVOX OTC ElectricalStimulator, SEM44:TENS: The device isdesigned to be usedfor temporary relief ofpain associated withsore and achingmuscles in theshoulder, waist, back,neck, upperextremities (arm),lower extremities(leg), abdomen andbottom due to strainfrom exercise ornormal householdwork activities.EMS: The device isdesigned to be usedfor stimulate healthymuscles in order toimprove and facilitatemuscle performance.HIVOX OTC ElectricalStimulator, SEM44-1:TENS: The device isdesigned to be usedfor temporary relief ofpain associated withsore and achingmuscles in theshoulder, waist, back,neck, upperextremities (arm),lower extremities(leg), abdomen andbottom due to strainfrom exercise ornormal householdwork activities. | To be used fortemporary relief ofpain associated withsore and achingmuscles in theshoulder, waist, backof neck, back, arm,and leg, due to strainfrom exercise ornormal householdand work activities.- Neck Pad isused in back of neck.- Meridian Padis used in shoulder,waist, back, and arm. | SE | |
| Type of use | OTC | OTC | OTC | SE | |
| Elements ofComparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | |
| Power source | 3.7V, 1500mAh lithiumbattery | 4.5V (batteries,3x1.5V AAA) | For the poweradaptor:Input: 100~240Vac50/60Hz, 0.2A;Output: 5Vdc, 1AUnit Input: 5Vdc, 1AFor Battery: 3.7 Vdc,500mAhFor Remote Control:(2x1.5V AAA battery) | SE | |
| Method of LineCurrentIsolation | Type BF Applied Part | Not publicly available | Type BF Applied Part | SE | |
| PatientLeakageCurrent | NC | 50 μΑ | Not publicly available | AC: 54.5μΑDC: 0.5µA | SE |
| SFC | 100 μΑ | Not publicly available | AC: 120μADC: 0.6μA | Note 2 | |
| Averagecurrent throughelectrodeswhen device ison but nopulses arebeing applied | <10μΑ | 0 | <0.01μA | SENote 2 | |
| Number ofOutput Modes | 3 | TENS: 15EMS: 35 | 2 | SE | |
| Heating Setting | On and off | Not publicly available | Not publicly available | SENote 2 | |
| Heatingtemperature | 37-41°C | Not publicly available | Not publicly available | SENote 2 | |
| OutputIntensity Level | 15 steps | Not publicly available | 50 steps | SENote 2 | |
| Number ofOutputChannels | 1 | 2 | Not publicly available | SENote 2 | |
| Synchronousor Alternating? | Synchronous | Synchronous | Synchronous | SE | |
| RegulatedVoltage orCurrent ? | Regulated voltage | Regulated voltage | Voltage Control | SE | |
| Software /Firmware /MicroprocessorControl? | Yes | Yes | Yes | SE | |
| AutomaticOverload Trip | No | Yes | No | SE | |
| Automatic No-Load Trip | Yes | Yes | No | SE | |
| Automatic ShutOff | Yes | Yes | Yes | SE | |
| User Override | Yes | Yes | Yes | SE | |
| Elements ofComparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | |
| Control | |||||
| Timer Range(minutes) | 15 min | 5-100 min | 5-30 min | SENote 2 | |
| Weight | Main Unit: 200g | 89 g (including beltclip, without batteries),123 g (including beltclip and batteries) | Main Unit: 222g | SENote 1 | |
| Dimensions | Main Unit: 141.4 mm x137.9 mm x 46 mm | 132 x 63 x 29.5 mm(including belt clip) | Main Unit:187.216967.3 mm | SENote 1 | |
| Pad dimension | 44.2 mm x 29.8 mm | 20.25 sqcm x4 (81sqcm) | 8.9 cm *5.8 cm | SENote 1 | |
| Housing unit | PC, ABS plastic | ABS | ABS plastic | SE | |
| Electrode padmaterial | Stainless steel | Not publicly available | Stainless steel | SE | |
| Waveform | Pulsed, symmetric,biphasic | Biphasic | Pulsed, symmetric,biphasic | SE | |
| Shape | Rectangular, withinterphase interval | Square | Rectangular, withinterphase interval | SE | |
| MaximumOutput Voltage | 76V±10% @500Ω106V±10% @2KΩ138V±10% @10KΩ | 100V±10%@500Ω180V±10% @2KΩ250V±10% @10KΩ | 44V±10% @500Ω80V±10% @2KΩ112V±10% @10KΩ | SENote 2 | |
| MaximumOutput Current | 152mA±10% @500Ω54mA±10% @2KΩ13.8mA±10% @10KΩ | 200mA±10% @500Ω90mA±10% @2KΩ25mA±10% @10KΩ | 88mA±10% @500Ω44mA±10% @2KΩ11.2mA±10%@10KΩ | SENote 2 | |
| Pulse Duration(μs) | Mode 1: 40μsMode 2: 200µsMode 3: 150µs | 50-450μs | 120μs | SENote 2 | |
| Pulsefrequency | 1-200Hz | 1-150Hz | 77.3Hz | SENote 2 | |
| Net Charge(per pulse) | 0µC @ 500ΩMethod: Balancedwaveform | 0.001 µC@500Ω | 0 µC@500ΩMethod: Balancedwaveform | SENote 2 | |
| MaximumPhase Charge@ 500Ω | 12.16 µC | 0.045 µC | 12.78 µC | SENote 2 | |
| MaximumAverageCurrent@500Ω | 3.9824 mA | 13.5mA | 0.968mA | SENote 2 | |
| MaximumCurrent Density(r.m.s) @ 500Ω | 0.390 mA/cm² | 0.667mA/cm² | 0.235mA/cm² | SENote 2 | |
| MaximumAverage PowerDensity @500Ω | 0.78mW/cm² | 0.00465W/cm² | 1.38mW/cm² | SENote 2 | |
| OperatingEnvironment | Temperature: +10~+40°CHumidity: 45% -85%RHAtmospheric Pressure: 86KPa – 106 KPa | Not publicly available | Temperature: 5~40°CHumidity: 15% -90%RHAtmosphericPressure: 700 hPa - | SE | |
| Elements ofComparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | |
| 1060 hPa | |||||
| StorageEnvironment | Temperature: -10~+50°CHumidity: <90%RHAtmospheric Pressure: 50KPa – 106 KPa | Not publicly available | Temperature: -25~70°CHumidity: ≤90%RHAtmosphericPressure: 700 hPa -1060 hPa | SE | |
| Biocompatibility | ISO 10993-5ISO 10993-10 | ISO 10993-5ISO 10993-10 | ISO 10993-5ISO 10993-10 | SE | |
| ElectricalSafety | IEC 60601-1IEC 60601-2-10IEC 60601-1-11IEC 62133-2 | IEC 60601-1IEC 60601-2-10 | IEC 60601-1IEC 60601-1-11IEC 60601-2-10 | SE | |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | SE |
{6}------------------------------------------------
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
Comparison in Detail(s):
Note 1:
The subject has been compared with predicate devices respectively. The "Weight", "Dimensions" and "Pad dimension" of subject device are a little different from predicate devices, but they won't impact safety and effectiveness of subject device. Because all of them are meet the safety standards, the differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
Note 2:
The subject has been compared with predicate devices respectively. The subject device has several technological characteristics, "Number of Output Channels", "Patient Leakage Current", "Average current through electrodes when device is on but no pulses are being applied", "Heating Setting", "Heating temperature", "Output Intensity Level", "Timer Range (minutes)", "Maximum Output Voltage", "Maximum Output Current", "Pulse Duration", "Pulse frequency", "Met Charge (per pulse)", "Maximum Phase Charge @ 500Ω", "Maximum Average Current@ 500Ω", "Maximum Current Density (r.m.s) @ 500Ω " and "Maximum Average Power Density @ 500Ω" are a little different from these predicate devices, but the comparison analysis has been completed to demonstrate that the differences between these parameters would not adversely impact the safety and effectiveness of the subject device. Because all of them are meet the safety standards IEC 60601-1 and IEC 60601-1-11, the differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device. Therefore, the subject device is substantially equivalent to the predicate devices K171803 and K172897.
Final Conclusion:
After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that the Smart Neck Stimulator (Model: 4098 (RED)) is substantially equivalent to the predicate devices K171803 and K172897.
10. Date of the summary prepared: October 5, 2021
§ 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).