(333 days)
Model SM9187:
TENS (Mode 1, 3, 4, 5, 6):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS (Mode 1, 2, 3, 4, 5, 6):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Model SM9180L & SM9180S:
TENS (Mode 1. 3. 4. 5. 6):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back due to strain from exercise or normal household work activities.
PMS (Mode 1, 2, 3, 4, 5, 6):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Sunmas TENS & PMS (Model SM9187, SM9180L & SM9180S) is a portable battery powered device with a wireless feature for over-the-counter use, offering both Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS) qualities in one device. Sunmas TENS & PMS has totally 6 modes, applying electrical current to electrodes on a patient's skin to relieve pain or build up muscle. Due to different electrode shapes and sizes, Model SM9187 can be used on the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (legs), while Model SM9180L and SM9180S can be used on the shoulder, back and abdomen. Model SM9187 is designed to be controlled by a mobile phone application program (APP) named “Dr.Stim”, through Bluetooth 4.0 technology (Frequency: 2402.0 - 2480.0MHz). The APP is developed by Hong Qiangxing (Shenzhen) electronics Limited. SM9187 consists of a round main unit, two sets of self-adhesive electrode pad, a mobile application (APP), an AC charger and a USB cable. Model SM9180L and SM9180S both have a butterfly-shaped main unit (Frequency: 2450MHz) and can be remotely controlled through wireless technology. SM9180L has a black remote control with an electronic display screen which is powered by two AAA alkaline batteries, while Model SM9180S has a white remote control powered by a CR2032 coin battery. The radio frequency of remote control (both black and white) is 2405.0 - 2470.0MHz. Model SM9180L and SM9180S consists of a unit, two pairs of electrode gels, a remote control (black or white), an AC charger and a USB cable.
This document is a 510(k) Pre-Market Notification for a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) device. The purpose of this notification is to demonstrate that the new device, Sunmas TENS & PMS (Models SM9187, SM9180L, SM9180S), is substantially equivalent to legally marketed predicate devices.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies, as requested:
1. A table of acceptance criteria and the reported device performance
The provided document doesn't explicitly present a table of "acceptance criteria" in the sense of predefined performance thresholds for a clinical study. Instead, it compares the technical specifications and safety standards compliance of the new device with those of its predicate devices to demonstrate substantial equivalence. The implicit "acceptance criteria" are that the new device's specifications and safety performance are comparable to or meet the standards of the predicate devices.
Below is a table summarizing key comparative performance metrics, drawn directly from the "Substantial Equivalence to Predicate device" tables (Table 1 and Table 2) within the document. The "Reported Device Performance" for the new device is its own specifications, and the "Acceptance Criteria" are implied by the predicate device's specifications and the statement that the new device is "safe and effective as the predicate devices cited above."
| Parameter | New Device (SM9187) Reported Performance | Predicate Device 1 (K121719) Implied Acceptance Criteria | Predicate Device 2 (K143430) Implied Acceptance Criteria |
|---|---|---|---|
| Number of Output Modes | 6 | 6 | 7 |
| Number of Output channels | 1 | 2 | 1 |
| Waveform | Biphasic rectangular, Monophasic rectangular | Biphasic rectangular, Monophasic rectangular | Biphasic rectangular, Monophasic rectangular |
| Patient Leakage Current (Normal Condition) | < 10µA | < 10µA | < 10µA |
| Patient Leakage Current (Single Fault Condition) | < 50µA | < 50µA | < 50µA |
| Average DC Current (No pulses) | < 0.01µA | < 0.01µA | < 0.01µA |
| Regulated Control | Voltage control | Voltage control | Voltage control |
| Max Output Voltage @500Ω | 47.6V±10% | 42V±10% | 68V |
| Max Output Current @500Ω | 95.2mA±10% | 84mA±10% | 133mA |
| Pulse width | 100µs | 100µs | 50-250µs |
| Max Pulse Frequency | 105.5Hz | 110Hz | 1-150Hz |
| Net Charge (per pulse) @500Ω | 0µC / 9.6µC | 0µC | 0µC / max 10.01µC |
| Max Phase Charge @500Ω | 19.04µC | 16.8µC | 20.02µC |
| Max Average Current | 1.004mA | 0.924mA | 3.0375mA |
| Max Current Density @500Ω | 0.11mA/cm² (19cm²) | 0.462mA/cm² (4cm²) | 0.066mA/cm² |
| Max Average Power Density @500Ω | 2.52mW/cm² (19cm²) | 9.702mW/cm² (4cm²) | 2.66mW/cm² |
| Wireless Control | Yes (Bluetooth, APP) | No | Yes (Bluetooth, APP) |
Note: The table for models SM9180L & SM9180S showed similarly comparable specifications to their predicate devices, with particular attention to wireless control and power sources. For brevity, only the first new device model (SM9187) is fully detailed above, but the same principle of demonstrating comparable specifications applies across all models.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not describe a clinical test set or patient data for performance evaluation. The evaluation is based on a comparison of technical specifications and compliance with recognized safety standards. There is no mention of a "sample size" in terms of patients or data, nor the provenance of such data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Since there was no clinical test set or patient data involved in a performance evaluation requiring expert interpretation or "ground truth" establishment, this information is not applicable and not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
As no clinical test set or patient data requiring adjudication was used, this information is not applicable and not provided.
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
The device described is a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS). It is a physical therapy device and does not involve AI assistance for "human readers" or image interpretation. Therefore, an MRMC comparative effectiveness study in this context is not applicable, and no such study was reported.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This device is not an algorithm or AI system. It is a physical medical device that delivers electrical stimulation. Therefore, the concept of "standalone (algorithm only)" performance does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given the nature of the device and the submission type (demonstrating substantial equivalence through technical specifications and safety standards compliance), no "ground truth" in the context of clinical disease manifestation or diagnostic interpretation was used. The "truth" in this submission lies in compliance with electrical safety standards and the device's physical and electrical properties matching established safe and effective parameters of predicate devices.
8. The sample size for the training set
As this is not an AI/ML device, there is no "training set" in the conventional machine learning sense.
9. How the ground truth for the training set was established
Since there is no training set, this information is not applicable.
Study Proving Acceptance Criteria:
The "study" demonstrating that the device meets "acceptance criteria" (understood as achieving substantial equivalence to predicate devices and complying with relevant safety standards) is a series of technical tests and evaluations against recognized voluntary standards. The document explicitly lists the following standards to which the new device has been tested and found compliant:
- ANSI AAMI ES60601-1: 2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) - Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.
- IEC 60601-2-10 Edition 2.1 2016-04 - Medical Electrical Equipment - Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators.
- ANSI AAMI IEC 60601-1-2:2014 - Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests.
- IEC 62133 Edition 2.0 2012-12 - Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications.
- IEC 60601-1-11 Edition 2.0 2015-01 - Medical Electrical Equipment - Part 1-11: 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.
- FCC 47 CFR Part 15 - Radio Frequency Devices.
- AAMI TIR69: 2017 - Technical Information Report Risk Management Of Radio-Frequency Wireless Coexistence For Medical Devices And Systems.
- ANSI IEEE C63.27-2017 - American National Standard For Evaluation Of Wireless Coexistence.
These tests likely involved engineering evaluations, bench testing, and potentially electromagnetic compatibility (EMC) testing to ensure the device's electrical safety, functional performance within specified parameters, and safe operation in its intended environment, similar to the predicate devices. The successful completion of these tests provides the evidence that the device meets the implied acceptance criteria for safety and performance as a TENS/PMS device.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which stands for U.S. Food & Drug Administration. The FDA logo is in blue.
December 2, 2019
Hong Qiangxing (Shen Zhen) Electronics Limited % Doris Dong Manager Shanghai CV Technology Co., Ltd. Room 903, No. 19 Dongbao Road, Songjiang Area Shanghai, 201613 China
Re: K190009
Trade/Device Name: Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: November 27, 2018 Received: January 3, 2019
Dear Doris Dong:
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,
For Vivek Pinto, Ph.D. Acting Division 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
Enclosure
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Indications for Use
510(k) Number (if known) K190009
Device Name
Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)
Indications for Use (Describe) Model SM9187:
TENS (Mode 1, 3, 4, 5, 6):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS (Mode 1, 2, 3, 4, 5, 6):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Model SM9180L & SM9180S:
TENS (Mode 1. 3. 4. 5. 6):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back due to strain from exercise or normal household work activities.
PMS (Mode 1, 2, 3, 4, 5, 6):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
[As required by 21 CFR 807.92]
1. Submission Information:
| 510(k) Number: | K190009 |
|---|---|
| Date: | December 12, 2019 |
| Type of 510(k) Submission: | Traditional |
| Basis for 510(k) Submission: | New device |
| Submitter/Manufacturer: | Hong Qiangxing (Shen Zhen) Electronics Limited4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District,Shenzhen City, Guangdong, China 518126 |
| Contact: | Doris Dong[Consultant, from Shanghai CV Technology Co., Ltd.]Add: Room 903, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 ChinaE-mail: doris_d@126.comTel: 86 21-31261348 / Fax: 86 21-57712250 |
| 2. Device Description: | |
| Proprietary Name: | Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) |
| Common Name: | TENS & PMS |
| Classification Name: | Stimulator, nerve, transcutaneous, over-the-counter,Stimulator, muscle, powered, for muscle conditioning |
| Regulation Number: | 882.5890, 890.5850 |
| Product Code: | NUH, NGX |
| Device Class: | II |
| Review Panel: | Neurology & Physical Medicine |
| Device Description: | Sunmas TENS & PMS (Model SM9187, SM9180L & SM9180S) is aportable battery powered device with a wireless feature for over-the-counteruse, offering both Transcutaneous Electrical Nerve Stimulation (TENS) andPowered Muscle Stimulation (PMS) qualities in one device.Sunmas TENS & PMS has totally 6 modes, applying electrical currentto electrodes on a patient's skin to relieve pain or build up muscle.Due to different electrode shapes and sizes, Model SM9187 can beused on the shoulder, waist, back, neck, upper extremities (arm), and lowerextremities (legs), while Model SM9180L and SM9180S can be used on theshoulder, back and abdomen.Model SM9187 is designed to be controlled by a mobile phoneapplication program (APP) named “Dr.Stim”, through Bluetooth 4.0technology (Frequency: 2402.0 - 2480.0MHz). The APP is developed byHong Qiangxing (Shenzhen) electronics Limited. SM9187 consists of around main unit, two sets of self-adhesive electrode pad, a mobileapplication (APP), an AC charger and a USB cable.Model SM9180L and SM9180S both have a butterfly-shaped main unit(Frequency: 2450MHz) and can be remotely controlled through wirelesstechnology. SM9180L has a black remote control with an electronic displayscreen which is powered by two AAA alkaline batteries, while SM9180S |
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has a white remote control powered by a CR2032 coin battery. The radio frequency of remote control (both black and white) is 2405.0 - 2470.0MHz. Model SM9180L and SM9180S consists of a unit, two pairs of electrode gels, a remote control (black or white), an AC charger and a USB cable. Model SM9187:
Indications for use:
TENS (Mode 1, 3, 4, 5, 6):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS (Mode 1, 2, 3, 4, 5, 6):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Model SM9180L & SM9180S:
TENS (Mode 1, 3, 4, 5, 6):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back due to strain from exercise or normal household work activities.
PMS (Mode 1, 2, 3, 4, 5, 6):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
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3. Substantial Equivalence to Predicate device:
Table 1 -
| Parameters | New Device | Predicate Device 1 | Predicate Device 2 | ||
|---|---|---|---|---|---|
| 1. | 510(k) Number: | K190009 | K121719 | K143430 | |
| 2. | Marketing clearance date: | May 10, 2013 | May 10, 2013 | May 29, 2015 | |
| 3. | Device Name | SM9187 | SM TENS & PMS | SmartTENS | |
| 4. | Manufacturer | Hong Qiangxing (Shenzhen) Electronics Limited | Hong Qiangxing (Shenzhen) ElectronicsLimited | EasyMed Instruments Co., Ltd. | |
| 5. | Product code | NUH, NGX | NGX, NUH | NUH | |
| 6. | Accessories | Self-adhesive electrodes, Battery charger, USB cable | Self-adhesive electrodes, electrode wires, Batterycharger, USB cable | Button-affixed electrode, Replaceable HydrogelPads( (gel-pads) )73mm x 62mm, charger cradle,charging adapter | |
| 7. | Intended use | TENS (Mode 1, 3, 4, 5, 6):To be used for temporary relief of pain associatedwith sore and aching muscles in the shoulder,waist, back, neck, upper extremities (arm), andlower extremities (leg) due to strain from exerciseor normal household work activities.PMS (Mode 1, 2, 3, 4, 5, 6):It is intended to be used to stimulate healthymuscles in order to improve and facilitate muscleperformance. | TENS (Mode 1, 3, 4, 5, 6):To be used for temporary relief of pain associatedwith sore and aching muscles in the shoulder,waist, back, neck, upper extremities (arm), andlower extremities (leg) due to strain from exerciseor normal household work activities.PMS (Mode 1, 2, 3, 6):It is intended to be used to stimulate healthymuscles in order to improve and facilitate muscleperformance. | This device is intended for the relief of painassociated with sore or aching muscles of thelower back, arms, or legs due to strain fromexercise or normal household and work activities. | |
| 8. | Target Population | Adult | Adult | Adult | |
| 9. | Type of use | OTC | OTC | OTC | |
| 10. | Wireless Control | Yes(Bluetooth device controlled by Application) | No | Yes(Bluetooth device controlled by Application) | |
| 11. | Number of Output Modes | 6 | 6 | 7 | |
| 12. | Number of Output channels: | 1 | 2 | 1 | |
| - Synchronous or | NA | Synchronous | NA | ||
| Alternating? | |||||
| - Method of Channel | NA | Voltage transformer Isolation | NA | ||
| Isolation | |||||
| 13. | Waveform (e.g. pulsed | Biphasic rectangular | Biphasic rectangular | Biphasic rectangular | |
| monophasic, biphasic) | Monophasic rectangular | Monophasic rectangular | Monophasic rectangular | ||
| 14. | Power Source(s) | 3.7V rechargeable lithium battery | 3.7V rechargeable lithium battery | 3.7V rechargeable lithium battery | |
| - Method of Line Current | Type BF | Type BF | Type BF | ||
| Isolation | |||||
| - Patient Leakage Current | -- | -- | -- | ||
| - Normal Condition (μΑ) | < 10μΑ | < 10μΑ | Not publicly available | ||
| Single Fault Condition (μΑ) | < 50μΑ | < 50μA | Not publicly available | ||
| 15. | Average DC current through electrodes when | <0.01μA | <0.01μA | Not publicly available | |
| device is on but | |||||
| no pulses are being applied (µA) | |||||
| 16. | Regulated Current or Regulated | Voltage control | Voltage control | Not publicly available | |
| Voltage? | |||||
| 17. | Software/Firmware/Microprocessor Control? | Yes | Yes | Yes | |
| 18. | Automatic Overload Trip? | No | No | Yes | |
| 19. | Automatic No-Load Trip? | No | No | Yes | |
| 20. | Automatic Shut Off? | Yes | Yes | Yes | |
| 21. | User Override Control? | Yes | Yes | Yes | |
| 22. | Indicator | On/Off Status? | Yes | Yes | Yes |
| Display: | Low Battery? | No | Yes | Yes | |
| Voltage/Current | Yes | Yes | Yes | ||
| Level? | |||||
| Output mode | Yes | Yes | Yes | ||
| Time to cut-off | Yes | Yes | Yes | ||
| 23. | Timer Range (minutes) | 0 ~ 60 minutes | 10 ~ 60 minutes, 10 min./step | 20min, 25min, 30min, 40min depending onpreset program | |
| 24. | Weight (grams) | 43g | 140g | 64g | |
| 25. | Dimensions (mm) [W x H x D] | 60 x 60 x 13.7mm | 83429mm | 155.4 x 64.6 x 19.1mm | |
| 26. | Housing Materials &Construction | ABS | ABS | TPE & ABS | |
| 27. | Maximum Output Voltage (volts) | 47.6V±10% @500Ω | 42V±10% @500Ω | 68V@500Ω | |
| 104V±10% @2kΩ | 84V±10% @2kΩ | 102V@2kΩ | |||
| 157V±10% @10kΩ | 130V±10% @10kΩ | 110V@10kΩ | |||
| 28. | Maximum Output Current(specify units) | 95.2mA±10% @500Ω | 84mA±10% @500Ω | 133mA@500Ω | |
| 52mA±10% @2kΩ | 42mA±10% @2kΩ | 51mA@2kΩ | |||
| 15.7mA±10% @10kΩ | 13mA±10% @10kΩ | 11mA@10kΩ | |||
| 29. | Pulse width (μsec) | 100μs | 100μs | 50~250μs | |
| 30. | Pulse Period (msec) | 9.5~855ms | 9.3~850ms | Not publicly available | |
| 31. | Max. pulse frequency (Hz) [orRate (pps)] | 105.5Hz | 110Hz | From 1Hz to 150Hz | |
| 32. | Net Charge (μC per pulse) | 0μC @500Ω (Method: Balanced waveform) or 9.6μC@500Ω | 0μC @500Ω, Method: Balanced waveform | 0μC @500Ω (Method: Balanced waveform) ormaximum 10.01μC @500Ω | |
| 33. | Burst Mode | Yes | Yes | Yes | |
| 34. | Maximum Phase Charge, (µC) | 19.04μC@500Ω | 16.8μC @500Ω | 20.02μC @500Ω | |
| 35. | Maximum Average Current,(mA) | 1.004mA | 0.924mA | 3.0375mA | |
| 36. | Maximum Current Density,(mA/cm², r.m.s.) | 0.11mA/cm² @500Ω (Smallest electrode area 19cm²) | 0.462mA/cm² (Smallest electrode area 4cm²) | 0.066mA/cm² | |
| 37. | Maximum Average Power | 2.52mW/cm² @500Ω (Smallest electrode area 19cm²) | 9.702mW/cm² (Smallest electrode area 4cm²) | 2.66mW/cm² | |
| Density, (W/cm²) | |||||
| 38. | Battery charge | The Lithium battery can be recharged through bothAC adaptor and computer USB input. | The Lithium battery can be recharged through bothAC adaptor and computer USB input. | The Lithium battery can be recharged through bothAC adaptor and computer USB input. | |
| 39. | Compliance with VoluntaryStandards? | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC60601-1-11, IEC 62133, FCC 47 CFR Part15,ISO10993-5, ISO10993-10, AAMI TIR 69: 2017,ANSI C63.27: 2017 | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10,IEC 62133, FCC 47 CFR Part 18, IEC60601-1-6, ISO10993-5, ISO10993-10 | AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC60601-2-10, IEC 60601-1-11, IEC 60601-1-6,ISO10993-5, ISO10993-10 | |
| 40. | Compliance with 21 CFR 898? | N/A, device does not contain electrode lead wires orpatient cables. | Yes | Yes |
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Table 2 -
| Parameters | New Device | Predicate Device 1 | Predicate Device 2 | ||
|---|---|---|---|---|---|
| 1. | 510(k) Number: | K190009 | K121719 | K152852 | |
| 2. | Marketing clearance date: | May 10, 2013 | Dec 22, 2015 | ||
| 3. | Device Name | SM9180L&SM9180S | SM TENS & PMS | ALEVE Direct Therapy TENS Device | |
| 4. | Manufacturer | Hong Qiangxing (Shenzhen) Electronics Limited | Hong Qiangxing (Shenzhen) Electronics Limited | Bayer HealthCare LLC, Consumer Care | |
| 5. | Product code | NUH, NGX | NGX, NUH | NUH | |
| 6. | Accessories | Self-adhesive electrodes, Battery charger, USB cable,Remote control with CR2032 battery or AAA alkaline batteries | Self-adhesive electrodes, electrode wires,Battery charger, USB cable | #0 Phillips head screwdriver, Remotecontrol withCR2032 battery, AAA alkaline batteries,Hydrogel Gel Pad | |
| 7. | Intended use | TENS (Mode 1, 3, 4, 5, 6): | TENS (Mode 1, 3, 4, 5, 6): | Temporary relief of pain associated with sore and | |
| To be used for temporary relief of pain associatedwith sore and aching muscles in shoulder, back due tostrain from exercise or normal household workactivities.PMS (Mode 1, 2, 3, 4, 5, 6):It is intended to be used to stimulate healthy muscles inorder to improve and facilitate muscle performance. | To be used for temporary relief of painassociated with sore and aching muscles in theshoulder, waist, back, neck, upper extremities(arm), and lower extremities (leg) due to strainfrom exercise or normal household workactivities.PMS (Mode 1, 2, 3, 6):It is intended to be used to stimulate healthymuscles in order to improve and facilitatemuscle performance. | aching muscles in the lower back due to strainfrom exercise or normal household and workactivities. | |||
| 8. | Patient Population | Adult | Adult | Adult | |
| 9. | Prescriptive or OTC | OTC | OTC | OTC | |
| 10. | Wireless Control | Yes(Wireless device controlled by remote control) | No | Yes(Wireless device controlled by remote control) | |
| 11. | Number of Output Modes | 6 | 6 | 1 | |
| 12. | Number of Output channels: | 1 | 2 | 1 | |
| - Synchronous orAlternating? | NA | Synchronous | N/A | ||
| - Method of ChannelIsolation | NA | Voltage transformer Isolation | N/A | ||
| 13. | Power Source(s) | 3.7V rechargeable lithium battery (TENS device) 2AAA 1.5V DC batteries or 1 Lithium coin battery3.0v DC (wireless remote) | 3.7V rechargeable lithium battery | 2 AAA 1.5v DC batteries (TENS device)1 Lithium coin battery 3.0v DC (wireless remote) | |
| - Method of Line CurrentIsolation | Type BF | Type BF | Not publicly available | ||
| - Patient Leakage Current | -- | -- | -- | ||
| - Normal Condition (μΑ) | < 10μΑ | < 10μΑ | Not publicly available | ||
| - Single Fault Condition(μΑ) | < 50μA | < 50μA | |||
| 14. | Average DC current through electrodes when device is on but no pulses are being applied (µA) | <0.01µA | <0.01µA | Not publicly available | |
| 15. | Regulated Current or Regulated Voltage? | Voltage control | Voltage control | Voltage control | |
| 16. | Indicator | On/Off Status? | Yes | Yes | Yes |
| Display: | Low Battery? | No | Yes | Yes | |
| Voltage/Current Level? | Yes | No | Yes | ||
| 17. | Software/Firmware/Microprocessor Control? | Yes | Yes | Yes | |
| 18. | Automatic Overload Trip? | No | No | No | |
| 19. | Automatic No-Load Trip? | No | No | No | |
| 20. | Automatic Shut Off? | Yes | Yes | Yes | |
| 21. | User Override Control? | Yes | Yes | Yes | |
| 22. | Compliance with 21 CFR 898? | N/A, device does not contain electrode lead wires or patient cables. | Yes | N/A, device does not contain electrode lead wires patient cables. | |
| 23. | Weight (grams) | 95g | 140g | 4.8 oz.w/ batteries included | |
| 24. | Dimensions (mm) [W x H x D] | 196.89015.9mm | 83429mm | 7.5 (w) x 3.5 (h) x 0.7 in (d) | |
| 25. | Housing Materials & Construction | ABS | ABS | plastic enclosure (Housing)Integral silicone electrodes with conductive (carbon rubber) area and non-conductive area with ultramarine blue colorant (CAS # 57455-37-5) | |
| 26. | Maximum Output Voltage (volts) | 47.6V±10% @500Ω104V±10% @2kΩ157V±10% @10kΩ | 42V±10% @500Ω84V±10% @2kΩ130V±10% @10kΩ | Not publicly available | |
| 27. | Maximum Output Current | 95.2mA±10% @500Ω | 84mA±10% @500Ω | Not publicly available | |
| (specify units) | 52mA±10% @2kΩ | 42mA±10% @2kΩ | |||
| 15.7mA±10% @10kΩ | 13mA±10% @10kΩ | ||||
| 28. | Pulse width (usec) | 100μs | 100μs | Not publicly available | |
| 29. | Pulse Period (msec) | 9.5~855ms | 9.3~850ms | Not publicly available | |
| 30. | Max. pulse frequency (Hz) [orRate (pps)] | 105.5Hz | 110Hz | Not publicly available | |
| 31. | Maximum Phase Charge, (µC) | 19.04μC@500Ω | 16.8μC @500Ω | Not publicly available | |
| 32. | Maximum Average Current,(mA) | 1.004mA | 0.924mA | Not publicly available | |
| 33. | Waveform (e.g. pulsedmonophasic, biphasic) | Biphasic rectangularMonophasic rectangular | Biphasic rectangular | Not publicly available | |
| 34. | Net Charge (µC per pulse) | 0μC @500Ω (Method: Balanced waveform) or 9.6μC@500Ω | 0μC @500Ω; Method: Balanced waveform | Not publicly available | |
| 35. | Timer Range (minutes) | Nonadjustable20min | 10 ~ 60 minutes, 10 min/step | Nonadjustable30 minutes 42 seconds | |
| 36. | Burst Mode | Yes | Yes | Not publicly available | |
| 37. | Maximum Current Density,(mA/cm², r.m.s.) | 0.04mA/cm² @500Ω (Smallest electrode area 57cm²) | 0.462mA/cm² (Smallest electrode area 4cm²) | 0.056mA/cm² @500Ω (Smallest electrode area114cm²) | |
| 38. | Maximum Average PowerDensity, (W/cm²) | 0.84mW/cm² @500Ω (Smallest electrode area57cm²) | 9.702mW/cm² (Smallest electrode area 4cm²) | 1.53mW/cm² @500Ω (Smallest electrode area114cm²) | |
| 39. | Compliance with VoluntaryStandards? | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC60601-1-11, IEC 62133, FCC 47 CFR Part15,ISO10993-5, ISO10993-10, AAMI TIR 69: 2017, ANSIC63.27: 2017 | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10,IEC 62133, IEC 60601-1-6, FCC 47 CFR Part18, ISO10993-5, ISO10993-10 | • AAMI ANSI ES60601-1:2005/(R)2012And A1:2012IEC 60601-1-2 Edition 2014-02• IEC 60601-1-11 Edition 1.0 2010-04• IEC 60601-2-10 Edition 1.0 2012-06• AAMI/ANSI/ISO 10993-5:2009(R)2014AAMI/ANSI/ISO 10993-10:2010 |
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4. Safety and Effectiveness of the device:
Sunmas TENS & PMS is safe and effective as the predicate devices cited above. The new device has passed testing according to the safety standards:
ANSI AAMI ES60601-1: 2005/(R)2012 And A1:2012, C1:2009/(R)2012 And 1)
A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General
Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD);
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- IEC 60601-2-10 Edition 2.1 2016-04. Medical Electrical Equipment - Part 2-10: Particular Requirements
For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators;
- IEC 60601-2-10 Edition 2.1 2016-04. Medical Electrical Equipment - Part 2-10: Particular Requirements
ANSI AAMI IEC 60601-1-2:2014, Medical Electrical Equipment -- Part 1-2: General 3)
Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests;
- IEC 62133 Edition 2.0 2012-12, IEC 62133 Edition 2.0 2012-12 Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications [Including: Corrigendum 1 (2013)]
IEC 60601-1-11 Edition 2.0 2015-01, Medical Electrical Equipment - Part 1-11: General 5) Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment . (General II (ES/EMC))
-
FCC 47 CFR Part 15 RADIO FREQUENCY DEVICES;
-
AAMI TIR69: 2017 Technical Information Report Risk Management Of Radio-Frequency Wireless Coexistence For Medical Devices And Systems;
-
ANSI IEEE C63.27-2017 American National Standard For Evaluation Of WirelessCoexistence.
The conclusion drawn from the safety testing is that the new device is substantially equivalent to the predicate device. Furthermore, the new device complies with the recognized standards and performs its intended tasks as well as the legally marketed 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).