(90 days)
TENS (Transcutaneous Electric Nerve Stimulation):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS (Powered Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
TENS and Muscle Stimulator is a portable and DC 3.7V battery powered multifunction device, offering both Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS) qualities in one device.
TENS and Muscle Stimulator can give certain electrical pulses through electrode adhesive pads to the suggested area of the body where the electrodes are placed. AS8012 has 20 operation programs and AS8015 has 24 operation programs.
The electronic stimulatory module has the operating elements of an On/Off Switch, LCD display screen, Intensity buttons, Output channel buttons, T button, Output ports, and USB port for battery charging,etc.
The LCD display screen can show time remaining of an application program, battery power, program icons, output channel and intensity,etc.
The device is equipped with accessories of electrode pads, electrode cables a battery charger, and one USB cable. The electrode cables are used to connect the pads to the device; the USB cable is used to connect the charge and the built-in lithium battery. All accessories, including USB cables, electrode pads, electrode cables, chargers can only be changed or replaced by a qualified person.
The provided text is a 510(k) summary for a TENS and Muscle Stimulator device. It details the device's technical specifications and compares them to two predicate devices to demonstrate substantial equivalence, rather than providing a study proving a device meets specific acceptance criteria.
As such, the document does not contain information about the acceptance criteria and the study that proves the device meets those criteria in the way typically required for AI/ML-based medical devices or diagnostic devices that require performance evaluation against clinical ground truth.
The provided text focuses on electrical safety and performance standards for a TENS and Muscle Stimulator, which are typically assessed through bench testing, not clinical studies with "acceptance criteria" related to diagnostic accuracy, sensitivity, specificity, etc., or human reader improvement with AI assistance.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and the reported device performance: This document lists technical specifications and compliance with electrical safety standards, not diagnostic performance metrics.
- Sample size used for the test set and the data provenance: Not applicable here, as it's not a performance study on a test set of patient data.
- Number of experts used to establish the ground truth and qualifications: Not applicable.
- Adjudication method for the test set: Not applicable.
- MRMC comparative effectiveness study or effect size: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable (not an AI/ML device in the context of this document).
- How the ground truth for the training set was established: Not applicable.
What the document does provide in terms of "acceptance":
The document demonstrates that the new device meets electrical safety and performance standards the FDA considers essential for this type of device to be "substantially equivalent" to legally marketed predicate devices. The "acceptance criteria" in this context are primarily the successful completion of tests according to the following voluntary standards:
- 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 60601-1:2005, MOD): General safety requirements.
- 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: Specific safety and performance requirements for 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: Requirements for electromagnetic compatibility.
- IEC 62133-2 Edition1.0 2017-02 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 - Part 2: Lithium Systems: Battery safety.
- 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: Requirements for home healthcare use.
The statement "The conclusion drawn from the safety testing is that the new devices are substantially equivalent to the predicate devices. Furthermore, the new devices comply with the recognized standards and perform its intended tasks as well as the legally marketed predicate devices." serves as the proof of compliance with these "acceptance criteria" (i.e., meeting the requirements of the cited standards).
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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.
June 18, 2020
Shenzhen As Tec Technology Co., Ltd % Doris Dong Manager Shanghai CV Technology Co., Ltd Room 903, No. 19 Dongbao Road, Songjiang Area Shanghai, China 201613
Re: K200727
Trade/Device Name: TENS and Muscle Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: March 10, 2020 Received: March 20, 2020
Dear Ms. 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/cfpmr/pmn.cfm identifies combination product submissions. The general controls provisions of the Actinclude 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
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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-devices/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 (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200727
Device Name
TENS and Muscle Stimulator (Model AS8012 & AS8015)
Indications for Use (Describe)
TENS (Transcutaneous Electric Nerve Stimulation):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS (Powered Muscle Stimulation):
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) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
_ | 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: | K200727 |
|---|---|
| Date: | December 27, 2019 |
| Type of 510(k) Submission: | Traditional |
| Basis for 510(k) Submission: | New device |
| Submitter/Manufacturer: | Shenzhen As-Tec Technology Co., Ltd. |
| 8E XinBaoYi Industrial Bld, Houting Village Beiting Road, ShajingShenzhen Guangdong, CHINA 518012 | |
| 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: | TENS and Muscle Stimulator (Model AS8012, AS8015) |
| 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: | TENS and Muscle Stimulator is a portable and DC 3.7V battery powered multifunction device, offering both Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS) qualities in one device.TENS and Muscle Stimulator can give certain electrical pulses through electrode adhesive pads to the suggested area of the body where the electrodes are placed. AS8012 has 20 operation programs and AS8015 has 24 operation programs.The electronic stimulatory module has the operating elements of an On/Off Switch, LCD display screen, Intensity buttons, Output channel buttons, T button, Output ports, and USB port for battery charging,etc.The LCD display screen can show time remaining of an application program, battery power, program icons, output channel and intensity,etc.The device is equipped with accessories of electrode pads, electrode cables a battery charger, and one USB cable. The electrode cables are used to connect the pads to the device; the USB cable is used to connect the charge and the built-in lithium battery. All accessories, including USB cables, |
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| electrode pads, electrode cables, chargers can only be changed or replacedby a qualified person. | |
|---|---|
| Indications for use: | TENS ( Transcutaneous Electric Nerve Stimulation ):To be used for temporary relief of pain associated with sore and achingmuscles in the shoulder, waist, back, upper extremities (arm), and lowerextremities (leg) due to strain from exercise or normal household workactivities. |
| PMS ( Powered Muscle Stimulation ): |
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:
Detailed comparison data is included in "Section 10.1 - Substantial Equivalence Discussion" of this 510(k) submission.
Table 1 -
| Parameters | New Device | Predicate Device | Same/Different | ||
|---|---|---|---|---|---|
| 1. | 510(k) Number | Unassigned | K143268 | ||
| 2. | Marketing clearancedate | / | 07/21/2015 | ||
| 3. | Device Name | TENS and MuscleStimulator | TENS AND POWEREDMUSCLE STIMULATOR | ||
| 4. | Model | AS8012 | N/A | ||
| 5. | Manufacturer | Shenzhen As-TecTechnology Co., Ltd. | Shenzhen As-TecTechnology Co., Ltd. | SE | |
| 6. | Intended use | TENS (Program 3, 4, 8,9,12, 13, 14, 15, 17, 18, 19,20):To be used for temporaryrelief of pain associated withsore and aching muscles inthe shoulder, waist, back,upper extremities (arm), andlower extremities (leg) dueto strain from exercise ornormal household workactivities.PMS (Program 1, 2, 5, 6, 7,10, 11, 16):It is intended to be used tostimulate healthy muscles inorder to improve andfacilitate muscleperformance. | TENS (Mode 1, 3, 4, 5, 6):To be used for temporaryrelief of pain associated withsore and aching muscles inthe shoulder, waist, back,upper extremities (arm), andlower extremities (leg) dueto strain from exercise ornormal household workactivities.PMS (Mode 1, 2, 3, 5):It is intended to be used tostimulate healthy muscles inorder to improve andfacilitate muscleperformance. | SameNote 1 | |
| 7. | Type of use | OTC | OTC | Same | |
| 7.8 | Power Source(s) | DC 3.7V lithium battery | DC 3.7V lithium battery | Same | |
| - Method of LineCurrent Isolation | Type BF | Type BF | Same | ||
| - Patient LeakageCurrent | -- | -- | Same | ||
| - NormalCondition (μΑ) | 0.1μΑ | 0.1μΑ | |||
| - Single FaultCondition (μΑ) | 0.1μΑ | 0.1μΑ | |||
| 9. | Average DC currentthrough electrodeswhen device is on | < 0.01μΑ | < 0.01μΑ | Same | |
| 8E XinBao Y1 Industrial Bld, Houting Village Beiting Road, Shajing Shenzhen Guangdong, CHINA 518012but no pulses are being applied (µA) | |||||
| 10. | Number of Output Modes | 20 | 6 | SameNote 1 | |
| 11. | Number of Output channels: | 2 | 2 | Same | |
| - Synchronous or Alternating? | Alternating | Synchronous | SameNote 2 | ||
| - Method of Channel Isolation | Voltage transformerIsolation | Voltage transformerIsolation | Same | ||
| 12. | Regulated Current or Regulated Voltage? | Voltage control | Voltage control | Same | |
| 13. | Software/Firmware/Microprocessor Control? | Software | Software | Same | |
| 14. | Automatic Overload Trip? | No | No | Same | |
| 15. | Automatic No-Load Trip? | Yes | No | SameNote 2 | |
| 16. | Automatic Shut Off? | Yes | Yes | Same | |
| 17. | User Override Control? | Yes | Yes | Same | |
| 18. | Indicator Display | On/Off Status? | Yes | Yes | Same |
| Low Battery? | Yes | Yes | Same | ||
| Voltage/ Current Level? | Yes | Yes | Same | ||
| 19. | Timer Range (minutes) | 10 ~ 60 minutes, 10 min/step | 10 ~ 60 minutes, 10 min/step | Same | |
| 20. | Compliance with Voluntary Standards? | Yes.AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 62133, IEC 60601-1-11 | Yes.AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 62133, IEC 60601-1-11 | Same | |
| 21. | Compliance with 21 CFR 8988? | Yes | Yes | Same | |
| 22. | Weight (grams) | 72g | 170g | Same | |
| 23. | Dimensions (mm) [W x H x D] | 55.410312mm | 93509mm | SameNote 1 | |
| 24. | Housing Materials & Construction | ABS+Stainless iron | ABS | Same | |
| 25. | Waveform | Pulsed, symmetric, biphasic | Pulsed, symmetric, biphasic | Same | |
| 26. | Shape | Rectangular, with interphase interval | Rectangular, with interphase interval | Same | |
| 27. | Maximum OutputVoltage (volts) | $49.6V±20% @500Ω$$90V±20% @2kΩ$$120V±20% @10kΩ$ | $53.5V±20% @500Ω$$67V±20% @2kΩ$$68V±20% @10kΩ$ | SameNote 3 | |
| 28. | Maximum OutputCurrent (specifyunits) | $99.2mA±20% @500Ω$$45mA±20% @2kΩ$$12mA±20% @10kΩ$ | $107mA±20% @500Ω$$33.5mA±20% @2kΩ$$6.8±20% @10kΩ$ | ||
| 29. | Pulse width (µsec) | Positive phase: 80µs±10%Negative phase: 80µs±10%Interphase interval: 80µs±10% | Positive phase: 225µsNegative phase: 225µsInterphase interval: 225µs | ||
| 30. | Pulse Period (msec) | 10-1000ms | 8.9~617ms | ||
| 31. | Pulse frequency(Hz) [or Rate (pps)] | 1-100Hz±10% | 1.62Hz~113Hz | ||
| 32. | Net Charge (µC perpulse) | $0μC @500Ω$ ; Method:Balanced waveform | $0μC @500Ω$ ; Method:Balanced waveform | Same | |
| 33. | Maximum PhaseCharge, (µC) | $15.87μC@500Ω$ | $48μC @500Ω$ | SameNote 4 | |
| 34. | Maximum AverageCurrent, (mA) | $0.793mA@500Ω$ | $2.72mA @500Ω$ | ||
| 35. | Maximum CurrentDensity, (mA/cm²,r.m.s.) | 0.06mA/cm² @500Ω(Smallest electrode area 25cm²) | 1.36mA/cm² (Smallest electrode area 4cm²) | ||
| 36. | Maximum AveragePower Density,(mW/cm²) | 1.57mW/cm² @500Ω(Smallest electrode area 25cm²) | 36.4mW/cm² (Smallest electrode area 4cm²) | ||
| 37. | Battery charge | ① The Lithium battery canbe recharged through bothAC adaptor and computerUSB input.② When charging isfinished, the LCD will showfull cell of battery. | ① The Lithium battery canbe recharged through bothAC adaptor and computerUSB input.② When charging isfinished, the LCD will showfull cell of battery. | Same | |
| 38. | Accessories | Self-adhesive electrodes,electrode wires, Batterycharger, USB cable | Self-adhesive electrodes,electrode wires, Batterycharger, USB cable | Same |
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Shenzhen As-Tec Technology Co., Ltd.
8E XinBaoYi Industrial Bld, Houting Village Beiting Road, Shajing Shenzhen Guangdong, CHINA 518012
{7}------------------------------------------------
Shenzhen As-Tec Technology Co., Ltd.
8E XinBaoYi Industrial Bld Houting Village Beiti
Differences between proposed device and predicate device:
Note 1:
The proposed device AS8012 has more treatment programs than the predicate device K143268, but all of the treatment programs have passed the IEC 60601-2-10 test codes. So this difference doesn't raise any safety or effectiveness issue. And the weight, dimensions, housing material, appearance of proposed device AS8012 are a little different from predicate device K143268. Consider the same intended use, components, working principle, test standards, these differences are insignificant in the terms of safety or effectiveness.
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Note 2:
The output two channels of the proposed device is alternating while the predicate device is synchronous. Because the proposed device and predicate device adopt the same fundamental output technology and similar treatment effect. Therefore, this item is considered to be substantially equivalent. The proposed device has automatic no-Load trip function and the predicate device doesn't have. This function makes the proposed device has no output current when it is not connected to the human body. It is a safety protection function so this difference doesn't raise any new safety and effectiveness issues. Also, the proposed device had passed AAMI / ANSI ES60601-2-10 test codes, so these differences don't raise any new safety and effectiveness issues.
Note 3:
There are some differences on the maximum output voltage, maximum output current, pulse width, frequency, pulse width between proposed device and predicate device. Based on the calculation of maximum current density, maximum average power density, these parameters don't exceed the safety limit. And these parameters have passed IEC 60601-2-10 test codes. So these differences don't raise any new safety and effectiveness issues.
Note 4:
The maximum phase charge of the proposed device (15.87uC@500Ω) is less than the predicate device (48uC @5002), but the cleared device K121719, which is the predicate device of K143268, has the maximum phase charge of 16.8uC@5002. The value of the proposed device is similar to that of the 510K clearance device K121719, therefore this difference doesn't raise any new safety and effectiveness issues.
The maximum average current, maximum current density, maximum average power density have some differences between proposed device and predicate device due to they are calculated by different electrode area. Both of them meet maximum current density <2mA/cm2 and maximum average power density <0.25W/cm². Therefore these differences don't raise any new safety and effectiveness issues.
The burst mode, on time and off time between proposed device and predicate device are little different. Because each program of proposed device is compared to the predicate's modes, and they adopt similar treatment effect. The TENS programs of proposed device are compared to the predicate's TENS modes, the PMS programs of proposed device are compared to the predicate's PMS modes. Also, all programs have passed AAMI/ANSI ES 60601-1 and IEC 60601-2-10 test codes. Therefore these differences don't raise any new safety and effectiveness issues.
Detailed comparison data is included in "Section 10.2 - Substantial Equivalence Discussion" of this 510(k) submission.
Table 2 -
| Parameters | New Device | Predicate Device | Same/Different | |
|---|---|---|---|---|
| 1. | 510(k) Number | Unassigned | K190115 | |
| 2. | Marketing clearance date | / | 06/19/2019 | |
| 3. | Device Name | TENS AND POWERED MUSCLE STIMULATOR | MHD TENS | |
| 4. | Model | AS8015 | MH-1085 | |
| 5. | Manufacturer | Shenzhen As-Tec Technology Co., | MingHuangDa |
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| Shenzhen As-Tec Technology Co., Ltd. |
|---|
| 8E XinBaoYi Industrial Bld, Houting Village Beiting Road, Shajing Shenzhen Guangdong, CHINA 518012 |
| Ltd. | Electronic Co.,Ltd | ||||
|---|---|---|---|---|---|
| 6. | Intended use | TENS (Program 1, 4, 7, 10, 14, 15, 20, 23, 24):To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.PMS (Program 2, 3, 5, 6, 8, 9, 11, 12, 13, 16, 17, 18, 19, 21, 22):It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. | TENS (Program 2, 3, 4, 6, 8, 9):To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.PMS (Program 1, 5, 7, 10, 11, 12):It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. | SameNote 1 | |
| 7. | Type of use | OTC | OTC | Same | |
| 8. | Power Source(s) | DC 3.7V lithium battery | DC 3.7V lithium battery | Same | |
| - Method of Line Current Isolation | Type BF | Type BF | Same | ||
| - Patient Leakage Current | -- | -- | Same | ||
| - Normal Condition (μΑ) | < 10μΑ | < 10μΑ | |||
| - Single Fault Condition (μΑ) | < 50μΑ | < 50μΑ | |||
| 9. | Average DC current through electrodes when device is on but no pulses are being applied (µA) | < 0.01μΑ | < 0.01 μΑ | Same | |
| 10. | Number of Output Modes | 24 | 12 | SameNote 1 | |
| 10. | Number of Output channels: | 2 | 2 | Same | |
| - Synchronous | Alternating | Alternating | Same | ||
| or Alternating? | |||||
| - Method of Channel Isolation | Voltage transformer Isolation | Voltage transformer Isolation | Same | ||
| 12. | Regulated Current or Regulated Voltage? | Regulated Voltage | Regulated current | Same | |
| 13. | Software/Firmware /Microprocessor Control? | Software | Software | Same | |
| 14. | Automatic Overload Trip? | No | No | Same | |
| 15. | Automatic No-Load Trip? | Yes | No | SameNote 2 | |
| 16. | Automatic Shut Off? | Yes | Yes | Same | |
| 17. | User Override Control? | Yes | Yes | Same | |
| 17. | Indicator Display | On/Off StatusLow BatteryVoltage /Current Level | Yes | Yes | Same |
| 19. | Timer Range (minutes) | $10 ~ 60$ minutes, 10 min/step | $10 ~ 60$ minutes, 10 min/step | Same | |
| 20. | Compliance with Voluntary Standards? | Yes.AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 62133, IEC 60601-1-11 | Yes.AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 62133, IEC 60601-1-11 | Same | |
| 21. | Compliance with 21 CFR 8988? | Yes | Yes | Same | |
| 22. | Weight (grams) | 110g | 110g | Same | |
| 23. | Dimensions (mm) [W x H x D] | 66.1129.211mm | 132.865.813.8mm | SameNote 1 | |
| 24. | Housing Materials & Construction | ABS+aluminium alloy | ABS+aluminium alloy | Same | |
| 25. | Waveform | Pulsed, symmetric, biphasic | Pulsed, symmetric, biphasic | Same | |
| 26. | Shape | Rectangular, with interphase interval | Rectangular, with interphase interval | Same | |
| 26. | Maximum Output | 63V±15% @500Ω | 78V±15% @500Ω | Same | |
| Voltage (volts) | $110V±15% @2kΩ$ | $153V±15% @2kΩ$ | Note 3 | ||
| $136V±15% @10kΩ$ | $161V±15% @10kΩ$ | ||||
| 27.Maximum Output | $126mA±15% @500Ω$ | $156mA±15% @500Ω$ | |||
| Current (specify | $55mA±15% @2kΩ$ | $76.5mA±15% @2kΩ$ | |||
| units) | $13.6mA±15% @10kΩ$ | $16.1mA±15% @10kΩ$ | |||
| 29. | Pulse width (usec) | Positive phase: $100µs±10%$ | Positive phase:$78μs±10%$ | ||
| Negative phase: $100µs±10%$ | Negative phase:$78μs±10%$ | ||||
| Interphase interval: $100µs±10%$ | Interphase interval:$70μs±10%$ | ||||
| 30. | Pulse Period(msec) | 7.6-833ms | 14.3~1000ms | ||
| 31. | Max. pulsefrequency (Hz) [orRate (pps)] | 1.2-132Hz±10% | 1~70Hz | ||
| 32. | Net Charge (µC perpulse) | $0μC @500Ω$ ; Method: Balancedwaveform | $0μC @500Ω$ ; Method:Balanced waveform | Same | |
| 33. | Maximum PhaseCharge, (µC) | $25.2μC@500Ω$ | $24.3μC@500Ω$ | SameNote 4 | |
| 34. | Maximum AverageCurrent, (mA) | $1.67mA@500Ω$ | $0.852mA@500Ω$ | ||
| 35. | Maximum CurrentDensity, (mA/cm²,r.m.s.) | $0.13mA/cm² @500Ω$ (Smallestelectrode area 25cm²) | $0.142mA/cm² @500Ω$ (Smallestelectrode area 12cm²) | ||
| 36. | Maximum AveragePower Density,(mW/cm²) | $4.19mW/cm² @500Ω$ (Smallestelectrode area 25cm²) | $5.54mW/cm² @500Ω$(Smallest electrodearea 12cm²) | ||
| 37. | Battery charge | ① The Lithium battery can berecharged through both AC adaptorand computer USB input.② When charging is finished, theLCD will show full cell of battery. | ① The Lithium batterycan be rechargedthrough both ACadaptor and computerUSB input.② When charging isfinished, the LCD willshow full cell ofbattery. | Same | |
| 38. | Accessories | Self-adhesive electrodes, electrodewires, Battery charger, USB cable | Self-adhesiveelectrodes, electrodewires, Battery charger,USB cable, Screenstylus | SameNote 1 |
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Shenzhen As-Tec Technology Co., Ltd.
8E XinBaoYi Industrial Bld, Houting Village Beiting Road, Shajing Shenzhen Guangdong, CHINA 518012
Differences between proposed device and predicate device:
Note 1:
The proposed device AS8015 has more treatment programs than the predicate device K190115, but all of the
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Shenzhen As-Tec Technology Co., Ltd.
8E XinBaoYi Industrial Bld, Houting Village Beiting Road, Shajing Shenzhen Guangdong, CHINA 518012
treatment programs have passed the IEC 60601-2-10 test codes. So this difference will not raise any safety or effectiveness issue. And the dimensions, appearance of proposed device AS8015 are a little different from predicate device K190115. Consider the same intended use, components, working principle, test standards, these differences are insignificant in the terms of safety or effectiveness. The accessories of AS8015 are a little different from K190115 because AS8015 doesn't have screen stylus. Both of them are touchable LCD, the screen stylus can be replaced by fingers. So this difference doesn't affect the product functionally or raise any safety and effectiveness issues.
Note 2:
The proposed device has automatic no-Load trip function and the predicate device doesn't have. This function makes the proposed device has no output current when it is not connected to the human body. It is a safety protection function so this difference doesn't raise any new safety and effectiveness issues. Also, the proposed device had passed AAMI / ANSI ES60601-1 and IEC 60601-2-10 test codes, so this difference doesn't raise any new safety and effectiveness issues.
Note 3:
There are some differences on the maximum output voltage, maximum output current, pulse width, frequency, pulse width between proposed device and predicate device. Based on the calculation of maximum current density, maximum average power density, these parameters don't exceed the safety limit. And these parameters have passed IEC 60601-2-10 test codes. So these differences don't raise any new safety and effectiveness issues.
Note 4:
The maximum phase charge of the proposed device (25.2μC@500Ω) is very similar to the predicate device (24.3μC(@500Ω), therefore this difference won't raise any new safety and effectiveness issues.
The maximum average current, maximum current density, maximum average power density have some differences between proposed device and predicate device due to they are calculated by different electrode area. Both of them meet maximum current density <2mA/cm² and maximum average power density <0.25W/cm². Therefore these differences don't raise any new safety and effectiveness issues.
The burst mode, on time and off time between proposed device and predicate device are little different. Because each program of proposed device is compared to the predicate's programs, and they adopt similar treatment effect. The TENS programs of proposed device are compared to the predicate's TENS programs, PMS programs are compared to the predicate's PMS programs. Also, all programs have passed AAMI/ANSI ES 60601-1 and IEC 60601-2-10 test codes. Therefore these differences don't raise any new safety and effectiveness issues.
4. Safety and Effectiveness of the device:
TENS and Muscle Stimulator (AS8012, AS8015) are safe and effective as the predicate devices cited above. The new devices have passed testing according to the safety standards:
- 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 60601-1:2005, MOD);
- 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;
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8E XinBaoYi Industrial Bld, Houting Village Beiting Road, Shajing Shenzhen Guangdong, CHINA 518012
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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;
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IEC 62133-2 Edition1.0 2017-02 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 - Part 2: Lithium Systems
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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 . (General II (ES/EMC))
The conclusion drawn from the safety testing is that the new devices are substantially equivalent to the predicate devices. Furthermore, the new devices comply with the recognized standards and perform 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).