Levator Elite (Model LE9011)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. February 25, 2022 Shenzhen Dongdixin Technology Co., Ltd. Siping Yuan R.A. Specialist Floor 1-2, No.3 Building, Fanshen Xusheng Industrial Estate Xilixiaobaimang Nanshan District Shenzhen, Guangdong 518108 China Re: K213043 Trade/Device Name: Levator Elite (Model LE9011) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF, KPI, HCC, GZJ Dated: January 20, 2022 Received: January 27, 2022 Dear Siping 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. 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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, Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213043 Device Name Levator Elite (Model LE9011) Indications for Use (Describe) NMES Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle Re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion EMG Triggered Stimulation (ETS) (nonimplanted electrical continence device only) Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detrusor muscles through reflexive mechanisms of pelvic floor muscles Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles (abdominal or gluteal) #### TENS Symptomatic relief and management of chronic (long-term), intractable pain Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain #### EMG Biofeedback, relaxation muscle training and muscle re-education 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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There are also three Chinese characters to the right of the English text. # 510(k) SUMMARY # as required by section 21 CFR 807.92 Levator Elite (Model LE9011) | Date of Submission: | 02/25/2022 | |---------------------|---------------------------------------------------------------------------------------------------------------------------------| | Submitter's Name: | Shenzhen Dongdixin Technology Co., Ltd. | | Address: | Floor 1-2, No.3 Building, Fanshen Xusheng Industrial<br>Estate Xilixiaobaimang 518108 Nanshan District,<br>Shenzhen P. R. China | | E-mail: | yuansp@dundex.com | | Tel: | +86(755) 27652471 | | FAX: | +86(755) 27652674 | | Contact: | Siping Yuan | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue, except for a diagonal line through the "X" in "DIXIN", which is in orange. To the right of the English text is the company name in Chinese characters. #### Proposed Device: 1. Proprietary Name: Levator Elite(Model LE9011) Classification Name: Stimulator, Muscle, Powered Regulation #: 21 CFR 890.5850 Panel: Physical Medicine Regulatory Class: Class II Product Code: IPF, KPI, GZJ, HCC #### 2. Predicate Device: | Predicate Device | 510(k) | Trade Name | Manufacturer | |-------------------|---------|------------------------------------------------------|-------------------------| | Predicate Device1 | K201290 | Medline DeNovo 4Pro<br>Electrical Stimulation Device | Medline Industries Inc | | Predicate Device2 | K201014 | MyOnyx System | Thought Technology Ltd. | #### 3. Device Description: Levator Elite(Model LE9011) is a single channel, hand-held, non-sterile, battery-powered, multi-patient device intended to be used by adult patients under the supervision of a trained clinical healthcare provider. The device contains EMG biofeedback, TENS (Transcutaneous Electrical Nerve Stimulation), ETS (EMG triggered stimulation) and NMES (Neuromuscular Electrical Stimulator). Each of them has pre-set and custom programs. The parameters of the device are controlled by the buttons, the levels of intensity are adjustable to the needs of the patient and treatments prescribed by their healthcare providers. The device is designed to provide safe and effective electrical stimulation by sending small electrical currents to underlying nerves and muscle groups via electrode pads applied on the skin or through a vaginal probe/rectal probe (for incontinence treatment protocols only). It can be used with or without linkage to a PC. Connecting the device with the PC via USB cable, the data can be transmitted between PC and device (It needs purchase the PC software Nu-Tek System and USB connection cable). For EMG biofeedback, EMG is for detecting the signal of muscle, which display muscle strength via EMG biofeedback bar graph or waveform format viewed on the LCD screen of the unit. Surface EMG is used for recording from superficial muscles in clinical or kinesiological protocols, where intramuscular electrodes are used for investigating deep muscles or localized muscle activity. For NMES is the elicitation of muscle contraction using electric impulses. The impulses are generated by a device and delivered through the electrodes in direct proximity to the muscles to be stimulated or via the probe. The impulses mimic the action potential coming from the central nervous system, causing the muscles to contract. NMES is both a form of electrotherapy and of muscle training. Neuromuscular Stimulation has been used to stimulate muscle and nerve fibers for muscle strengthening, maintenance of {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue, except for a diagonal line through the "X" in "DIXIN", which is in yellow. To the right of the English text is the company name in Chinese characters. muscle mass and strength during prolonged periods of immobilization, selective muscle retraining. For ETS (i.e. EMG triggered stimulation), ETS involves initiating a voluntary contraction for a specific movement until the muscle activity reaches a threshold level. As soon as the EMG activity reaches a target threshold then an assisting electrical stimulus begins which helps to support the contracted muscle. A microprocessor connected to the surface electrodes, vaginal probe or rectal probe monitors the EMG activity levels as well as administers the neuromuscular stimulation. The target threshold could be set to automated regime, when it goes up and down depending on the running muscle performance. For TENS, the device provides a non-invasive, low-risk nerve stimulation in order to reduce pain (both acute and chronic). In TENS, mild electrical impulses are transmitted through the skin via surface electrodes to relieve muscle pain by modifying the body's pain perception. TENS does not cure problematic physiological conditions: it only helps to control the pain perception. LE9011 consists of the following elements: - Main device - Pedestal - Lead wire - Electrode pad - Vaginal probe - Rectal probe (optional) - · PC Software(optional) - · USB Cable(optional) #### 4. Indications for Use: NMES - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle Re-education - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion EMG Triggered Stimulation (ETS) mode (nonimplanted electrical continence device only): - Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscles through reflexive mechanisms and strengthening of pelvic floor muscles - Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles (abdominal or gluteal) {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for DONGDIXIN Technology Co., LTD. The logo is in blue and yellow. The text "DONGDIXIN" is in large, bold, blue letters, with a yellow line crossing through the "X". Below that, the text "TECHNOLOGY CO., LTD." is in smaller, blue letters. To the right of the main text, there are three Chinese characters in blue. ### TENS - Symptomatic relief and management of chronic (long-term), intractable pain - Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain ### EMG - Biofeedback, relaxation muscle training and muscle re-education {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains a company logo. The logo consists of the text "DONGDIXIN" in a bold, dark blue font, with an orange line crossing through the "X". Below the company name, the text "TECHNOLOGY CO., LTD." is written in a smaller, dark blue font. To the right of the company name, there are three Chinese characters stacked vertically, also in dark blue. # 5. Comparison of Technological Characteristic ### Comparison of proposed device and predicate device | No. | Item | Proposed device | Primary Predicate device | Secondary Predicate<br>device | S.E. Discussion | |-----|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------| | 1 | 510K# | K213043 | K201290 | K201014 | N/A | | 2 | Device Name<br>and Model | Levator Elite(Model LE9011) | Medline DeNovo 4Pro<br>Electrical Stimulation Device | MyOnyx System | N/A | | 3 | Manufacturer | Shenzhen Dongdixin Technology<br>Co., Ltd. | Medline (Sponsor)<br>Verity (Manufacturer) | Thought Technology<br>Ltd. | N/A | | 4 | Product Code | IPF<br>KPI<br>HCC<br>GZJ | IPF<br>KPI<br>HCC<br>GZJ<br>GZI | KPI<br>HCC | Similar, the proposed<br>device does not have FES<br>function. | | 5 | Classification<br>Code | Class II | Class II | Class II | Same | | 6 | Regulation<br>Number | 21 CFR 890.5850<br>21 CFR 876.5320<br>21 CFR 882.5050<br>21 CFR 882.5890 | 21 CFR 890.5850<br>21 CFR 876.5320<br>21 CFR 882.5050<br>21 CFR 882.5890<br>21 CFR 882.5810 | 21 CFR 876.5320<br>21 CFR 882.5050 | Similar, the proposed<br>device does not have FES<br>function. | | 7 | Indications<br>for use | NMES<br>● Relaxation of muscle spasms<br>● Prevention or retardation of<br>disuse atrophy<br>● Increasing local blood<br>circulation<br>● Muscle Re-education<br>● Immediate post-surgical<br>stimulation of calf muscles to<br>prevent venous thrombosis | For EMG mode:<br>- Relaxation muscle training and<br>muscle re-education<br>For NMES (also known as STIM)<br>mode:<br>- Relaxation of muscle spasms<br>- Prevention or retardation of<br>disuse atrophy<br>- Increasing local blood | The MyOnyx System is<br>indicated for acute<br>and ongoing<br>treatment of stress,<br>urge, or mixed urinary<br>incontinence, where<br>urinary control may be<br>improved through<br>electrical stimulation<br>that strengthens the | Similar, the proposed<br>device does not have FES<br>function. | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for DONGDIXIN Technology Co., LTD. The logo is in blue, with the exception of a yellow line that crosses through the "X" in DONGDIXIN. To the right of the company name are three Chinese characters in blue. | ● Maintaining or increasing<br>range<br>of motion<br><br>EMG Triggered Stimulation (ETS)<br>(nonimplanted electrical<br>continence device only):<br>● Acute and ongoing treatment<br>of stress, urge or mixed urinary<br>incontinence and where the<br>following results may improve<br>urinary control: Inhibition of<br>the detruser muscles through<br>reflexive mechanisms and<br>strengthening of pelvic floor<br>muscles<br>● Incontinence treatment for<br>assessing EMG activity of the<br>pelvic floor and accessory<br>muscles (abdominal or gluteal)<br><br>TENS<br>● Symptomatic relief and<br>management of chronic<br>(long-term),intractable pain<br>● Adjunctive treatment in the<br>management of post-surgical<br>pain and post traumatic acute<br>pain<br><br>EMG<br>● Biofeedback, relaxation muscle | circulation<br>- Immediate post-surgical<br>stimulation of calf muscles to<br>prevent venous thrombosis<br>- Maintaining or increasing<br>range of motion<br>- Muscle Re-Education<br><br>For TENS mode:<br>- Symptomatic relief and<br>management of chronic<br>(long-term), intractable pain<br>- Adjunctive treatment in the<br>management of post-surgical<br>pain and post traumatic acute<br>pain<br><br>For EMG Triggered Stimulation<br>(ETS) mode (nonimplanted<br>electrical continence device<br>only):<br>-Acute and ongoing treatment<br>of stress, urge or mixed urinary<br>incontinence and where the<br>following results may improve<br>urinary control: Inhibition of the<br>detruser muscles through<br>reflexive mechanisms and<br>strengthening of pelvic floor<br>muscles<br>-Incontinence treatment for<br>assessing EMG activity of the | pelvic floor muscles or<br>inhibits the detrusor<br>muscle through<br>reflexive mechanisms.<br>The system also uses<br>EMG-based or<br>pressure-based<br>biofeedback to help<br>control and<br>strengthen the pelvic<br>floor muscles in the<br>treatment of urinary<br>incontinence. | 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{9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for DONGDIXIN Technology Co., LTD. The logo is in blue, with the letters "DONGDIXIN" in a large, bold font. There is an orange line going through the "X" in DONGDIXIN. Below the company name is the text "TECHNOLOGY CO., LTD." in a smaller font. To the right of the company name are three Chinese characters. | | | training and muscle re-education | pelvic floor and accessory<br>muscles (abdominal or gluteal) | | | | |-----------------------------------------------|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | | | | For FES<br>- Helps to relearn voluntary<br>motor functions of the<br>extremities | | | | | 8 | Prescription vs.<br>OTC | Prescription Use | Prescription Use | Prescription Use | Same | | | 9 | Sterile<br>vs.<br>Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Same | | | 10 | Waveforms | Symmetrical Biphasic | ● Symmetrical Biphasic DC<br>zero[TENS and HAN (TENS)]<br>● Symmetrical Biphasic [NMES] | Symmetrical,<br>rectangular, bipolar,<br>biphasic | Same | | | 11 | Target<br>Population | Adult | Adult | Adult | Same | | | 12 | Power Source | DC 6V, 4*AA batteries | 4x AA NiMh 4.8V Rechargeable<br>Battery pack | Internal Battery (not<br>user replaceable):<br>Rechargeable<br>(3200mAh) Li-ion<br>Polymer battery<br>certified to IEC 62133<br>- up to 8 hours of<br>autonomous device<br>operation; External<br>15W, 5V Medical<br>Grade<br>(Class II Double<br>Insulated) Power<br>Supply /Battery<br>Charger | Different, but the proposed<br>device has passed the<br>testing according to the<br>requirement of IEC60601-1.<br>The difference does not<br>raise any safety issue. | | | 13 | Electrical Type | Type BF | Type BF | Type BF | Same | | | 14 | Patient Leakage<br>Current (μΑ)<br>-Normal<br>condition | 1uA | N/A<br>Battery Operated Device (<100<br>µA patient leakage) | / | Different, but the proposed<br>device has passed the<br>testing according to the<br>requirement of IEC60601-1.<br>The difference does not<br>raise any safety issue. | | | 15 | Patient Leakage<br>Current (μΑ)<br>-Single fault<br>condition | N/A | N/A<br>Battery Operated Device (<100<br>µA patient leakage) | / | Same | | | 16 | Number of<br>Output Modes | Two<br>● Muscle stimulator: Electrodes<br>● TENS (Transcutaneous electrical<br>nerve stimulator): Electrodes | Two<br>● Muscle stimulator: Electrodes<br>● TENS (Transcutaneous<br>electrical nerve stimulator):<br>Electrodes | One<br>● Muscle stimulator:<br>Electrodes | Same with primary<br>predicate device. | | | 17 | Number of<br>Output<br>Channels | 1 | 4 | 4 | Different, the number of<br>output channels is the<br>feature of device, doesn't<br>affect the safety and<br>effectiveness. | | | 18 | Synchronous or<br>Alternating? | N/A, one channel | Synchronous and Alternating | / | Different, the proposed<br>device has one channel. | | | 19 | Method of<br>Channel<br>Isolation | N/A, one channel | Each channel is the middle of an<br>H bridge.<br>Each channel is in a high<br>impedance state<br>except when it is activated for a<br>specific<br>output pulse | / | | | | 20 | Regulated | Constant current | Constant current on all four | Constant current | Same | | | | Current or<br>Regulated<br>Voltage? | | channels | | | | | 21 | Software/Firmw are/<br>Micro processor<br>Control? | Yes | Yes | Yes | Same | | | 22 | Automatic<br>Overload Trip | Yes | No Device can withstand indefinite short circuit | Yes | Different, but the proposed device has passed the testing according to the requirement of IEC60601-1. The difference does not raise any safety issue. | | | 23 | Automatic No<br>Load contact<br>Trip | Yes | Yes | Yes | Same | | | 24 | Automatic Shut<br>off | Yes | Yes | Yes | Same | | | 25 | User Override<br>Control? | Yes | Yes | Yes | Same | | | 26 | Indicator<br>Display:<br>- On/Off<br>- Low Battery?<br>- Voltage/<br>Current Level? | Yes | Yes | Yes | Same | | | 27 | Compliance<br>with Voluntary<br>Standards? | Yes<br>IEC 60601-1:2005+A1:2012<br>IEC60601-1-2<br>IEC 60601-1-6<br>IEC 60601-2-10 | Yes<br>IEC 60601-1:2005+A1:2012<br>IEC60601-1-2<br>IEC 60601-1-6<br>IEC 60601-2-10 | Yes<br>IEC/ES 60601-1 (Ed.<br>3.1)<br>IEC 60601-1-6<br>IEC 60601-2-10 | Similar | | | | | | FCC PART 15 Subpart B:2008<br>Class B<br>FCC CFR Title 47 Part 15 Subpart C | IEC 60601-2-40<br>IEC 60601-1-2 (4th Ed.) | | | | 28 | Compliance<br>with 21 CFR<br>898? | Yes. leads with conductive<br>connection to a<br>patient are constructed such that<br>no<br>conductive connection remote<br>from the<br>patient can contact earth or<br>hazardous<br>voltages | Yes. leads with conductive<br>connection to a<br>patient are constructed such that<br>no<br>conductive connection remote<br>from the<br>patient can contact earth or<br>hazardous<br>voltages | Yes. | Same | | | 29 | Weight (grams.) | 158g without batteries | 160 grams (0.35 lbs) without<br>batteries and<br>other accessories | 272g | Different, the different<br>weight and dimension<br>doesn't affect the safety<br>and effectiveness. | | | 30 | Dimensions<br>(mm.) | 139×68×32mm | 96×160×36mm | 155×83×20.95mm | and effectiveness. | | | 31 | Housing<br>Materials &<br>Construction | Plastic<br>(Injection Molded ABS) | Plastic<br>(Injection Molded ABS) | Polycarbonate and<br>ABS blend;<br>Plexiglass tinted front<br>panel, aluminum ring<br>for structural support | Same with primary<br>predicate device. | | | NMES Waveform | | | | | | | | 1 | Shape | Symmetrical Biphasic | • Symmetrical rectangular<br>Biphasic [TENS and HAN<br>(TENS)]<br>• Symmetrical rectangular<br>Biphasic [NMES] | -- | Similar | | | 2 | Max Output<br>Voltage (V) | 45V @500Ω<br>70V @2kΩ | 45V @500Ω<br>70V @2kΩ | -- | Same | | | | | | | | | | | | ±10% | 70V @10kΩ | 70V @10kΩ<br>(open lead detected above 0.5 [mA]) | | | | | 3 | Max Output Current (mA) ±10% | 90mA @500Ω<br>35mA @2kΩ<br>7mA @10kΩ | 90mA @500Ω<br>35 mA @2kΩ<br>7 mA @10kΩ<br>(open lead detected above 0.5 [mA]) | -- | | | | 4 | Pulse Width | 50-450μs | 50-450μs in 10μs step to 100μs<br>and thereafter 25μs up to 450μs | -- | Same | | | 5 | Frequency (Hz) | 2-100Hz | 2-100Hz in 1Hz steps from 2 to<br>20Hz<br>thereafter in steps of 5Hz up to<br>100Hz | -- | Same | | | 6 | Net Charge (μC/pulse) | 0 μC | 0 μC | -- | Same | | | 7 | Maximum Phase Charge (μC) 500Ω | 40.5μC [90mA for 450μs] | 40.5(μC) [90mA for 450μs] | -- | Same | | | 8 | Average Current(IRMS, 500Ω) | 27mA | Not publicly available | -- | Same | | | 9 | Maximum Average Current Density 500Ω | Electrode pad: 1.42 mA/cm² | 1.42mA /sq cm for electrode of<br>19sq cm | -- | Same | | | 10 | Maximum Average Power Density | Electrode pad: 19 mW/cm² | 19[mW/cm²] @ 500Ω for<br>Electrode of 19sq cm | -- | Same | | | 11 | On Time (sec) | 2-99 secs | 2-99 secs | -- | Same | | | 12 | Off Time (sec) | 2-99 secs | 2-99 secs | -- | Same | | | 13 | Treatment | 1-99 minutes | 2-99 minutes | -- | Similar | | | | Time(min) | | | | | | | | TENS Waveforms | | | | | | | 1 | Shape | Symmetrical Biphasic | Symmetrical<br>rectangular | -- | Same | | | | | | Biphasic | | | | | | | | [TENS and HAN (TENS)] | | | | | 2 | Max Output | 40V @500Ω | 40V @500Ω | | Same | | | | Voltage (V) | 70V @2kΩ | 70V @2kΩ |…