Who is the manufacturer of Levator Elite (Model LE9011)?

Shenzhen Dongdixin Technology Co., Ltd. filed the 510(k) submission for Levator Elite (Model LE9011) (K213043).

What is the FDA product code for Levator Elite (Model LE9011)?

IPF. It is classified under 21 CFR 890.5850 as a Class 2 device in the Physical Medicine panel.

What is the regulatory pathway for Levator Elite (Model LE9011)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Levator Elite (Model LE9011)?

Medline DeNovo 4Pro Electrical Stimulation Device (K201290); MyOnyx System (K201014).

Who can help prepare an FDA 510(k) submission like Levator Elite (Model LE9011)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Levator Elite (Model LE9011)

K213043 · Shenzhen Dongdixin Technology Co., Ltd. · IPF · Feb 25, 2022 · Physical Medicine

Device Facts

Record ID	K213043
Device Name	Levator Elite (Model LE9011)
Applicant	Shenzhen Dongdixin Technology Co., Ltd.
Product Code	IPF · Physical Medicine
Decision Date	Feb 25, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 890.5850
Device Class	Class 2
Attributes	Therapeutic

Intended 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) (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

Device Story

Levator Elite (LE9011) is a single-channel, battery-powered, hand-held device for adult patients under clinical supervision. It delivers electrical stimulation via surface electrodes, vaginal probes, or rectal probes. Inputs include EMG signals from muscles; device processes these via microprocessor to provide biofeedback (bar graph/waveform) or trigger electrical stimulation (ETS). Modes include NMES (muscle contraction), TENS (pain relief), ETS (incontinence treatment), and EMG (biofeedback). Device can operate standalone or link to PC via USB for data transmission. Healthcare providers use output to monitor muscle activity, manage pain, or guide pelvic floor/muscle rehabilitation. Benefits include improved urinary control, pain management, and muscle function recovery.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility testing (cytotoxicity, sensitization, irritation per ISO 10993-1), electrical safety and EMC testing (IEC 60601-1, 60601-1-11, 60601-2-10, 60601-1-2), software verification and validation, and output waveform verification via oscilloscope tracing.

Technological Characteristics

Hand-held, battery-powered (4xAA) stimulator. Materials: ABS plastic housing. Sensing: Bipolar EMG detection (20-500 Hz). Output: Symmetrical biphasic waveforms; constant current regulation. Connectivity: USB for PC data transmission. Safety: Type BF applied part, automatic overload/no-load/shut-off features. Standards: IEC 60601-1, 60601-1-2, 60601-1-6, 60601-2-10.

Indications for Use

Indicated for adult patients requiring NMES for muscle spasm relaxation, disuse atrophy prevention, blood circulation, muscle re-education, post-surgical calf stimulation, or range of motion maintenance; ETS for stress, urge, or mixed urinary incontinence and pelvic floor EMG assessment; TENS for chronic intractable pain or post-surgical/traumatic acute pain; and EMG for biofeedback and muscle training.

Regulatory Classification

Identification

A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

Predicate Devices

Medline DeNovo 4Pro Electrical Stimulation Device (K201290)
MyOnyx System (K201014)

Related Devices

K202648 — Biofeedback Nerve and Muscle Stimulator · Shenzhen Konmed Technology Co., Ltd. · Dec 8, 2020
K210002 — STELLA BIO · Egzotech Sp. Z O. O. · Oct 1, 2021
K201290 — Medline DeNovo 4Pro Electrical Stimulation Device · Medline Industries, Inc. · Sep 21, 2020
K243079 — NeuroTrac® MyoPlus Pro (MYO120U) · Verity Medical , Ltd. · Jun 26, 2025
K050483 — EVADRI BLADDER CONTROL SYSTEMS · Hollister, Inc. · Apr 12, 2005

Submission Summary (Full Text)

{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. Existing major regulations affecting your device can be found in the Code of {1}------------------------------------------------ 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 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 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. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue, except for the X in DONGDIXIN, which is in yellow. 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 Estate Xilixiaobaimang 518108 Nanshan District, 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 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 device | S.E. Discussion | |-----|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------| | 1 | 510K# | K213043 | K201290 | K201014 | N/A | | 2 | Device Name and Model | Levator Elite(Model LE9011) | Medline DeNovo 4Pro Electrical Stimulation Device | MyOnyx System | N/A | | 3 | Manufacturer | Shenzhen Dongdixin Technology Co., Ltd. | Medline (Sponsor) Verity (Manufacturer) | Thought Technology Ltd. | N/A | | 4 | Product Code | IPF KPI HCC GZJ | IPF KPI HCC GZJ GZI | KPI HCC | Similar, the proposed device does not have FES function. | | 5 | Classification Code | Class II | Class II | Class II | Same | | 6 | Regulation Number | 21 CFR 890.5850 21 CFR 876.5320 21 CFR 882.5050 21 CFR 882.5890 | 21 CFR 890.5850 21 CFR 876.5320 21 CFR 882.5050 21 CFR 882.5890 21 CFR 882.5810 | 21 CFR 876.5320 21 CFR 882.5050 | Similar, the proposed device does not have FES function. | | 7 | 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 | For EMG mode: - Relaxation muscle training and muscle re-education For NMES (also known as STIM) mode: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood | The MyOnyx System is indicated for acute and ongoing treatment of stress, urge, or mixed urinary incontinence, where urinary control may be improved through electrical stimulation that strengthens the | Similar, the proposed device does not have FES 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 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 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) 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 | circulation - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion - Muscle Re-Education For TENS mode: - Symptomatic relief and management of chronic (long-term), intractable pain - Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain For 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 muscles or inhibits the detrusor muscle through reflexive mechanisms. The system also uses EMG-based or pressure-based biofeedback to help control and strengthen the pelvic floor muscles in the treatment of urinary incontinence. | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| {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 muscles (abdominal or gluteal) | | | | |-----------------------------------------------|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | | | | For FES - Helps to relearn voluntary motor functions of the extremities | | | | | 8 | Prescription vs. OTC | Prescription Use | Prescription Use | Prescription Use | Same | | | 9 | Sterile vs. Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Same | | | 10 | Waveforms | Symmetrical Biphasic | ● Symmetrical Biphasic DC zero[TENS and HAN (TENS)] ● Symmetrical Biphasic [NMES] | Symmetrical, rectangular, bipolar, biphasic | Same | | | 11 | Target Population | Adult | Adult | Adult | Same | | | 12 | Power Source | DC 6V, 4*AA batteries | 4x AA NiMh 4.8V Rechargeable Battery pack | Internal Battery (not user replaceable): Rechargeable (3200mAh) Li-ion Polymer battery certified to IEC 62133 - up to 8 hours of autonomous device operation; External 15W, 5V Medical Grade (Class II Double Insulated) Power Supply /Battery Charger | Different, but the proposed device has passed the testing according to the requirement of IEC60601-1. The difference does not raise any safety issue. | | | 13 | Electrical Type | Type BF | Type BF | Type BF | Same | | | 14 | Patient Leakage Current (μΑ) -Normal condition | 1uA | N/A Battery Operated Device (<100 µA patient leakage) | / | Different, but the proposed device has passed the testing according to the requirement of IEC60601-1. The difference does not raise any safety issue. | | | 15 | Patient Leakage Current (μΑ) -Single fault condition | N/A | N/A Battery Operated Device (<100 µA patient leakage) | / | Same | | | 16 | Number of Output Modes | Two ● Muscle stimulator: Electrodes ● TENS (Transcutaneous electrical nerve stimulator): Electrodes | Two ● Muscle stimulator: Electrodes ● TENS (Transcutaneous electrical nerve stimulator): Electrodes | One ● Muscle stimulator: Electrodes | Same with primary predicate device. | | | 17 | Number of Output Channels | 1 | 4 | 4 | Different, the number of output channels is the feature of device, doesn't affect the safety and effectiveness. | | | 18 | Synchronous or Alternating? | N/A, one channel | Synchronous and Alternating | / | Different, the proposed device has one channel. | | | 19 | Method of Channel Isolation | N/A, one channel | Each channel is the middle of an H bridge. Each channel is in a high impedance state except when it is activated for a specific output pulse | / | | | | 20 | Regulated | Constant current | Constant current on all four | Constant current | Same | | | | Current or Regulated Voltage? | | channels | | | | | 21 | Software/Firmw are/ Micro processor Control? | Yes | Yes | Yes | Same | | | 22 | Automatic 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 Load contact Trip | Yes | Yes | Yes | Same | | | 24 | Automatic Shut off | Yes | Yes | Yes | Same | | | 25 | User Override Control? | Yes | Yes | Yes | Same | | | 26 | Indicator Display: - On/Off - Low Battery? - Voltage/ Current Level? | Yes | Yes | Yes | Same | | | 27 | Compliance with Voluntary Standards? | Yes IEC 60601-1:2005+A1:2012 IEC60601-1-2 IEC 60601-1-6 IEC 60601-2-10 | Yes IEC 60601-1:2005+A1:2012 IEC60601-1-2 IEC 60601-1-6 IEC 60601-2-10 | Yes IEC/ES 60601-1 (Ed. 3.1) IEC 60601-1-6 IEC 60601-2-10 | Similar | | | | | | FCC PART 15 Subpart B:2008 Class B FCC CFR Title 47 Part 15 Subpart C | IEC 60601-2-40 IEC 60601-1-2 (4th Ed.) | | | | 28 | Compliance with 21 CFR 898? | Yes. leads with conductive connection to a patient are constructed such that no conductive connection remote from the patient can contact earth or hazardous voltages | Yes. leads with conductive connection to a patient are constructed such that no conductive connection remote from the patient can contact earth or hazardous voltages | Yes. | Same | | | 29 | Weight (grams.) | 158g without batteries | 160 grams (0.35 lbs) without batteries and other accessories | 272g | Different, the different weight and dimension doesn't affect the safety and effectiveness. | | | 30 | Dimensions (mm.) | 139×68×32mm | 96×160×36mm | 155×83×20.95mm | and effectiveness. | | | 31 | Housing Materials & Construction | Plastic (Injection Molded ABS) | Plastic (Injection Molded ABS) | Polycarbonate and ABS blend; Plexiglass tinted front panel, aluminum ring for structural support | Same with primary predicate device. | | | NMES Waveform | | | | | | | | 1 | Shape | Symmetrical Biphasic | • Symmetrical rectangular Biphasic [TENS and HAN (TENS)] • Symmetrical rectangular Biphasic [NMES] | -- | Similar | | | 2 | Max Output Voltage (V) | 45V @500Ω 70V @2kΩ | 45V @500Ω 70V @2kΩ | -- | Same | | | | | | | | | | | | ±10% | 70V @10kΩ | 70V @10kΩ (open lead detected above 0.5 [mA]) | | | | | 3 | Max Output Current (mA) ±10% | 90mA @500Ω 35mA @2kΩ 7mA @10kΩ | 90mA @500Ω 35 mA @2kΩ 7 mA @10kΩ (open lead detected above 0.5 [mA]) | -- | | | | 4 | Pulse Width | 50-450μs | 50-450μs in 10μs step to 100μs and thereafter 25μs up to 450μs | -- | Same | | | 5 | Frequency (Hz) | 2-100Hz | 2-100Hz in 1Hz steps from 2 to 20Hz thereafter in steps of 5Hz up to 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 19sq cm | -- | Same | | | 10 | Maximum Average Power Density | Electrode pad: 19 mW/cm² | 19[mW/cm²] @ 500Ω for 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 rectangular | -- | Same | | | | | | Biphasic | | | | | | | | [TENS and HAN (TENS)] | | | | | 2 | Max Output | 40V @500Ω | 40V @500Ω | | Same | | | | Voltage (V) | 70V @2kΩ | 70V @2kΩ |…