(156 days)
Not Found
No
The document describes standard electrical stimulation and biofeedback techniques. While it mentions a microprocessor and an "automated regime" for the ETS threshold, there is no indication of learning, adaptation, or complex pattern recognition characteristic of AI/ML. The "automated regime" likely refers to a pre-programmed algorithm rather than a learning system.
Yes
The device is described as a "multi-patient device intended to be used by adult patients under the supervision of a trained clinical healthcare provider" and its intended uses include a variety of therapeutic applications such as pain relief, prevention of disuse atrophy, muscle re-education, and treatment of urinary incontinence.
No
The device is primarily a therapeutic device (NMES, TENS, ETS) with a biofeedback function (EMG Biofeedback) that displays muscle strength, which is used for training and re-education, not for diagnosing a medical condition. While it assesses EMG activity, this is for guiding treatment or training, not for providing a medical diagnosis.
No
The device description explicitly lists hardware components such as the "Main device", "Pedestal", "Lead wire", "Electrode pad", "Vaginal probe", and "Rectal probe". While it includes optional PC software, the core functionality and delivery of therapy rely on physical hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Levator Elite (Model LE9011) is an electrical stimulation and biofeedback device. It works by applying electrical currents to the body or detecting electrical signals from muscles. It does not analyze specimens taken from the body.
- Intended Use: The intended uses listed (muscle relaxation, atrophy prevention, circulation increase, muscle re-education, pain relief, incontinence treatment) are all related to physical therapy, pain management, and muscle function, not the analysis of biological samples.
- Device Description: The description details the electrical stimulation and biofeedback functions, the components (electrodes, probes), and how it interacts with the body externally or internally via probes, not through the analysis of collected specimens.
Therefore, the Levator Elite (Model LE9011) falls under the category of a therapeutic or rehabilitative medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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) (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
Product codes (comma separated list FDA assigned to the subject device)
IPF, KPI, HCC, GZJ
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 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)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor, calf muscles, pelvic floor and accessory muscles (abdominal or gluteal)
Indicated Patient Age Range
Adult
Intended User / Care Setting
under the supervision of a trained clinical healthcare provider.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data are provided in support of the substantial equivalence determination:
6.1 Biocompatibility testing
The Levator Elite (Model LE9011) itself has no direct contact with the patient. The accessories (Electrode pad, Vaginal probe and Rectal probe) would be the primary patient-contacting components, as they have direct contact with the patient at the treatment site. The biocompatibility evaluation for the accessories (Electrode pad, Vaginal probe and Rectal probe) was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process". The testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
6.2 Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the subject device. The system complies with the IEC 60601-1, IEC60601-1-11 and IEC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC.
6.3 Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern.
6.4 Output waveform Testing
For each program, oscilloscope tracing diagrams describing the electrical output waveform was provided to verify the output specifications of the device according to IEC 60601-2-10.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.5850 Powered muscle stimulator.
(a)
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.(b)
Classification. Class II (performance standards).
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 (