(273 days)
No
The description focuses on electrical stimulation and manual control via a remote, with no mention of AI/ML terms or functionalities like adaptive stimulation based on user feedback or data analysis.
Yes
The device is intended to treat urinary incontinence and promote muscle strengthening for rehabilitation purposes, which aligns with the definition of a therapeutic device.
No
The device is described as providing electrical stimulation and neuromuscular re-education for rehabilitation purposes, specifically to strengthen pelvic floor muscles and treat urinary incontinence. Its function is to induce contractions, not to diagnose a condition.
No
The device description explicitly lists hardware components including a remote control, stimulator pod, and vaginal stimulation probe.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device provides electrical stimulation to the pelvic floor muscles. It is a therapeutic device that directly interacts with the body to induce muscle contractions.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its function is purely based on delivering electrical impulses.
Therefore, the Levina Pelvic Floor Muscle Stimulator falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.
Product codes
KPI
Device Description
Levina Pelvic Floor Muscle Stimulator is a non-implantable, home use device for the treatments of stress, urge, and mixed urine incontinence through the intravaginal probe's electrical stimuli to the muscles of the pelvic floor to induce Kegel-like contractions, which help users to achieve pelvic floor muscle strengthening for maintaining urinary continence in women.
The subject device includes a remote control, a stimulator pod and a vagina stimulation probe. Both the remote control and the stimulator pod are powered by an off-the-shelf 3.7V lithium-ion polymer battery. The remote control has a 1.77" TFT LCD screen and 4 buttons to control the stimulator pod. The stimulator pod has two output channels and will perform electrical stimulation according to the parameter settings sent by the remote control.
The device is supplied with a reusable (single-patient use) vaginal, dual-electrode, stimulation probe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor muscles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home environment
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)
- Biocompatibility testing according to ISO 10993-1:2018 Biological evaluation of medical O devices - Part 1: Evaluation and testing within a risk management process and FDA Guidance "Use of International Standard ISO 10993-1" (2016).
- Electrical Safety testing according to IEC 60601-1: 2020 Medical electrical equipment Basic O safety and essential performance
- Electromagnetic Compatibility testing according to IEC 60601-1-2: 2020 General requirements O for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
- Software Verification and Validation Testing according to FDA's Guidance for the O Content of Premarket Submissions for Software Contained in Medical Devices"
- o Cybersecurity risk management activities according to FDA Guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, issued September 27, 2023
- Performance testing according to IEC 60601-1-11, Medical electrical equipment -- Part 1-11: O General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical systems used in the home healthcare environment
- Performance test according to IEC 60601-2-10, Medical electrical equipment -- Part 2-10: O Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- Electrical performance testing to verify the stimulation parameters O
All pre-determined acceptance criteria were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5320 Nonimplanted electrical continence device.
(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 27, 2025
ZMI Electronics Ltd. Lawrence Liu Section Manager 6F-1, 286-4, Shin Ya Road, Chien Chen District Kaohsiung, 806 TAIWAN
Re: K241862
Trade/Device Name: Levina Pelvic Floor Muscle Stimulator (RS-48) Regulation Number: 21 CFR 876.5320 Regulation Name: Nonimplanted Electrical Continence Device Regulatory Class: II Product Code: KPI Dated: February 25, 2025 Received: February 25, 2025
Dear Lawrence Liu:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
2
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,
Angel A. Soler-garcia -S
for
Jessica K. Nguyen, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology, and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241862
Device Name
Levina Pelvic Floor Muscle Stimulator Model: RS-48
Indications for Use (Describe)
The device is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510 (k) Summary
Submitter Information 1.
| 510 (k) submitter: | ZMI Electronics Ltd. |
|---|---|
| Address: | 6F-1, 286-4, Shin-Ya Road, Kaohsiung, Taiwan 806 |
| Phone: +886-7-8150053 | |
| Fax: +886-7-8150057 | |
| Email: mail@zmi-electronics.com | |
| Applicant Contact Person: | Lawrence Liu |
| Regulatory Affairs Manager | |
| Phone: +886-7-8150053 Ext 351 | |
| Fax: +886-7-8150057 | |
| E-mail: lawrence@zmi-electronics.com | |
| Preparation date: | March 26, 2025 |
2. Device Name
| Trade Name of the Device: | Levina Pelvic Floor Muscle Stimulator Model: RS-48 |
|---|---|
| Common Name: | Nonimplanted electrical continence device |
| Classification Name: | Stimulator, electrical, non-implantable, for incontinence |
| Classification Regulation: | 21 CFR 876.5320 |
| Device Class: | II |
| Panel: | Gastroenterology/Urology |
| Product Code: | KPI |
3. Predicate and Reference Devices
| 510(k)# | Trade Name | |
|---|---|---|
| Predicate | K160773 | Yarlap II |
| Reference | K081480 | Kegel8 |
| Reference | K230983 | Unicare (K-UNICARE-USA) |
The predicate and reference devices have not been subject to a design related recall.
Device Description 4.
Levina Pelvic Floor Muscle Stimulator is a non-implantable, home use device for the treatments of stress, urge, and mixed urine incontinence through the intravaginal probe's electrical stimuli to the muscles of the pelvic floor to induce Kegel-like contractions, which help users to achieve pelvic floor muscle strengthening for maintaining urinary continence in women.
5
The subject device includes a remote control, a stimulator pod and a vagina stimulation probe. Both the remote control and the stimulator pod are powered by an off-the-shelf 3.7V lithium-ion polymer battery. The remote control has a 1.77" TFT LCD screen and 4 buttons to control the stimulator pod. The stimulator pod has two output channels and will perform electrical stimulation according to the parameter settings sent by the remote control.
The device is supplied with a reusable (single-patient use) vaginal, dual-electrode, stimulation probe.
ਹੈ, Indications For Use
The device is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.
Comparison of the Technological Characteristics with Predicate Device 6.
| Technological/ Performance
| Characteristics | Subject Device | Predicate Device | |
|---|---|---|---|
| Trade/Device Name | Levina Pelvic Floor Muscle | ||
| Stimulator | Yarlap II | ||
| 510(k) Number | K241862 | K160773 | |
| Indications for Use | The device is intended to | ||
| provide electrical stimulation | |||
| and | |||
| neuromuscular | |||
| reeducation for the purpose | |||
| of rehabilitation of weak | |||
| pelvic floor muscles for the | |||
| treatment of stress, urge and | |||
| mixed urinary incontinence in | |||
| women | The device is intended to provide | ||
| electrical stimulation and | |||
| neuromuscular re-education for | |||
| the purpose of rehabilitation of | |||
| weak pelvic floor muscles for the | |||
| treatment of stress, urge and | |||
| mixed urinary incontinence in | |||
| women | |||
| Environments of Use | Home environment | Home environment | |
| Target Population | women with incontinence or | ||
| weak pelvic floor muscles | women with incontinence or weak | ||
| pelvic floor muscles | |||
| Prescription or Over-the-Counter | |||
| (OTC) | Prescription Use & OTC | Prescription Use & OTC | |
| Electrode Types | Incontinence probe | Incontinence probe | |
| Waveform | Biphasic, Symmetrical | Biphasic, Symmetrical | |
| Shape | Rectangular | Rectangular | |
| Maximum | |||
| Output | |||
| Voltage | |||
| (volts) | @500Ω | 40 | 40 |
| @2kΩ | 50 | 50 | |
| @10kΩ | 50 | 95 | |
| Maximum | |||
| Output | |||
| Current (mA) | @500Ω | 80 | 80 |
| @2kΩ | 25 | 50 | |
| @10kΩ | 5 | 19 | |
| Pulse Width (usec) | 200~300 | 200~250 | |
| Frequency (Hz) | 12~50 | 2~100 |
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K241862 Page 3 of 4
| For multiphasic waveforms only: | Symmetrical phases | Yes | Yes |
|---|---|---|---|
| Phase Duration (µsec) | 20-150 | 100~125 | |
| Maximum Phase Charge (@500Ω) (µC) | 12 | 10 | |
| Electrode Area | 6cm² | 6.4cm² | |
| Maximum (peak) Current Density (mA/cm²) | 13.33 | 12.5 | |
| Maximum Current Density (@500Ω) (mA/cm²) rms | 1.63 | 1.98 | |
| Maximum Average Current (average absolute value), (mA) | 1.2 | 2 | |
| Maximum Average Power Density (@500Ω) (mW/cm2) | 8 | 12.5 |
As evidenced by the above table, both the subject and the predicate devices have the same intended use, but the subject and predicate devices have different technological characteristics. The reference devices were used to support the stimulation parameters of the subject device. Additionally, performance testing was conducted on the subject device to evaluate its safety and effectiveness. Overall, it was established that the differences in technological characteristics between the subject and the predicate does not raise different questions of safety or effectiveness.
7. Non-Clinical Testing
Below is a list of the tests that were performed and successfully completed for the subject device per the specified guidance and standards:
- Biocompatibility testing according to ISO 10993-1:2018 Biological evaluation of medical O devices - Part 1: Evaluation and testing within a risk management process and FDA Guidance "Use of International Standard ISO 10993-1" (2016).
- Electrical Safety testing according to IEC 60601-1: 2020 Medical electrical equipment Basic O safety and essential performance
- Electromagnetic Compatibility testing according to IEC 60601-1-2: 2020 General requirements O for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
- Software Verification and Validation Testing according to FDA's Guidance for the O Content of Premarket Submissions for Software Contained in Medical Devices"
- o Cybersecurity risk management activities according to FDA Guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, issued September 27, 2023
- Performance testing according to IEC 60601-1-11, Medical electrical equipment -- Part 1-11: O General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical systems used in the home healthcare environment
- Performance test according to IEC 60601-2-10, Medical electrical equipment -- Part 2-10: O Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
7
- Electrical performance testing to verify the stimulation parameters O
All pre-determined acceptance criteria were met.
8. Conclusions
Based on the information presented in this submission, it can be concluded that the subject device is substantially equivalent to the predicate.