Pelvic Floor Exerciser (PF01)
Device Facts
| Record ID | K252748 |
|---|---|
| Device Name | Pelvic Floor Exerciser (PF01) |
| Applicant | Hunan Accurate Bio-Medical Technology Co., Ltd. |
| Product Code | HIR · Obstetrics/Gynecology |
| Decision Date | Apr 27, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.1425 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Pelvic Floor Exerciser is a perineometer designed to treat stress, mild-moderate urge and mixed urinary incontinence in women, by strengthening of the pelvic floor muscles through exercise. This device provides biofeedback via smart phone technology. Pelvic Floor Exerciser is indicated for an adult female.
Device Story
Device is a perineometer for pelvic floor muscle strengthening; consists of a vaginal probe with force-sensing resistors covered by a medical-grade silicone sheath. User inserts probe into vagina; sensors measure contraction strength of pubococcygeus and puborectalis muscles. Data transmitted wirelessly to a smartphone application; app provides real-time visual biofeedback via games based on Kegel exercise principles. Intended for over-the-counter, single-patient, reusable use. Healthcare providers use the output to monitor patient progress in muscle strengthening; patients use the visual feedback to guide and improve the efficacy of voluntary Kegel exercises, potentially reducing symptoms of urinary incontinence.
Clinical Evidence
No clinical data. Evidence consists of bench testing, including biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1, IEC 60601-1-11), EMC (IEC 60601-1-2, IEC 60601-4-2), software/cybersecurity validation, and performance bench data (tensile strength, bending, cleaning validation, sensor accuracy, Bluetooth stability, and service life).
Technological Characteristics
Materials: PC/ABS rigid structure with medical-grade silicone outer layer. Sensing: Force sensing resistors. Energy: 3.0VDC non-rechargeable batteries. Connectivity: Wireless Bluetooth to smartphone. Form factor: Two egg-shaped sensing areas, 88.5mm shaft length. Sterilization: Not specified (reusable). Software: Smartphone GUI for biofeedback.
Indications for Use
Indicated for adult females with stress, mild-moderate urge, or mixed urinary incontinence to strengthen pelvic floor muscles via exercise.
Regulatory Classification
Identification
A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.
Predicate Devices
- Perifit Care+ (K231780)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
April 27, 2026
Hunan Accurate Bio-Medical Technology Co., Ltd.
Yanhong Mo
Regulatory Engineer
Accurate Industrial Park, No.108, Zhixian Rd.
Xuelian Community, Xueshi Street of Yuelu District
Changsha, Hunan 410208
CHINA
Re: K252748
Trade/Device Name: Pelvic Floor Exerciser (PF01)
Regulation Number: 21 CFR 884.1425
Regulation Name: Perineometer
Regulatory Class: II
Product Code: HIR
Dated: August 29, 2025
Received: March 30, 2026
Dear Yanhong Mo:
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: The Center for Devices and Radiological Health (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, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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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" (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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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 Rule"). 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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
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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-devices/device-advice-comprehensive-regulatory-assistance/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,
# Negeen Haghighi -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
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FORM FDA 3881 (6/20)
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PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K252748 | |
| Device Name Pelvic Floor Exerciser (PF01) | |
| Indications for Use (Describe) | |
| The Pelvic Floor Exerciser is a perineometer designed to treat stress, mild-moderate urge and mixed urinary incontinence in women, by strengthening of the pelvic floor muscles through exercise. This device provides biofeedback via smart phone technology. Pelvic Floor Exerciser is indicated for an adult female. | |
| 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." | |
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K252748
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# K252748
510(K) SUMMARY
## 1. SUBMITTER INFORMATION
510(k) Submitter: Hunan Accurate Bio-Medical Technology Co., Ltd.
Address: Accurate Industrial Park, No. 108, Zhixian Road, Xuelian Community, Xueshi Street of Yuelu District, Changsha, Hunan 410208, China
Applicant Contact Person: Mr. Li Zhang, General Manager
Phone: +86 731-8559853
E-Mail: regulation@accbiomed.com
Correspondent Contact: Mrs. Yanhong Mo, Regulatory Engineer
Hunan Accurate Bio-Medical Technology Co., Ltd.
Accurate Industrial Park, No. 108, Zhixian Road, Xuelian Community, Xueshi Street of Yuelu District, Changsha, Hunan 410208, China
Phone: +86 18682041674
E-Mail: regulation@accbiomed.com.
Date Summary Prepared: April 22, 2026
## 2. DEVICE NAME
Trade Name of the Device: Pelvic Floor Exerciser (PF01)
Common Name: Perineometer
Classification Name: Perineometer
Classification Regulation: 21 CFR 884.1425
Device Class: Class II
Panel: Gastroenterology/Urology
Product Code: HIR
## 3. PREDICATE DEVICE
Predicate Devices: Perifit Care+510(k) number
Company Name: X6 Innovations
The predicate device has not been subject to a design related recall.
## 4. DEVICE DESCRIPTION
The Pelvic Floor Exerciser (PF01) device consists of a vaginal probe covered in a silicone sheath that is temporarily inserted into the vagina. Sensors located under the silicone sheath measure the strength of contraction of the user's pelvic floor muscles. This information is then transmitted wirelessly to a smartphone application in order to provide real-time visual feedback to the user regarding muscle contraction strength during pelvic floor muscle exercise. The smartphone application includes special games that are based on Kegel exercise principles. It is a single-patient, reusable device supplied over the counter.
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# 5. INDICATION FOR USE
The Pelvic Floor Exerciser is a perineometer designed to treat stress, mild-moderate urge and mixed urinary incontinence in women, by strengthening of the pelvic floor muscles through exercise. This device provides biofeedback via smart phone technology.
Pelvic Floor Exerciser is indicated for an adult female.
# 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE
| Technical Characteristics | Subject Device: Pelvic Floor Exerciser (PF01) (K252748) | Predicate Device: Perifit care + (K231780) |
| --- | --- | --- |
| Indication For Use | The Pelvic Floor Exerciser is a perineometer designed to treat stress, mild-moderate urge and mixed urinary incontinence in women, by strengthening of the pelvic floor muscles through exercise. This device provides biofeedback via smart phone technology.
Pelvic Floor Exerciser is indicated for an adult female. | Perifit Care+ is a perineometer designed to treat stress, mild-moderate urge and mixed urinary incontinence in women, by strengthening of the pelvic floor muscles through exercise. This device provides biofeedback via smart phone technology.
Perifit Care+ is indicated for an adult female. |
| Mode of Use | Reusable for single patient | Reusable for single patient |
| Principle of Operation | A probe inserted into the vagina to determine the strength of the pelvic floor muscles. Probe sends signals to external device to indicate muscle contraction strength to encourage and assist user with voluntary Kegel exercises. | A probe inserted into the vagina to determine the strength of the pelvic floor muscles. Probe sends signals to external device to indicate muscle contraction strength to encourage and assist user with voluntary Kegel exercises. |
| Sensing method | Output from force sensing resistors (wireless). | Output from force sensing resistors (wireless). |
| Sensor's placement | Inside the rigid plastic enclosure | Inside the rigid plastic enclosure |
| Materials | Rigid plastic (PC/ABS) structure enclosed within a medical grade silicone outer layer | Rigid plastic (PC/ABS) structure enclosed within a medical grade silicone outer layer |
| Parameter monitored | Analogue to digital output of uncalibrated force exerted against external walls of device by pubococcygeus and puborectalis muscles. | Analogue to digital output of uncalibrated force exerted against external walls of device by pubococcygeus and puborectalis muscles. |
| Motion Sensor | Present | Present |
| User Interface | Smartphone GUI | Smartphone GUI |
| Anatomical Sites | Female Pubococcygeus muscle area | Female Pubococcygeus muscle area |
| External shape | Two egg shaped sensing areas | Two egg shaped sensing areas |
| Shaft length | 88.5 mm | 87.5 mm |
| Weight | 42g | 40g |
| Power Source | Non-rechargeable batteries Voltage 3.0VDC | Non-rechargeable batteries Voltage 3.0VDC |
As shown in the table above, the subject and predicate devices have similar intended use and technological characteristics. Performance testing was conducted on the subject device to establish its safety and effectiveness.
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# 7. NON-CLINICAL TESTING
Below is a list of the tests that were performed and successfully completed for the subject device per the following guidance and standards.
- Biocompatibility Testing in accordance with FDA Guidance: Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process"
- Electrical Safety testing according to IEC 60601-1: 2020 - Medical electrical equipment – Basic safety and essential performance and IEC 60601-1-11:2020 -Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- Electromagnetic Compatibility testing according to IEC 60601-1-2: 2020 - General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances --Requirements and tests and IEC 60601-4-2:2024-Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic compatibility - Test plan and test report
- Software Verification and Validation Testing according to FDA’s Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- Cybersecurity Verification and Validation Testing according to FDA’s Guidance: Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions
Additionally, performance bench data was submitted to support device performance and durability of the subject device. This data included:
- Probe Tail Tensile Strength Testing
- Probe Tail Excessive Bending Testing
- Cleaning Validation Testing
- Sensor Accuracy and Range Testing
- Bluetooth Signal Strength And Connection Stability Testing
- Dimensional Verification Testing
- Vibration and Drop Testing
- Service Life Verification Testing Including Battery Consumption Test
All pre-determined acceptance criteria were met.
# 8. CONCLUSION
Based on the information presented in this submission, it can be concluded that the subject device is substantially equivalent to the predicate.
