← Product Code [KPI](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPI) · K251026 # Regenesis EMS Chair (K251026) _Trinity Medical Solutions · KPI · Aug 29, 2025 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPI/K251026 ## Device Facts - **Applicant:** Trinity Medical Solutions - **Product Code:** [KPI](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPI.md) - **Decision Date:** Aug 29, 2025 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.5320 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for Use The ReGenesis EMS Chair is intended to provide non-invasive electromagnetic stimulation to a weak pelvic floor muscle for the purpose of rehabilitation. The procedure is intended to strengthen the pelvic floor muscle and restore the neuromuscular control for the treatment of urinary incontinence in both male and female patients. ## Device Story ReGenesis EMS Chair is a non-invasive electromagnetic muscle stimulation device; used in hospitals/clinics by trained professionals. Device consists of a chair containing an electromagnetic coil and a wired touch-screen control panel. Clinician selects therapy parameters; device generates magnetic fields to stimulate pelvic floor muscles; intended to strengthen muscles and restore neuromuscular control. Output is electromagnetic stimulation; helps treat urinary incontinence. Device includes internal power supply and cooling system. ## Clinical Evidence Bench testing only. Testing included electrical safety (IEC 60601-1:2020), electromagnetic compatibility (IEC 60601-1-2:2020), and nerve/muscle stimulator safety (IEC 60601-2-10:2016). Performance bench data included service life verification and stimulation coil surface temperature rise testing. All acceptance criteria were met. ## Technological Characteristics Electromagnetic muscle stimulator; magnetic field strength 2T±20%; pulse width 310μs (±20μs); pulse repetition rate 1-50 Hz; rectangular biphasic pulse shape. Powered by AC 110-120V. Features touch screen interface, internal cooling system, and magnetic coil applicator. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-10 standards. ## Regulatory 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). ## Predicate Devices - HPM-6000UF ([K181497](/device/K181497.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION August 29, 2025 Trinity Medical Solutions % Jamie Owsiany Official Correspondent Hoy and Associates Regulatory Consulting 1830 Bonnie Way Sacramento, California 95825 Re: K251026 Trade/Device Name: Regenesis EMS Chair Regulation Number: 21 CFR 876.5320 Regulation Name: Nonimplanted Electrical Continence Device Regulatory Class: Class II Product Code: KPI Dated: July 31, 2025 Received: August 1, 2025 Dear Jamie Owsiany: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K251026 - Jamie Owsiany Page 2 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 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 QS 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 (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 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 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 Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. {2} K251026 - Jamie Owsiany Page 3 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, Jessica K. Nguyen -S Jessica Nguyen 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} FORM FDA 3881 (6/20) Page 1 of 1 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) K251026 | | | Device Name ReGenesis EMS Chair | | | Indications for Use (Describe) The ReGenesis EMS Chair is intended to provide non-invasive electromagnetic stimulation to a weak pelvic floor muscle for the purpose of rehabilitation. The procedure is intended to strengthen the pelvic floor muscle and restore the neuromuscular control for the treatment of urinary incontinence in both male and female patients. | | | 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." | | {4} K251026 Page 1 of 3 # 510 (k) Summary ## 1. Submitter Information 510 (k) submitter: Trinity Medical Solutions Address: 105 Citation Court Homewood, AL 35209 Applicant Contact Person: Mr. Mark Rohrer Phone: 205-356-1172 Email: Mrohrer0603@gmail.com Correspondent Contact: Mrs. Jamie Carlton Phone: 706-399-1304 Email: jamieowsiany@hoyregulatory.com Preparation date: August 29, 2025 ## 2. Device Name Trade Name of the Device: ReGenesis EMS Chair 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 Device | 510(k) Number | Trade Name of the Device | | --- | --- | | Predicate: K181497 | HPM-6000UF | The predicate device was never subjected to a design related recall. ## 4. Device Description The ReGenesis Chair is an electromagnetic muscle stimulation device. It is intended to provide non-invasive electromagnetic stimulation to a weak pelvic floor muscle for the purpose of rehabilitation. The procedure is intended to strengthen the pelvic floor muscle and restore the neuromuscular control for the treatment of urinary incontinence in both adult male and female patients. This is intended to be operated by trained professionals only. {5} K251026 Page 2 of 3 The ReGenesis EMS Chair consists of the main unit (the chair) and a wired, color, touch screen, control Panel. The device consists of a control unit that internally houses a power supply, cooling system, user interface, and control system. The electromagnetic coil is contained in the chair applicator, which is fashioned as a seat for the patient. The subject device uses electromagnetic fields to stimulate the muscles of the pelvic floor. # 5. Indications For Use The ReGenesis EMS Chair is intended to provide non-invasive electromagnetic stimulation to a weak pelvic floor muscle for the purpose of rehabilitation. The procedure is intended to strengthen the pelvic floor muscle and restore the neuromuscular control for the treatment of urinary incontinence in both male and female patients. # 6. Comparison of the Technological Characteristics with Predicate Device | Device & Predicate Device(s): | K251026 (Subject) | K181497 (Predicate) | | --- | --- | --- | | Device Name | ReGenesis EMS Chair | BTL HPM-6000U | | Indication for use | The ReGenesis EMS Chair is intended to provide non-invasive electromagnetic stimulation to a weak pelvic floor muscle for the purpose of rehabilitation. The procedure is intended to strengthen the pelvic floor muscle and restore the neuromuscular control for the treatment of urinary incontinence in both male and female patients. | HPM-6000UF is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female urinary incontinence. | | Function | Pelvic floor muscle stimulation | Pelvic floor muscle stimulation | | Type of energy | Magnetic field | Magnetic field | | Power source | AC110 - 120V, 50/60Hz, 12A | 100-240 V AC, 50-60 Hz, max 14 A | | Therapy Process | Specific therapy parameters are selected by the clinician based on the patient's symptoms. | Specific therapy mode is selected by the clinician based on the patient's symptoms. | | Pulse shape | Rectangular biphasic | Sine, biphasic | | Therapy modes | Single continuous manual mode | Single continuous manual mode | | Applicator | Chair | Chair | | Stimulation source | Magnetic coil | Magnetic coil | | Magnetic field strength | 2T±20% | 0.7-2.5 T | | Pulse width | 310μs (±20μs) | 280 μs (±20%) | | Pulse repetition rate | 1-50 Hz | 1-150 Hz | | Applicator dimensions (WxHxD) | 27x24x27 in. | 29x29x29 in. | | Variation of Pulse intensity (dB/dt) | Up to 24 mT/ μs±20% | Up to 28 mT/ μs±20% | {6} K251026 Page 3 of 3 | Pulse amplitude adjustment | 0-100% | 0-100% | | --- | --- | --- | | Therapy time / regimen | 0-30 mins; separated by at least 2 days | 0-60 min session (recommend 30 min); separated by at least 2 days | | Interface | Touch screen | Touch screen | | Firmware controlled | Yes | Yes | | Treatment Environment | Hospital/Clinics only | Hospital/Clinics only | As evidenced by the above table, both the subject and the predicate devices have similar intended use, but the subject and predicate devices have different technological characteristics. However, the differences in technological characteristics between the subject and the predicate do not raise different questions of safety or effectiveness. Performance testing was conducted on the subject device to demonstrate substantial equivalence to the predicate device. ## 7. Non-Clinical Testing Below is a list of the tests that were performed and successfully completed for the subject device per the below guidance and standards: - Electrical Safety testing according to IEC 60601-1: 2020 - Medical electrical equipment – Basic safety and essential performance - 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 - IEC 60601-2-10:2016 – Particular requirements for the basic safety and essential performance of nerve and muscle stimulators - Software Verification and Validation Testing according to FDA’s Guidance “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” Additionally, performance bench data was submitted for device performance and durability of the subject device. This data included: - Service life verification test - Stimulation Coil Surface Temperature Rise Test 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. --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPI/K251026](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPI/K251026) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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