← Product Code [QRC](/productcode/QRC) · K252809 # in2 Smart (in2S) (K252809) _Virility Medical , Ltd. · QRC · Apr 6, 2026 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K252809 ## Device Facts - **Applicant:** Virility Medical , Ltd. - **Product Code:** [QRC](/productcode/QRC.md) - **Decision Date:** Apr 6, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.5026 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for Use The in2 Smart is indicated for management of premature ejaculation in males who ejaculate after intromission. It is designed to increase the time between arousal and ejaculation by delivery of short duration, low-intensity electrical stimulation to the perineal muscles and nerves during intercourse. ## Device Story Wearable hybrid device for premature ejaculation management; consists of reusable electrical stimulation control unit (Smart Pod) and disposable hydrogel contact pads. Applied to perineum prior to intercourse; delivers low-intensity electrical muscle stimulation (EMS) to perineal muscles/nerves. Contraction of pelvic floor muscles delays rhythmic contractions associated with ejaculation. User-adjustable intensity (Low: 9.9mA; High: 14.3mA); max duration 30 minutes. Operated by patient (OTC). Benefits include increased time between arousal and ejaculation. Reusable components include Smart Pod and Case; disposable components are Contact Pads. ## Clinical Evidence Bench testing only. Includes electrical safety, EMC testing, and software verification/validation per IEC 62304. Biocompatibility testing performed per ISO 10993-1:2018 (cytotoxicity, sensitization, irritation). Usability testing confirmed device safety and effectiveness for intended users. ## Technological Characteristics Hybrid wearable; reusable control pod and disposable hydrogel/electrode contact pads. Energy source: electrical stimulation (9.9mA or 14.3mA). Biocompatibility: ISO 10993-1. Software: IEC 62304 compliant. Non-sterile. Dimensions/form factor: perineal patch. ## Regulatory Identification A non-implanted electrical stimulation device for management of premature ejaculation is intended to be used in patients with premature ejaculation by delivery of electrical stimulation to the perineal muscles and nerves. ## Special Controls In combination with general controls of the Food Drug & Cosmetic Act, the non-implanted electrical stimulation device for management of premature ejaculation is subject to the following special controls: *Classification.* Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible. (2) Performance testing must demonstrate the electromagnetic compatibility, electrical safety, and thermal safety of the device. (3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Mechanical performance; (ii) Electrical stimulation parameters; and (iii) Battery performance. (4) Performance testing must support shelf life by demonstrating continued device functionality over the identified shelf life. (5) Software verification, validation, and hazard analysis must be performed. (6) Labeling must include: (i) Specific instructions regarding safe placement and correct use of the device; (ii) Warning(s) against use by patients with active implanted medical devices; and (iii) A shelf life. ## Predicate Devices - vPATCH ([K223595](/device/K223595.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 April 6, 2026 Virility Medical Ltd. Natalie Shukrun Director of QA & RA 24 Ha-Nagar St Hod HaSharon, Central 4527713 ISRAEL Re: K252809 Trade/Device Name: in2 Smart (in2S) Regulation Number: 21 CFR 876.5026 Regulation Name: Non-Implanted Electrical Stimulation Device For Management of Premature Ejaculation Regulatory Class: II Product Code: QRC Dated: March 9, 2026 Received: March 9, 2026 Dear Natalie Shukrun: 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, 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 {1} K252809 - Natalie Shukrun 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 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 {2} K252809 - Natalie Shukrun Page 3 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, Mark R. Kreitz -S for Mark J. Antonino, M.S. 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 (8/23) 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: 07/31/2026 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K252809 | | | Device Name in2 Smart (in2S) | | | Indications for Use (Describe) The in2 Smart is indicated for management of premature ejaculation in males who ejaculate after intromission. It is designed to increase the time between arousal and ejaculation by delivery of short duration, low-intensity electrical stimulation to the perineal muscles and nerves during intercourse. | | | 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} K252809 Page 1 of 4 VIRILITY MEDICAL in2 Smart 510(k) Submission 510(k) Summary DATE PREPARED: September 01, 2025 510(k) Summary [as required by section 807.92] in2 Smart Submitter: MANUFACTURER AND 510(k) OWNER: Virility Medical Ltd. 24 Hanagar St. Hod-Hasharon 4527713 Israel Phone: +972 54-542-1982 PRIMARY CONTACT: Natalie Shukrun, Director of Quality Assurance & Regulatory Affairs Phone: +972 52-892-6339 Email: natalie@virilitymedical.com Device Identification: Trade Name: in2 Smart (in2S) Common Name: Non-Implanted Electrical Stimulation Device for Management of Premature Ejaculation Classification: Name: Non-Implanted Electrical Stimulation Device for Management of Premature Ejaculation Product Code: QRC Regulation No: 876.5026 Class: 2 Medical Specialty: Gastroenterology/Urology Review Panel: GastroRenal, ObGyn, General Hospital, and Urology Devices (OHT3) Reproductive, Gynecology and Urology Devices (DHT3B) IN2 thein2.com 24 Hanagar St., Hod Hasharon, 4527713 Israel info@virilitymedical.com +972-54-5421982 Page 2 of 5 {5} K252809 Page 2 of 4 VIRILITY MEDICAL) in2 Smart 510(k) Submission 510(k) Summary ## Predicate Device Identification: The in2 Smart is substantially equivalent to the following primary predicate: vPATCH, manufactured by Virility Medical Ltd., 510(k) Number: K223595; Product Code: QRC. This predicate device has not been subject to a design-related recall. ## Device Description: The in2 Smart device is a wearable, hybrid design for the management of premature ejaculation. It includes reusable components for electrical stimulation generation and control, combined with disposable Contact Pads that deliver electrical muscle stimulation (EMS) to the perineal muscles during intercourse to help the user delay ejaculation. The device operates by delivering short-duration, low-intensity EMS to the perineal muscles and nerves, contracting pelvic floor muscles and thereby delaying the rhythmic contractions associated with ejaculation, increasing time between arousal and ejaculation. The stimulation intensity is user-adjustable within a clinically proven safe range. Skin-contacting materials on the disposable Contact Pads include hydrogel and biocompatible electrode layers. Its technological characteristics and principles of operation are substantially equivalent to the predicate device, Virility Medical’s vPATCH (K223595), ensuring comparable safety and effectiveness within the intended use. ## Indications for Use: The in2 Smart device is indicated for management of premature ejaculation in males who ejaculate after intromission. It is designed to increase the time between arousal and ejaculation by delivery of short duration, low-intensity electrical stimulation to the perineal muscles and nerves during intercourse. Page 3 of 5 thein2.com 24 Hanagar St., Hod Hasharon, 4527713 Israel info@virilitymedical.com +972-54-5421982 {6} K252809 Page 3 of 4 # VIRILITY MEDICAL in2 Smart 510(k) Submission 510(k) Summary ## Comparison of Technological Characteristics: Virility Medical believes that the in2 Smart is substantially equivalent to the predicate devices vPATCH (K223595) based on the information summarized here: - The in2 Smart device has the same intended use and indication as the predicate device cleared under K223595, namely a non-implanted electrical stimulation device for managing premature ejaculation. - Both the in2 Smart and the predicate device are applied to the perineum prior to intercourse and activated to induce stimulation. - The in2 Smart and the predicate device operate on the same clinical principles. - Both the subject device and the predicate (K223595) are non-sterile and include a single-use component. ## Substantial Equivalence The following table provides a comparison with the predicate: | Device Name (Manufacturer) Feature | Subject Device in2 Smart (Virility Medical, Ltd.) | Predicate Device vPATCH (K223595) (Virility Medical, Ltd.) | | --- | --- | --- | | Reg. Number | 876.5026 | 876.5026 | | Product Code | QRC | QRC | | Indication for Use | The in2 Smart is indicated for management of premature ejaculation in males who ejaculate after intromission. It is designed to increase the time between arousal and ejaculation by delivery of short duration, low-intensity electrical stimulation to the perineal muscles and nerves during intercourse. | The vPatch is indicated for management of premature ejaculation in males who ejaculate after intromission. It is designed to increase the time between arousal and ejaculation by delivery of short duration, low-intensity electrical stimulation to the perineal muscles and nerves during intercourse. | | Type of Use | OTC | OTC | | Principle of Operation | Patch is applied to the perineum prior to intercourse and switched on to induce stimulation. | Patch is applied to the perineum prior to intercourse and switched on to induce stimulation. | | Biocompatibility | The in2 Smart underwent cytotoxicity, sensitization and irritation testing. | The vPATCH underwent cytotoxicity, sensitization and irritation testing. | # thein2.com 24 Hanagar St., Hod Hasharon, 4527713 Israel # info@virilitymedical.com # +972-54-5421982 {7} K252809 Page 4 of 4 # VIRILITY MEDICAL in2 Smart 510(k) Submission ## 510(k) Summary | Device Name (Manufacturer) Feature | Subject Device in2 Smart (Virility Medical, Ltd.) | Predicate Device vPATCH (K223595) (Virility Medical, Ltd.) | | --- | --- | --- | | Single use | Contact Pad: Single use | Single use device | | Sterility | Not sterile | Not sterile | | Packaging Configuration | in2 Smart kit includes 1 multiple use Smart Pod, 1 multiple use Smart Case, 10 single-use disposable Contact Pads and 1 Power Cable, along with an IFU. | Available in two package configurations for high and low intensities; each package type contains 4 patches of the same intensity. | | Stimulation Current | Can be personalized by the user, between Low and High intensities: LOW Intensity: 9.9mA±10% HIGH Intensity: 14.3mA±10% | Available in two pre-configured stimulations: LOW Intensity: 9.9mA±10% HIGH Intensity: 14.3mA±10% | | Maximal Stimulation Duration | 30 minutes | 15 minutes | Any differences in technological characteristics do not raise different questions of safety or effectiveness. ## Summary of Non-Clinical Testing Hardware physical and functional testing was completed, including basic electrical safety and EMC testing. Software verification and validation testing were conducted in accordance with IEC 62304:2006+A1:2015. Usability testing was performed following applicable standards and demonstrated that the device is safe, effective, and user-friendly for its intended users. Biocompatibility testing on the in2 Smart was carried out to demonstrate conformity with ISO 10993-1:2018. ## Conclusion Based on the Substantial Equivalence summary provided above, it is evident that the in2 Smart and the predicate device, vPATCH (K223595), share the same intended use/indications for use and similar technological characteristics and principles of operation. Any differences between the in2 Smart device and its predicate do not present any new issues of safety or effectiveness, as demonstrated by the performance tests, bench tests and usability study conducted on the subject device, and as compared to the predicate. in2 thein2.com 24 Hanagar St., Hod Hasharon, 4527713 Israel info@virilitymedical.com +972-54-5421982 Page 5 of 5 --- **Source:** [https://fda.innolitics.com/device/K252809](https://fda.innolitics.com/device/K252809) **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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