BTL-299-F
Device Facts
| Record ID | K262353 |
|---|---|
| Device Name | BTL-299-F |
| Applicant | BTL Industries, Inc. |
| Product Code | KPI · Gastroenterology, Urology |
| Decision Date | Sep 23, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5320 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The device 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. The device is intended to provide electromagnetic stimulation for the treatment of fecal incontinence in male and female patients.
Device Story
BTL-299-F is a non-invasive therapeutic device for pelvic floor muscle rehabilitation; utilizes electromagnetic field generation to induce muscle contraction via nerve stimulation. System comprises a main unit with touchscreen interface and an air-cooled applicator (chair form factor). Operated by clinicians in a professional setting; therapy is applied through clothing. User follows on-screen guidance to set parameters; device displays therapy progress and remaining time. Electromagnetic field interacts with pelvic/rectal tissue to trigger tonisation; intended to restore neuromuscular control and treat incontinence. Benefits include non-invasive muscle stimulation as an alternative to voluntary effort.
Clinical Evidence
Clinical experiment conducted to evaluate the device's ability to non-invasively induce anal sphincter contractions comparable to voluntary effort. Results demonstrated the device is capable of activating anal sphincter muscles via electromagnetic stimulation, supporting its use for rectal region muscle stimulation.
Technological Characteristics
Non-invasive electromagnetic stimulator. Main unit includes electromagnetic field generator, computer, and touchscreen. Applicator contains air-cooled stimulation coil. Energy: 100–240 V AC. Magnetic field intensity: 0.7–2.5 T. Pulse rate: 1–150 Hz. Pulse width: 280 μs. Standards: IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 14971, ISO 10993-1. Chair applicator load capacity: 330 lb (150 kg).
Indications for Use
Indicated for male and female patients requiring rehabilitation of weak pelvic muscles, restoration of neuromuscular control for urinary incontinence, or treatment of fecal incontinence.
Regulatory Classification
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)
Reference Devices
- INTONEMV (K134020)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
September 23, 2026
BTL Industries, Inc.
David Chmel
CEO North America
362 Elm St.
Marlborough, Massachusetts 01752
Re: K262353
Trade/Device Name: BTL-299-F
Regulation Number: 21 CFR 876.5320
Regulation Name: Nonimplanted Electrical Continence Device
Regulatory Class: Class II
Product Code: KPI
Dated: July 10, 2026
Received: July 10, 2026
Dear David Chmel:
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" (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).
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K262353 - David Chmel
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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 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,
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K262353 - David Chmel
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# STEPHANIE COLE -S
*for*
Anthony Lee, Ph.D., M.B.A.
Assistant Director
DHT3A: Division of Renal, Gastrointestinal, Obesity, and Transplant 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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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K262353 | ? |
| Please provide the device trade name(s). | | ? |
| BTL-299-F | | |
| Please provide your Indications for Use below. | | ? |
| The device 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.The device is intended to provide electromagnetic stimulation for the treatment of fecal incontinence in male and female patients. | | |
| Please select the types of uses (select one or both, as applicable). | Prescription Use (21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| Please select the age group(s) for which the device(s) is to be used. | Neonates/Newborns (Birth to < 29 days old)Infants (29 days old to < 2 years old)Children (2 years old to < 12 years old)Adolescents (12 years old to < 22 years old)Adults (22 years old and greater) | ? |
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K262353 - Page 1/6
BTL Industries
## 510(k) Summary
K262353
### General Information
| Sponsor: | BTL Industries, Inc. 362 Elm Street Marlborough, MA 01752 Tel: +1-866-285-1656 Fax: +1-888-499-2502 |
| --- | --- |
| Applicant: | BTL Industries, Inc. 362 Elm Street Marlborough, MA 01752 Tel: +1-866-285-1656 Fax: +1-888-499-2502 |
| Contact Person: | David Chmel BTL Industries, Inc. chmel@btlnet.com |
| Summary Preparation Date: | July 3, 2026 |
### Device
| Trade/Proprietary Name: | BTL-299-F |
| --- | --- |
| Common Name: | Stimulator, Electrical, Non-Implantable, For Incontinence |
| Primary Classification Name: | Nonimplanted electrical continence device |
| Classification Regulation: | 21 CFR 876.5320, Class II |
| Classification Product Code: | KPI |
510(k) Summary
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BTL Industries
### Legally Marketed Predicate/Reference Devices
The BTL-299-F is substantially equivalent to the following predicate device that is already cleared for distribution in the USA under the following 510(k) Premarket Notification number:
Predicate Device:
HPM-6000UF
Original 510(k) Sponsor: BTL Industries, Inc.
510(k) Number: K181497
Reference Device:
INTONEMV
Original 510(k) Sponsor: InControl Medical, LLC
510(k) Number: K134020
### Product Description
The BTL-299-F is a non-invasive therapeutic device. The device produces electromagnetic field that interacts with tissues of the human body. The electromagnetic field delivered in the muscular or neuronal tissue area is triggering stimulation and tonisation.
The BTL-299-F consists of a main unit and one connected applicator. The main unit is equipped with a color touchscreen with a wide viewing angle, which significantly facilitates use of the device. The on-screen information guides the user step by step through the entire therapy procedure.
The therapeutic parameters can be set using the touchscreen, buttons, and knob on the device. During therapy, the device displays information about the applied therapy, the remaining therapy time, and the main therapy parameters. Therapy is applied through clothing.
### Indications for Use
The device 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.
The device is intended to provide electromagnetic stimulation for the treatment of fecal incontinence in male and female patients.
### Technological Characteristics
The BTL-299-F is identical in design to the HPM-6000UF predicate device. The only difference compared to this predicate device is the expansion of the indications for use statement.
The BTL-299-F and its predicate device consist of a main unit and an applicator. The main unit includes an electromagnetic field generator, a computer, and the touchscreen control panel. The applicators are designed for non-invasive treatment of incontinence. The stimulation coil is located in the center of each applicator and is air-cooled. The chair applicator is designed for a therapy of muscles in targeted area.
510(k) Summary
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BTL Industries
The coil is located in the middle of the seat and air cooled. For precise patient positioning the seat height can be electronically adjusted.
## Non-clinical Testing (Performance, Bench Testing)
The BTL-299-F has been thoroughly evaluated for electrical safety. The device has been found to comply with applicable medical device safety standards:
| IEC 60601-1 | Medical electrical equipment – Part 1: General requirements for basic safety and essential performance |
| --- | --- |
| IEC 60601-1-2 | Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances – Requirements and tests |
| IEC 62304 | Medical device software – Software life cycle processes |
| ISO 14971 | Medical devices – Application of risk management to medical devices |
| ISO 10993-1 | Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process |
Bench testing, conducted during final quality control of each unit, verified the maximum load capacity of the chair applicator 330 lb (150 kg).
## Clinical Testing
To demonstrate the comparability of electromagnetic stimulation with voluntary effort and electrical stimulation of neuromuscular tissue, a clinical experiment was conducted to evaluate the device's ability to non-invasively induce anal sphincter contractions comparable to voluntary effort.
The results demonstrate that the device is capable of activating the anal sphincter muscles via electromagnetic stimulation. These findings support the potential use of electromagnetic stimulation as a method for stimulation muscles in the rectal region.
510(k) Summary
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BTL Industries
## Comparison with the Predicate Device
| **510(k) number** | **K262353** | **K181497** | **K134020** |
| --- | --- | --- | --- |
| **Device name** | BTL-299-F | HPM-6000UF | InToneMV |
| **Company name** | BTL Industries, Inc. | BTL Industries, Inc. | InControl Medical, LLC |
| | Subject device | Predicate device | Reference device |
| **Product Code and Regulation** | Gastroenterology-Urology Devices 21 CFR 876.5320 KPI – Stimulator, Electrical, Non-Implantable, For Incontinence | Gastroenterology-Urology Devices 21 CFR 876.5320 KPI – Stimulator, Electrical, Non-Implantable, For Incontinence | Gastroenterology-Urology Devices 21 CFR 876.5320 KPI – Stimulator, Electrical, Non-Implantable, For Incontinence |
| **Intended Use** | The device 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. The device is intended to provide electromagnetic stimulation for the treatment of fecal incontinence in 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. | InToneMV is intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of male and female urinary and fecal incontinence. |
| **Clinical Use** | Prescription Use | Prescription Use | Clinic or home use, under direction of physician |
| **Applicable Patients** | Man and Woman | Man and Woman | Man and Woman |
| **Primary Function** | Muscle stimulation | Muscle stimulation | Muscle stimulation |
510(k) Summary
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| Principle of Action | Initiating action potential of nerves results in muscle contraction | Initiating action potential of nerves results in muscle contraction | Initiating action potential of nerves results in muscle contraction |
| --- | --- | --- | --- |
| Type of Energy | Magnetic field | Magnetic field | Direct Electrical stimulation |
| Energy Source | 100 – 240 V AC, 50 – 60 Hz | 100 – 240 V AC, 50 – 60 Hz, max 14 A | 4/5 AA nickel metal hydride battery |
| Number of Output Channels | 1 | 1 | 1 |
| Magnetic Field Intensity | 0.7 – 2.5 T | 0.7 – 2.5 T | N/A |
| Pulse Repetition Rate | 1 – 150 Hz | 1 – 150 Hz | 0 - 50 Hz |
| Pulse Width | 280 μs (± 20%) | 280 μs (± 20%) | 200 μs |
| Shape of Stimulation Pulse | Biphasic, sine | Dual phase, rectangular pulses | Dual phase, rectangular pulses |
| Number of Applicators | 2 | 1 | 1 |
| Therapy Time | Up to 30 min | Up to 30 min | Up to 30 min |
| Interface | Touch-screen | Touch-screen | Buttons accompanied by simple screen |
| Firmware Controlled | Yes | Yes | Yes |
| Environmental Specifications | For indoor use only | For indoor use only | For indoor use only |
| Operating Temperature | +10 to +30 °C (50 – 86 °F) | +10 to +30 °C (50 – 86 °F) | Unknown |
| Main Unit Dimensions (W×H×D) | 500 × 970 × 580 mm (20 × 38 × 23 in) | 500 × 970 × 580 mm (20 × 38 × 23 in) | 122 x 61 x 30 mm (4.8 x 2.4 x 1.1 in) |
| Main Unit Weight | 46 kg (101 lb) | 46 kg (101 lb) | Unknown |
510(k) Summary
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### Substantial Equivalence
The technological characteristics of BTL-299-F are the same as its predicate device HPM-6000UF device. The differences between the predicate, reference and BTL-299-F devices have no significant influence on safety and effectiveness of the BTL-299-F. Therefore, the BTL-299-F is substantially equivalent to the predicate devices.
### Conclusion
Based upon the intended use and known technical information provided in this pre-market notification, the BTL-299-F device has been shown to be substantially equivalent to currently marketed predicate devices.
510(k) Summary
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