(203 days)
No
The document describes the device's functionality as electrostimulation and radiofrequency therapy guided by a touchscreen interface, with no mention of AI, machine learning, or deep learning.
Yes
The device's intended use is to "relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain, muscle re-education, increasing blood flow, and maintain or increase mandibular range of motion," which are all therapeutic benefits.
No
The device is described as an "electrostimulation and radiofrequency platform" intended for therapy, such as relieving symptoms, muscle re-education, and increasing blood flow. Its stated indications are therapeutic, not diagnostic.
No
The device description clearly outlines numerous hardware components including a handpiece, holding arm, connection cables, single-use applicators, and a therapy discomfort button, in addition to the main unit and control unit. It is a physical electrostimulation and radiofrequency platform, not purely software.
No
The device description and intended use indicate that it is a therapeutic device that applies electrostimulation and radiofrequency to the human body for treatment purposes, not a device used in vitro on specimens for diagnostic information.
N/A
Intended Use / Indications for Use
The BTL-785MJ device with the controller and single-use applicators has the following indications for use:
- To relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain
- Muscle re-education
- Increasing blood flow
- Maintain or increase mandibular range of motion
Product codes (comma separated list FDA assigned to the subject device)
NUW, NFO
Device Description
The BTL-785MJ is a state-of-the-art electrostimulation and radiofrequency platform with accessories that enables the application of therapy by electrical stimulation.
The control unit of the system is equipped with a large color touch screen that facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are set using the touch screen of the device. During the therapy the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
The generated electromagnetic field is intended to interact with the tissues of the human body in order to relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain, muscle re-education, increase blood flow and maintain or increase mandibular range of motion.
The BTL-785MJ device consists of the following main components:
- Main unit
- Handpiece
- Holding arm
- Connection cables
- Single-use applicators
- Therapy discomfort button
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
A clinical study was not conducted.
The BTL-785MJ device 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 60601-2-10 Medical electrical equipment – Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
IEC 60601-1-6 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
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
ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
ISO 10993-10 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
FDA Clearance Letter for BTL-785MJ
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
May 9, 2025
BTL Industries, Inc.
David Chmel
CEO North America
362 Elm Street
Marlborough, Massachusetts 01752
Re: K243290
Trade/Device Name: BTL-785MJ
Regulation Number: 21 CFR 890.5850
Regulation Name: Powered Muscle Stimulator
Regulatory Class: Class II
Product Code: NUW, NFO
Dated: October 18, 2024
Received: April 10, 2025
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.
Page 2
K243290 - David Chmel 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. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
Page 3
K243290 - David Chmel Page 3
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,
MICHAEL E. ADJODHA -S
Michael E. Adjodha, MChE, RAC, CQIA
Assistant Director
DHT1B: Division of Dental and
ENT Devices
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
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.
Submission Number (if known)
K243290
Device Name
BTL-785MJ
Indications for Use (Describe)
The BTL-785MJ device with the controller and single-use applicators has the following indications for use:
- To relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain
- Muscle re-education
- Increasing blood flow
- Maintain or increase mandibular range of motion
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."
Page 5
510(k) Summary
Page 1 of 6
510(k) Summary – K243290
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: May 08, 2025
Device
Trade/Proprietary Name: BTL-785MJ
Common Name: Stimulator, muscle, powered, dental
Primary Classification Name: Powered muscle stimulator
Classification Regulation: 21 CFR 890.5850, Class II
Primary Product Code: NUW
Secondary Product Code: NFO
Page 6
510(k) Summary
Page 2 of 6
Legally Marketed Predicate Device
The BTL-785MJ is substantially equivalent to the following product(s) that are already cleared for distribution in the USA under the following 510(k) Premarket Notification numbers:
Primary predicate:
Device name: D function
Original 510(k) Sponsor: ITO CO., LTD.
510(k) Number: K203525
Reference device:
Device name: BTL-785BNF-E
Original 510(k) Sponsor: BTL Industries, Inc.
510(k) Number: K242532
Product Description
The BTL-785MJ is a state-of-the-art electrostimulation and radiofrequency platform with accessories that enables the application of therapy by electrical stimulation.
The control unit of the system is equipped with a large color touch screen that facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are set using the touch screen of the device. During the therapy the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
The generated electromagnetic field is intended to interact with the tissues of the human body in order to relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain, muscle re-education, increase blood flow and maintain or increase mandibular range of motion.
The BTL-785MJ device consists of the following main components:
- Main unit
- Handpiece
- Holding arm
- Connection cables
- Single-use applicators
- Therapy discomfort button
Page 7
510(k) Summary
Page 3 of 6
Indications for Use
The BTL-785MJ device with the controller and single-use applicators has the following indications for use:
- To relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain
- Muscle re-education
- Increasing blood flow
- Maintain or increase mandibular range of motion
Non-clinical Testing (Performance Data)
The BTL-785MJ device 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 60601-2-10 Medical electrical equipment – Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
IEC 60601-1-6 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
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
ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
ISO 10993-10 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
Clinical performance data
A clinical study was not conducted.
Page 8
510(k) Summary
Page 4 of 6
Comparison with the Predicate Device
| 510(k) number | K243290 | K203525 | K242532 |
|---|---|---|---|
| Device name | BTL-785MJ | D function | BTL-785BNF-E |
| Company name: | BTL Industries, Inc. | ITO CO., LTD. | BTL Industries, Inc. |
| Type | Subject device | Predicate device | Reference device |
| Product Code and Regulation | Physical medicine | ||
| Dental | |||
| 21 CFR 890.5850 | |||
| NUW – Stimulator, Muscle, Powered, Dental | Physical medicine | ||
| Dental | |||
| 21 CFR 890.5850 | |||
| NUW – Stimulator, Muscle, Powered, Dental | Neurology | ||
| Neurology | |||
| 21 CFR 882.5890 | |||
| NFO – Stimulator, Transcutaneous Electrical, Aesthetic Purposes | |||
| Indications for Use | The BTL-785MJ device with the controller and single-use applicators has the following indications for use: |
- To relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain
- Muscle re-education
- Increasing blood flow
- Maintain or increase mandibular range of motion | 1) To relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain
- Muscle re-education
- Increasing blood flow
- Maintain or increase mandibular range of motion | The BTL-785BNF-E device has the following indications for use:
The device is indicated for aesthetic use including facial and neck or body skin stimulation. |
| Principle of Action | Electrostimulation | Electrostimulation | Electrostimulation |
| Clinical Use | Prescription use | Prescription use | Prescription use |
Page 9
510(k) Summary
Page 5 of 6
| Energy Source | 100 – 120 V AC, 50/60 Hz
200 – 240 V AC, 50/60 Hz | AC 100-240V, 50/60Hz
DC 12 V (AC adaptor)
DC 7.4 (Lithium ion battery) | 100 – 120 V AC, 50/60 Hz
200 – 240 V AC, 50/60 Hz |
|---------------|----------------------------------------|----------------------------------------|----------------------------------------|
| Electrical Safety & EMC Testing | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-10 | ANSI AAMI 60601-1
IEC 60601-1-2
IEC 60601-2-10 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-10 |
| Energy Type | Electric stimulation | Electric stimulation | Electric stimulation |
| Accessory Attachment Method | Pad – single-use applicator | Pad – single-use applicator | Pad – single-use applicator |
| Therapy time | 20-60 minutes | 60 minutes (Up to 480 min) | 20 minutes |
| Pulse Width | Preset 1: Up to 150 μs
Preset 2: 488 μs | PAIN: Up to 150μs
CARE: 488 μs
MCR: 150ms | 160 µs |
| Output Frequency (Hz) | Preset 1: Up to 200
Preset 2: 0.67 | PAIN: Up to 200
CARE: 0.67
MCR: 400 | 250 |
| Output Current | Preset 1 : Up to 80 mA
Preset 2: Up to 80 mA | PAIN: Up to 80 mA
CARE: 24 mA
MCR: 750 μA | Up to 130 mA |
| Max. Output Voltage [V] | BTL-785-7-2, -8
48,5V @ 500 Ω
48,5V @ 2000 Ω
0 @ 10 000 Ω | Not publicly available | BTL-785-7-2, -8
48,5V @ 500 Ω
48,5V @ 2000 Ω
0 @ 10 000 Ω |
| Max. Current density at 500 Ω [µA/mm²] | BTL-785-7-2 – 200 µA/mm²
BTL-785-7-8 -276 µA/mm² | Not publicly available | BTL-785-7-2 – 243 µA/mm²
BTL-785-7-8 - 335 µA/mm² |
| Max average power density at 500 Ω [W/cm²] | BTL-785-7-2 – 0,058 W/cm²
BTL-785-7-8 -0.082 W/cm² | Not publicly available | BTL-785-7-2 – 0,047 W/cm²
BTL-785-7-8 - 0,065 W/cm² |
| Pulse Shape | Rectangular | Rectangular | Rectangular |
| Channel Numbers | 2 | 2 | Up to 3 |
Page 10
510(k) Summary
Page 6 of 6
| Electrical Safety Class | Class II, BF | Class II, BF | Class II, BF |
|---|---|---|---|
| Timer | Yes | Yes | Yes |
| Buzzer | Yes | Yes | Yes |
| Display | Yes | Yes | Yes |
| (a) Electrodes materials | |||
| (b) Electroconductive media | |||
| (c) electrode-to-skin impedance range | |||
| (d) conductive surface area | a) Conductive ink (Silver) | ||
| b) Conductive hydrogel | |||
| c) 10-5000 Ohm | |||
| d) BTL-785-7-2 - 4 cm² | |||
| BTL-785-7-8 - 2.9 cm² | a) Not publicly available | ||
| b) Not publicly available | |||
| c) Not publicly available | |||
| d) Not publicly available | a) Conductive ink (Silver) | ||
| b) Conductive hydrogel | |||
| c) 10-5000 Ohm | |||
| d) BTL-785-7-2 - 4 cm² | |||
| BTL-785-7-8 - 2.9 cm² | |||
| System Weight | 65 kg | ||
| (143 lb) | 230 g | ||
| (0.5 lb) | 65 kg | ||
| (143 lb) | |||
| System Dimensions (W×H×D) | 53.94" x 26.38" x 26.38" | 3.3" x 0.93" x 5.9" | 53.94" x 26.38" x 26.38" |
Substantial Equivalence
The BTL-785MJ device has similar technological characteristics and the same intended use compared to the primary predicate device and comparable mode of action and intended use compared to reference device. Any differences between the predicate device and BTL-785MJ device have no significant influence on safety or effectiveness of the BTL-785MJ device.
Therefore, the BTL-785MJ device is substantially equivalent to the predicate device.
Conclusion
Based upon the intended use, comparison of technical characteristics and performance testing provided in this premarket notification, the BTL-785MJ device has been shown to be substantially equivalent to the currently cleared predicate device for requested intended use.