Quantum Mitohormesis (QMT) (M2101)

{0}------------------------------------------------ December 19, 2024 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION". QuantumTX Pte. Ltd. Ivan Goh CEO 378 Alexandra Road, Alexandra Hospital, Block 29, CIH Co-Working Space Level 1 Singapore, 159964 Singapore Re: K240348 Trade/Device Name: Quantum Mitohormesis (QMT) (M2101) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, NGX Dated: November 21, 2024 Received: November 21, 2024 Dear Ivan Goh: 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" {1}------------------------------------------------ (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 OS 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 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-reportingcombination-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 Rue"). 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-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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). {2}------------------------------------------------ Sincerely, # Jitendra V. Virani -S CDR Jitendra Virani Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ #### Indications for Use Submission Number (if known) K240348 Device Name Quantum Mitohormesis (QMT) (M2101) Indications for Use (Describe) Quantum Mitohormesis Medical Device is intended for: - · Stimulating healthy limb muscles to improve and facilitate muscle performance. - · Preventing or retardation of disuse atrophy of muscles. 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}------------------------------------------------ 510(k) summary of Safety and Effectiveness for Quantum Mitohormesis (QMT) is provided in accordance with 21 CFR 890 5850. | Date: | 12 Jan, 2024 | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter (Owner): | QuantumTX Pte. Ltd.<br>298 Tiong Bahru Rd.,<br>Central Plaza, #20-06, Singapore168730<br>ivangoh@quantumtx.com | | 510(k) Contact Person: | Ivan Goh | | Device Trade Name: | Quantum Mitohormesis (QMT) (M2101) | | Regulation Number: | 21 CFR 890.5850 | | Regulation Name: | Powered Muscle Stimulator | | Classification Panel: | Physical Medicine | | Device Class: | Class II | | Product Code: | IPF, NGX | | Primary Predicate Device: | Bemer Classic & Pro (K151834)<br>Regulation number: 21 CFR 890.5850<br>Regulation Name: Powered Muscle Stimulator<br>Device class: II<br>Product code: NGX<br>Review panel: Physical Medicine | | Secondary Predicate Device: | Storz Medical MAGNETOLITH Muscle Stimulator (K203710)<br>Regulation number: 21 CFR 890.5850<br>Regulation Name: Powered Muscle Stimulator<br>Device class: II<br>Product code: IPF, NGX<br>Review panel: Physical Medicine | {5}------------------------------------------------ #### Indications for Use: Quantum Mitohormesis Medical Device is intended for: - Stimulating healthy muscles to improve and facilitate muscle performance. . - Preventing or retardation of disuse atrophy of muscles. ● #### Description of the Device: Quantum Mitohormesis (QMT) is a medical device that uses unique pulsed electromagnetic fields for muscle therapy. Users (adults ≥ 22 years old) place one group of muscles in the lower limbs into the field applicator of QMT device, which for a defined duration generates specific electromagnetic fields that stimulates healthy muscles to improve and facilitate muscle performance, and prevents and retards muscle disuse atrophy. QMT is applied directly to muscles (without direct contact) to stimulate muscle activity. In order to achieve optimized treatment outcome, QMT is applied to muscles on a weekly basis, once or twice a week, with each treatment application lasting a brief 10-minutes. The device consists of the following high-level components: - Base unit, which includes signal generator, power amplifier, and micro-controller unit. a) - b) Field applicator, which includes electro-magnetic coils generating specific magnetic pulses. - User Interface Panel, which allows users to operate the device and display necessary c) device information. - d) Signal cord. - Height and tilt adjustment knobs, which allow users to adjust the height and tilt of field e) applicator; and {6}------------------------------------------------ | Model Name | Model No. | Model Description | |-------------------------------|-----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Quantum Mitohormesis<br>(QMT) | M2101 | Quantum Mitohormesis (QMT) Model M2101, is a medical device that uses unique pulsed electromagnetic fields for muscle therapy. It is intended to stimulate healthy muscles to improve and facilitate muscle performance and prevent or retard disuse atrophy of muscles.<br><br>The following components are included in the device packing: QMT Device (1), Power Cord (1), Instruction for Use (1). | The model numbers included in the submission are indicated below: {7}------------------------------------------------ Quantum Mitohormesis (QMT) (M2101) 510(k) Summary Abbreviated 510(k): K240348 ## Comparison to Predicate Devices: Two predicate devices are selected in this substantial equivalence discussion of Quantum Mitohormesis. Predicate device 1: Storz Medical MAGNETOLITH Muscle Stimulator (K203710) Predicate device 2: Bemer Classic & Pro (K151834) | Parameter | Subject Device | Predicate Device 1 | Predicate Device 2 | Comparison | |--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device name | Quantum Mitohormesis | Storz Medical MAGNETOLITH<br>Muscle Stimulator | Bemer Classic & Pro | | | 510(k) number | Not registered | K203710 | K151834 | | | Manufacturer | QuantumTX Pte. Ltd.<br>298 Tiong Bahru Rd.,<br>Central Plaza, #20-06,<br>Singapore168730 | Biomed Research, Inc.<br>3959 Van Dyke Road.,<br>Suite 245,<br>Lutz, Florida 33558, United<br>States. | BEMER Int. AG<br>Austrasse 15<br>Triesen, 9495 Liechtenstein | | | Regulation number | 21 CFR 890.5850 | 21 CFR 890.5850 | 21 CFR 890.5850 | Identical | | Product code | IPF - Stimulator, Muscle,<br>Powered<br>NGX - Stimulator, Muscle,<br>Powered | IPF - Stimulator, Muscle,<br>Powered<br>NGX - Stimulator, Muscle,<br>Powered | NGX - Stimulator, Muscle,<br>Powered | Identical | | Product class | II | II | II | Identical | | Intended use/<br>indication | • Stimulating healthy limb<br>muscles to improve and<br>facilitate muscle performance. | • Relaxation of muscle<br>spasms | • To temporarily increase local<br>blood circulation in healthy leg<br>muscles | Identical | | Parameter | Subject Device | Predicate Device 1 | Predicate Device 2 | Comparison | | Device name | Quantum Mitohormesis | Storz Medical MAGNETOLITH<br>Muscle Stimulator | Bemer Classic & Pro | | | | • Preventing or retardation of<br>disuse atrophy of muscles. | • Prevention or retardation of<br>disuse atrophy<br>• Increasing local blood<br>circulation<br>• Muscle re-education<br>• Immediate post-surgical<br>stimulation of calf muscles to<br>prevent venous thrombosis<br>• Maintaining or increasing<br>range of motion<br>• To stimulate healthy muscles<br>in order to improve and<br>facilitate muscle<br>performance | • To stimulate healthy muscles in<br>order to improve and facilitate<br>muscle performance | | | Principle of action | Non- invasive tissue stimulation<br>via magnetic field induction | Non- invasive tissue stimulation<br>via magnetic field induction | Non- invasive tissue stimulation via<br>magnetic field induction | Identical | | Clinical use | Prescription use | Prescription use | Over the counter use | | | Electrical protection | Class I, B | Class I, B | unknown | Identical | | User interface | Buttons | Touch Screen | Touch Screen | Minor difference, no impact<br>on safety and effectiveness. | | Firmware controlled | Yes | Yes | Yes | Identical | | Parameter | Subject Device | Predicate Device 1 | Predicate Device 2 | Comparison | | Device name | Quantum Mitohormesis | Storz Medical MAGNETOLITH<br>Muscle Stimulator | Bemer Classic & Pro | | | Type of energy | Magnetic field | Magnetic field | Magnetic field | Identical | | Number of outputs | 1 | 1 | 2 | Identical | | Number of magnetic<br>coils in the<br>applicator | 3 | 1 | unknown | Minor difference, no impact<br>on safety and effectiveness. | | Magnetic field<br>intensity | Standard Mode amplitude: 1.0mT<br>±10%<br>Pro Mode amplitude: 1.3mT<br>±10% | 0.4T ±20% at surface<br>0.08T ±20% at center of coil | 35-100 µT | Minor difference, no impact<br>on safety and effectiveness. | | Pulse repetition rate | 3.3 kHz | 1-10 Hz | 10-30 Hz | 3.3 kHz electromagnetic<br>pulses are applied as 6 ms<br>bursts with a repetition rate<br>of 50 Hz. Performance<br>testing show comparative<br>safety and effectiveness<br>profile. | | Pulse duration | 150 µs | 125µs ± 20% | 10-33 μs | Minor difference, no impact<br>on safety and effectiveness. | | Therapy time | 10 minutes | 10-20 minutes | 20 minutes | Identical | | Energy source | 100 - 240 VAC 50-60Hz | 100 - 240 VAC 50-60Hz | 100 - 240 VAC, 50/60 Hz | Identical | | Parameter | Subject Device | Predicate Device 1 | Predicate Device 2 | Comparison | | Device name | Quantum Mitohormesis | Storz Medical MAGNETOLITH<br>Muscle Stimulator | Bemer Classic & Pro | | | System dimensions<br>(w×h×d) | 565 x 565 x 705mm | 454 x 187 x 460 mm | 320 x 320 x 70 mm | Difference in dimension<br>does not impact safety and<br>effectiveness. | | Ambient<br>temperature | 5 – 35 °C | 10° – 30°C | 10° - 30°C | | | Relative humidity | 15 - 90 % (non-condensing) | 5-55% | unknown | | | Environmental<br>specifications | For indoor use only | For indoor use only | For indoor use only | Identical | | Biocompatibility | EN ISO 10993-1: 2018 Biological<br>Evaluation of Medical Devices<br>Part 1: Evaluation and Testing | Not applicable | EN ISO 10993-1: 2009 Biological<br>Evaluation of Medical Devices Part<br>1: Evaluation and Testing | | | Preclinical testing | IEC 60601-1:2020: Medical<br>Electrical Equipment - Part 1:<br>General Requirements For<br>Basic Safety And Essential<br>Performance IEC 60601-1-2:2014: Medical<br>Electrical Equipment - Part 1-<br>2: General Requirements For<br>Basic Safety And Essential<br>Performance - Collateral<br>Standard: Electromagnetic<br>Disturbances - Requirements<br>And Tests | IEC 60601-1:2012, (Ed. 3.1):<br>Medical electrical equipment<br>– Part 1: General<br>requirements for basic safety<br>and essential performance. IEC 60601-1-2: 2014 (4th<br>Ed.): Medical electrical<br>equipment - Part 1-2:<br>General requirements for<br>basic safety and essential<br>performance - Collateral<br>standard: Electromagnetic | IEC/EN 60601-1:2007 Medical<br>Electrical Equipment, Part 1,<br>General Requirements for<br>Safety IEC 60601-1-2:2014 Medical<br>Electrical Equipment, Part 1-2,<br>General Requirement for<br>Safety, Electromagnetic<br>Compatibility IEC/EN 60601-1-4:2001<br>Medical Electrical Equipment,<br>Part 1-4, Collateral Standard: | | | Parameter | Subject Device | Predicate Device 1 | Predicate Device 2 | Comparison | | Device name | Quantum Mitohormesis IEC TR 60601-4-2: 2016:<br>Medical electrical equipment -<br>Part 4-2: Guidance and<br>interpretation -<br>Electromagnetic immunity:<br>performance of medical<br>electrical equipment and<br>medical electrical systems IEC 60601-1-6: 2020: Medical<br>electrical equipment - Part 1-<br>6: General requirements for<br>basic safety and essential<br>performance - Collateral<br>standard: Usability IEC 62304: 2015: Medical<br>device software - Software life<br>cycle processes | Storz Medical MAGNETOLITH<br>Muscle Stimulator<br>compatibility – Requirements<br>and tests. IEC 60601-1-6: 2012 (3.1<br>Ed.): Medical electrical<br>equipment - Part 1-6:<br>General requirements for<br>basic safety and essential<br>performance – Collateral<br>standard: Usability. IEC 62304:2015: Medical<br>Device Software - Software<br>Life Cycle Process. | Bemer Classic & Pro Programmable electrical<br>medical systems. IEC/EN 60601-1-6: 3rd Medical<br>Electrical Equipment, Part 1-6,<br>Usability IEC/EN 60601-1-11: 2010<br>Medical Electrical<br>Equipment, Part 1-11, General<br>requirements for basic safety<br>and essential performance<br>Collateral Standard:<br>Requirements…