BMC Medical Co., Ltd.

During an inspection of 3B Medical, Inc. (d.b.a. React Health, Inc.) located at 5475 Rings Road, Dublin, OH 43017 from December 1, 2025 through December 10, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is the specification developer and 510(k) owner of various ventilator devices that are imported to the United States by 3B Medical, Inc. This includes Auto-Adjusting Positive Airway Pressure (Auto-CPAP or APAP) ventilator devices, intended for the treatment of obstructive sleep apnea in adults, under the brand name of G3X APAP (G4600). Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.

Our inspection revealed that your G3X APAP devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution these devices with significant changes or modifications without submitting a new premarket notification to FDA, as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)]. The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

Your firm has made significant changes or modifications to the design of the Luna® CPAP and Auto CPAP System which was granted clearance on September 8, 2016 under 510(k) number K153387. The inspection at 3B Medical, Inc. established that you are the design change authority and 510(k) owner of the device. For example, FDA has reviewed your firm’s nP3_Product System Verification Report_G3-2.11.01 and Design change evaluation report, Project code: nP3 for the Luna G3 APAP, Model LG3600, approved on March 12, 2025, which revealed that the firmware/software was updated with additional recognition features, i.e., (1) Flow Limitation, (2) Respiratory Effort-Related Arousals (RERA), and (3) Periodic breathing, to distinguish between central hypopnea and obstructive hypopnea events.

Furthermore, the sound abatement system of the cleared Luna APAP devices was modified to ‘(b)(4)’ or ‘(b)(4)’ and a new (b)(4) was added to the cleared Luna APAP device to match the sound reduction as a result of the material change. Additionally, the Printed Circuit Board Assembly (PCBA) includes a new (b)(4) chip compatible with the new algorithm and new data structure master control software. These design modifications to the cleared Luna APAP appear to have given rise to a new model branded as G3X APAP. These changes could significantly affect safety or effectiveness because they are significant changes in the design and materials of these devices. The firmware update introduced new detection algorithms capable of distinguishing between central and obstructive hypopnea events, which affects the accuracy of event classification and the data available to clinicians for evaluating therapy effectiveness and informing future therapy adjustments. The removal of (b)(4) represents a material change to the gas pathway that raises biocompatibility concerns, and when combined with the addition of a new (b)(4), these changes could affect the overall pressure and flow profile of the device, thereby impacting therapy delivery. The addition of a new (b)(4) PCBA chip and updated master control software introduces potential implications for electrical safety and overall device performance. Collectively, these changes represent significant modifications in device design, materials, and software that could significantly affect the safety and effectiveness of the device.

FDA’s regulations at 21 CFR 807.81(a)(3)(i) provide that submission of a 510(k) is required for “a change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process.” Thus, the G3X APAP is misbranded under 502(o) because of your failure to submit the required premarket notification for the modifications. FDA requests that your firm cease any activities that result in the misbranding or adulteration of your devices.

For further explanation on the need for a new premarket notification, or "510(k)," for changes to the intended use or design affecting safety and effectiveness, consult the guidance document "Deciding When to Submit a 510(k) for a Change to an Existing Device — Guidance for Industry and Food and Drug Administration Staff (fda.gov)." The “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Guidance for Industry and Food and Drug Administration Staff,” is also recommended for obtaining FDA feedback on the 510(k) submission for the G3 X APAP devices.

Our inspection also revealed that your firm’s Luna G3 APAP devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 806 – Medical Devices; Reports of Corrections and Removals.

Significant violations include, but are not limited to, the following:

1. Failure to submit a Report required by 21 CFR 806.10 to FDA, within 10 working days of initiating the correction or removal. For example: your Luna G3 APAP devices with firmware G3-2.00.76 could cause the Luna G3 APAP device to unexpectedly shut down during use, which causes loss of therapy for patients with obstructive sleep apnea. You communicated with 3B (React Health) in (b)(4) to (b)(4). The action of updating the firmware to G3-2.00.77 is a medical device correction or removal initiated to reduce a risk to health posed by the device or to remedy a violation of the Act caused by the device which may present a risk to health, for which you are required to submit a Report of Correction or Removal to FDA.

Your firm has not submitted a Report of Correction or Removal to FDA for the firmware update to G3-2.00.77 as of May 19, 2026.

Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts.

On February 2, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world. The revised part 820, referred to as the Quality Management System Regulation (QMSR), became effective on February 2, 2026. The inspection of 3B Medical on December 1, 2025 to December 10, 2025 was conducted pursuant to the QS Regulation, which was in effect at the time of the inspection. However, should any corrective actions you propose or implement relate to device current good manufacturing practice (CGMP) requirements, they must be made pursuant to the QMSR requirements in effect as of February 2, 2026. For more information on the QMSR please refer to our frequently asked questions webpage: https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective action (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent via email to Gina Brackett, Establishment Assessment Team 1 Assistant Director at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case 725759” when replying. If you have any questions about the contents of this letter, please contact: Sargum Morgan, Compliance Officer at sargum.morgan@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.