Trexo Theo

{0} **U.S. FOOD & DRUG** ADMINISTRATION September 2, 2026 Trexo Robotics, Inc. Linda Wu Director of Regulatory, Quality and Clinical Affairs 6705 Milcreek Dr. Unit 3 Mississauga, ON L5N 5M4 Canada Re: K254198 Trade/Device Name: Trexo Theo Regulation Number: 21 CFR 890.3480 Regulation Name: Powered Lower Extremity Exoskeleton Regulatory Class: Class II Product Code: PHL Dated: July 31, 2026 Received: August 3, 2026 Dear Linda Wu: 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. {1} K254198 - Linda Wu 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 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- {2} K254198 - Linda Wu 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, # Tushar Bansal -S Tushar Bansal, PhD Acting Assistant Director, Acute Injury Devices Team 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 {3} | 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. | K254198 | ? | | Please provide the device trade name(s). | | ? | | Trexo Theo | | | | Please provide your Indications for Use below. | | ? | | The Trexo Theo is a powered exoskeleton intended to perform ambulatory functions in patients 12 years and older with cerebral palsy. The Trexo Theo is intended to be used in a community setting under the supervision of a trained companion who has been certified to the companion training program prior to use of the device. The device is also intended to be used in a clinical setting under the supervision of a trained therapist who has been certified to the therapist training program prior to use of the device. The Trexo Theo is not intended for sports or stair climbing. | | | | 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) | ? | {4} 510k Summary Trexo Robotics # 510(k) Summary # K254198 # 1. Submitter Information | Company Name | Trexo Robotics | | --- | --- | | Company Address | 6705 Millcreek Drive, Unit 3, Mississauga, L5N 5M4 | | Company Phone | 1 844-844-0607 | | Contact Person | Linda Wu (Director of Regulatory, Quality and Clinical) | | Date Prepared | August 28, 2026 | # 2. Device Information | Device Trade Name | Trexo Theo | | --- | --- | | Device Common Name | Powered Exoskeleton | | Device Classification | Powered lower extremity exoskeleton | | Product Code | PHL | | Classification Panel | Neurology/Physical Medicine (OHT5) | | Class | 2 | | Regulation Number | 21 CFR 890.3480 | # 3. Predicate Devices | Name | Manufacturer | 510(k) | | --- | --- | --- | | Medical HAL Lower Limb Type (HAL-ML) | Cyberdyne Inc. | K233695 | | Rewalk P6.0 | Rewalk Robotics Ltd. | K221696 | # 4. Indications for Use Statement The Trexo Theo is a powered exoskeleton intended to perform ambulatory functions in patients 12 years and older with cerebral palsy. The Trexo Theo is intended to be used in a community setting under the supervision of a trained companion who has been certified to the companion training program prior to use of the device. The device is also intended to be used in a clinical setting under the supervision of a trained therapist who has been certified to the therapist training program prior to use of the device. The Trexo Theo is not intended for sports or stair climbing. # 5. Device Description The Trexo Theo (herein referred to as 'Trexo') is a battery-powered, wearable lower-limb exoskeleton intended to assist gait in individuals with impaired walking. The device is worn over the legs and is used with a rigid, four-wheeled, lockable walker frame that provides body-weight support and fall-prevention during use. The device is controlled by a trained operator through a dedicated Trexo tablet connected via the device Wi-Fi network, where they can select gait settings, initiate ambulation, Confidential (Page 1 of 5) {5} 510k Summary Trexo Robotics and adjust speed. Real-time device status and performance metrics are displayed on the tablet, and visual LED indicators on the device legs communicate operating state. The device incorporates multiple safety features including: automatic cessation of actuation if tablet-to-device communications are lost, safe stop upon battery depletion, and a physical Emergency Stop (E-Stop) button on the battery box that removes power to the actuators. In safe-stop states, joints become non-actuated while the walker and chest prompt continues supporting the user. The device is provided in multiple sizes with size-specific hip and knee torque ceilings and configurable assistance levels appropriate for the indicated population. The device includes accessories such as footplates, shin/thigh cuffs, a chest prompt, saddle, contracture blocks, headrest, arm prompts, steering guide rod, and the Trexo Treadmill. ## 6. Comparison to Predicate Devices ### a. Indications for Use The subject device is a powered lower-limb exoskeleton intended to perform ambulatory functions in individuals with cerebral palsy who are 12 years and up, under supervision in both clinic and community environments. The primary predicate, HAL-ML, is a powered exoskeleton indicated for improved ambulation in individuals with neuromuscular conditions including cerebral palsy, in rehabilitation and clinical environments under trained supervision. The Trexo device is indicated for use in a subset of the patient population cleared for HAL-ML and supports similar ambulatory functions, including standing and level-ground walking. The secondary predicate, Rewalk, is a powered exoskeleton indicated to perform ambulatory functions in home and community environments under supervision of trained companions. The Trexo device similarly supports supervised assisted ambulation outside of clinical environments. Across the subject and predicate devices, the indications of use are limited to powered assistance for ambulation. Trexo has submitted clinical data to support the safety and effectiveness of the device used in the different intended settings. ### b. Technological Comparison Trexo and the predicate devices are battery-powered, lower-limb exoskeletons intended to provide assistance for ambulation by generating lower-extremity joint motion through motorized actuation. All devices are used under supervision consistent with their labeled environments of use. Overall configuration and assisted joints: Trexo is a wearable lower-limb exoskeleton worn over the legs. The device provides powered assistance at the hip and knee joints. HAL-ML and Rewalk are similarly wearable lower-limb exoskeletons that provide powered assistance through actuated hip and knee joints. User support and stability method: Trexo is used with a rigid, four-wheeled, lockable walker frame that provides external support during use. HAL-ML is designed for use with a body-weight support system and Rewalk is designed for use with crutches to assist with balance during ambulation. These differences reflect different support configurations while maintaining the same fundamental technological approach of powered assistance to lower-limb actuation. Control and User Interface: Trexo is controlled by a trained operator using a dedicated Trexo tablet connected through the device WI-Fi network to select gait settings, initiate ambulation, and adjust speed. Device operating status is communicated via the tablet interface and device indicators. HAL-ML and Rewalk utilize different control approaches and user interfaces consistent Confidential (Page 2 of 5) {6} 510k Summary Trexo Robotics with their cleared configurations; however, all devices include controls to initiate, adjust, and stop assisted ambulation. Safety-related design features: Trexo incorporates safety features including a communication-loss response (automatic cessation of actuation upon loss of tablet-to-device communications), a safe stop upon battery depletion, and a physical Emergency Stop button that removes power to the actuators. In safe-stop states, joint actuation is disabled while external support is maintained through the walker frame. The predicate device similarly incorporates safety related controls intended to support controlled stopping and system power interruption consistent with their cleared designs. Sizing and configurable assistance: The Trexo is provided in multiple sizes and includes size-specific hip and knee torque limits, configurable assistance levels, and adjustable joint range-of-motion (ROM) settings appropriate for the indicated user population. Predicate devices are also available in configured sizes and/or adjustable settings consistent with their cleared and labeled use. Trexo configurable accessories: The configurable accessories such as footplates, shin/thigh cuffs, a chest prompt, saddle, contracture blocks, headrest, arm prompts, and steering guide rod serve positioning, comfort, and patient-specific fitting functions analogous to the strapping and adjustable elements of the predicate devices. The Trexo device can be loaded onto an optional Trexo treadmill (not available from predicate), for stationary walking. The treadmill is entirely passive, containing no motor, electrical components, or battery connections. Performance testing on the treadmill and other configurable accessories have been conducted to confirm safe and effective performance. To conclude, Trexo conforms to all core performance testing standards used for the predicate device. Bench testing and clinical data demonstrate stable closed-loop behaviour and operating limits. Therefore the technological differences do not raise new questions regarding safety and effectiveness of the device. ### 7. Non-Clinical Performance Testing The following testing was conducted to evaluate that the device meets its specifications: - Electrical safety and essential performance (IEC 60601-1 and applicable collateral/particular standards) including: - Medical robots for Rehabilitation IEC 80601-2-78 - Usability and Human Factors per IEC 60601-1-6, IEC 62366-1/-2 and FDA guidance - Home Healthcare Testing per IEC 60601-1-11 - Battery safety and transport (IEC 62133-2 / UN 38.3) - Ingress protection (IEC 60529) - Electromagnetic compatibility/immunity (EMC/EMI) (IEC 60601-1-2) including: - Performance Evaluation per IEC 60601-4-2 - Common Emitters (5G, RFID, WPT, EAS/Metal Detectors) - Software verification and validation under IEC 62304 - Biocompatibility per ISO 10993-1 and FDA guidance - Packaging validation per ISTA 3A - Wireless coexistence per ANSI C63.27 - Cybersecurity assessment consistent with FDA guidance Confidential (Page 3 of 5) {7} 510k Summary Trexo Robotics • Other Trexo internal performance testing. Most Notably: o Endurance Testing o Torque Accuracy Testing o Performance Testing o Battery Testing o Joint Position Accuracy Testing All planned non-clinical testing were successfully completed and passed against predefined acceptance criteria. These results demonstrate that the Trexo device performs safely and as intended and does not raise new questions of safety or effectiveness compared to the predicate devices. ### 8. Clinical Data Summary Clinical performance data were relied upon to support substantial equivalence and to address the special controls for powered lower-body exoskeletons. # Trexo real-world evidence study The multi-site real world evidence study evaluating Trexo use in the intended population directly assessed functional ambulation performance, device use patterns, and adverse event rates in the indicated population and settings. The device was clinically evaluated to assess safety and functional performance when used by patients aged 12 years and older with cerebral palsy (CP). The evaluation was based on a retrospective analysis of real-world use data collected on the device from 2019 to 2025 from both clinical and home/community settings. All trexo-assisted walking sessions were conducted by trained operators under defined supervision requirements. The device was used in indoor and outdoor environments, including clinical rehabilitation settings, schools, community locations, and homes. Use occurred on common walking surfaces like the Trexo treadmill, common clinic and household flooring (e.g. tile, hardwood, carpet), and outdoor paved surfaces (e.g. concrete and paving stone). A total of 124 users were included in the study - 70 users used the device in their home/community and the remaining used it in clinical rehabilitation centers or rehabilitation schools. More than 77% were GMFCS Levels III - IV and 24% were unable to walk or initiate steps independently at baseline. The primary study efficacy endpoint was total steps taken during Trexo walking sessions, used as an objective measure of stepping activity enabled by the device. Results indicated that total cumulative steps taken by all users were 21,669,731 with a median steps per user per session being 710, with GMFCS III and IV users having the highest median step counts of 1,253 and 1,198, respectively. This highlights the device's capacity to support consistent gait practice even among individuals with substantial functional limitations. The primary study safety endpoint was incidence of AEs. There were no (0%) reported device-related serious adverse events in the study. When normalized to exposure, the AE rate was remarkably low, at 0.002 per 1,000 steps overall. 19.4% of users reported that they did experience some adverse event during their device usage period (median usage duration was 126 weeks and 20 weeks for home/community and clinic/rehabilitation school users, respectively), but all were expected of exoskeleton use, including pain, discomfort, redness, bruising, skin abrasions/lesions, blisters, and minor static shock. Notably all reported events were classified as having either negligible or minimal severity of harm. There were no reported AEs related to sprains/strains, fracture, joint dislocation, head/neck injury, or cardiovascular issues. There were no unexpected adverse events reported. Confidential (Page 4 of 5) {8} 510k Summary Trexo Robotics # Published literature Numerous articles were identified reporting outcomes in patients with cerebral palsy using the Trexo device, including a study with validated 6MWT endpoints. The sample size range of the studies are n=1 to n=171. Studies were conducted in both supervised clinical rehabilitation settings and in supervised home settings consistent with the indications for use. No serious or unexpected device-related adverse events were reported. Published literature consistently demonstrated successful Trexo-assisted stepping and improvements or favourable trends in functional ambulation measures. Reported outcomes show that Trexo use enables repeatable overground stepping volumes per session and sustained stepping over longitudinal home/community use, with associated improvements in functional mobility. # 9. Conclusions Subject and predicate devices share the same intended use and fundamental scientific technology, including principles of operation and mechanism of action. Differences in design and technological characteristics between the subject and predicate devices do not raise any new types of questions of safety and effectiveness. The results of performance testing support substantial equivalence of the subject device with its predicate devices. Confidential (Page 5 of 5)