Velox Power Chair

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 12, 2024 Velox Manufacturing Inc % Sarah Mundim Regulatory Affairs Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road. 2500 Bee Cave Road Austin, Texas 78746 Re: K231315 Trade/Device Name: Velox Power Chair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: January 8, 2024 Received: January 8, 2024 #### Dear Sarah Mundim: 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 (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}------------------------------------------------ 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 (OS) 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 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. 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 medical devices and radiation-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). Sincerely, Tushar Bansal -S for Heather Dean, PhD Assistant Director, Acute Injury Devices Team {2}------------------------------------------------ DHT5B: Division of Neuromodulation and Rehabilitation 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 510(k) Number (if known) K231315 Device Name Velox Power Chair Indications for Use (Describe) The Velox power wheelchair is a battery operated device that is intended to provide mobility to individuals who lack mobility and who have the capability to operate a power wheelchair while being restricted to the seated position. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) X 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 The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary: | Submitter Information | | |-----------------------|-----------------------------------------------| | Company: | Ryan Batke | | | Director | | | Velox Manufacturing Inc Unit | | | 15 26157 Fraser Hwy | | | Langley, British Columbia V4W2W8 Canada | | | Telephone: 604-209-5367 | | | Fax: veloxmanufacturing@gmail.com | | Contact: | Sarah Mundim | | | Regulatory Affairs Consultant Emergo | | | Global Consulting, LLC | | | 2500 Bee Cave Road, 2500 Bee Cave Road Austin | | | Texas, 78746, USA | | | Telephone: 512.222.0250 | | | lst.aus.projectmanagement@ul.com | | Date Summary Updated: | January 11, 2024 | | Device Information | | | Trade Name: | Velox Power Chair | | Common Name: | Powered wheelchair | | Classification Name: | wheelchair, powered (21 CFR 890.3860) | | Review Panel: | Physical Medicine (PM) | | Regulation: | 890.3860 | | Device Class: | II | | Product Code: | ITI | #### Equivalence Claimed to Predicate Device The Velox Power Chair is equivalent to the Quickie, Zippie (K142457), manufactured by Sunrise Medical (US) LLC. #### Device Description The Velox Power Chair is designed for everyday use for both indoor environments including care facilities and private residences. The subject device is intended to provide mobility to persons that are restricted or limited to a sitting position. The Velox Power Chair is a battery powered, electric motor driven device that can be used on both indoor and outdoor surfaces, on soft/rough terrain. The user controls the speed and direction of the wheelchair using the joystick and hand control buttons mounted on the chair. The brakes of the wheelchair are electromagnetic. #### Substantial Equivalence Comparison The following table compares the subject device to the predicate, with additional description provided below. {5}------------------------------------------------ | Characteristic | Proposed Device:<br>Velox Power Chair<br>(K231315) | Predicate Device:<br>Quickie, Zippie (K142457) | Comparison | |------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for<br>Use | The Velox Power<br>Wheelchair is a battery-<br>operated device that is<br>intended to provide mobility<br>to individuals who lack<br>mobility and who have the<br>capability to operate a<br>power wheelchair while<br>being restricted to the<br>seated position. | Quickie® and Zippie® power<br>wheelchairs are battery-<br>operated devices with wheels<br>that are intended for medical<br>purposes to provide mobility<br>to persons restricted to a<br>sitting position. The Zippie®<br>power wheelchairs are<br>specifically for people who<br>are slightly smaller in<br>stature— including children. | Equivalent; the difference is<br>that the predicate device has<br>a different model for people<br>who are slightly smaller in<br>stature, whereas Velox has<br>only one model. | | Intended Use | Provide mobility to persons<br>restricted to a sitting position. | Provide mobility to persons<br>restricted to a sitting position. | Same. | | Device<br>Materials | Steel and aluminum. | Steel and aluminum. | Same. | | Dimensions | 25" x 35" (length by width) | 24"x 34" (length by width) | Equivalent; difference in<br>dimension is small and does<br>not affect the safety or<br>effectiveness. | | Maximum<br>User Weight | 300 lbs | 300 lbs | Same. | | Regulation<br>Description | Powered Wheelchair | Powered Wheelchair | Same. | | Location for<br>Use | Indoors, outdoors,<br>soft/rough terrain. | Indoors, outdoors. | Equivalent; the difference in<br>location for use does not affect<br>the safety or effectiveness. | | Maximum<br>Speed | 5.64 mph | 6 mph | Equivalent; the slight<br>difference in maximum<br>speed does not affect the<br>use of the device. No<br>impact on safety and<br>effectiveness. | | Rolling Base<br>Weight (lbs) | 145 | 130 | Equivalent; difference in<br>weight does not affect the<br>use of the device. No<br>impact on safety and<br>effectiveness. | | Power Source | Batteries | Batteries | Same. | {6}------------------------------------------------ | Range (miles) | 15.38 | Not publicly available | No impact on safety and effectiveness. The difference in range, if any, would come down to the way the drive range is calculated based on various factors. Also, difference in range of miles has many factors, such as weight of | |---------------|-------|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |---------------|-------|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristic | Proposed Device:<br>Velox Power Chair | Predicate Device:<br>Quickie, Zippie (K142457) | Comparison | |-------------------------------------|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Climbing<br>Ability | 1.5" - 2" | Not publicly available | the user, terrain, extra bags<br>being carried etc.<br>No impact on safety and<br>effectiveness. The difference<br>in climbing ability does not<br>affect the use of<br>the device. | | Software /<br>Controls | R-Net or VR2 from Curtiss<br>Wright | VR2 from PGDT | Equivalent: Both use the<br>same controller module<br>(VR2). Velox powerchairs<br>may be equipped with the<br>alternative program R-Net<br>from the same supplier, but<br>both controllers are<br>equivalent in functions and<br>this difference does not<br>affect safety or effectiveness<br>of the device. | | Pivot Radius | 25.50" | Not publicly available | No impact on safety and<br>effectiveness if there is any<br>difference. The difference in<br>pivot radius does not affect<br>the use of the device. | | Battery<br>Details | 8G22NF Gel Cell or 8G24SS<br>Gel Cell, Sealed lead acid or<br>gel batteries | 22 NF, sealed lead acid or gel<br>cell | Same. | | Drive Wheel<br>Diameter<br>(inches) | 13.5 | 13 | Equivalent. The slight<br>difference in inches does not<br>affect safety or effectiveness<br>of the device. | | Lift Range<br>(inches) | 0-15" (from the top of the<br>plastic to the top of the rehab<br>seat) / 0-12" (the lift platform<br>by itself) | 0-12" | Same. | | Tilt Range | 0-50° | 0-50° | Same. | {7}------------------------------------------------ | Suspension | Cloud suspension which<br>reduces vibration with shock<br>absorbers | Standard all wheel<br>suspension with shock<br>absorbers | Equivalent, suspension<br>reduces vibration. | |----------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------|---------------------------------------------------------------------------------| | Folding<br>mechanism | Yes (fold down backrest) | Yes (fold down backrest) | Same. | | Armrest | Height adjustable,<br>removable, flip up option,<br>depth adjustable | Height adjustable and flip up<br>option | Equivalent. Additional<br>options do not affect the<br>safety or effectiveness. | | Footrest | Fixed, flip up, swing away,<br>angle adjustable, rigid<br>footplates or footboard | Swing away footrests with<br>heel loops | Equivalent Additional<br>options do not affect the<br>safety or effectiveness. | | Characteristic | Proposed Device: | Predicate Device: | Comparison | |---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Velox Power Chair | Quickie, Zippie (K142457) | | | Anti-pitch<br>Mechanism<br>for Climbing | Six wheels provide pitch<br>stabilization | Anti-pitch lock-out | Equivalent: Pitch is<br>controlled to ensure<br>appropriate stability. No<br>impact on safety and<br>effectiveness. | | Speed settings | Proportional.<br>The braking settings are set<br>according to the guidance of<br>the therapist involved in<br>setting up the chair with the<br>client. | Not publicly available | No impact on safety and<br>effectiveness if there is any<br>difference. The difference in<br>speed settings does not affect<br>the use of the device. | | Minimum<br>braking<br>distance from<br>maximum<br>speed | Programmable.<br>The minimum braking<br>distance for a wheelchair<br>depends on various factors,<br>including the speed of the<br>chair, road conditions, the<br>reaction time of the braking,<br>and the reaction time of the<br>person operating the chair.<br>Just like the speed settings<br>the braking settings are set<br>according to the guidance of<br>the therapist involved in<br>setting up the chair with the<br>client. | Not publicly available | No impact on safety and<br>effectiveness if there is any<br>difference. The difference in<br>minimum braking distance<br>from maximum speed does<br>not affect the use of the<br>device. | | Recline range | 0-170° | Not publicly available | No impact on safety and<br>effectiveness if there is any<br>difference.<br>The difference in recline range<br>does not affect the use of the<br>device. | {8}------------------------------------------------ ## Summary of Non-Clinical Testing The following tests were performed to demonstrate substantial equivalence based on current industry and FDA recognized standards: - · Static stability (per ISO 7176-1 / RESNA Section 1) - · Dynamic stability (per ISO 7176-2 / RESNA Section 2) - Effectiveness of brakes (per ISO 7176-3 / RESNA Section 3) - · Energy consumption (per ISO 7176-4 / RESNA Section 4) - Dimensions, mass, and maneuvering space (per ISO 7176-5 / RESNA Section 5) - Maximum speed, acceleration, and deceleration (per ISO 7176-6 / RESNA Section 6) - Measurement of seat and wheel dimensions (per ISO 7176-7 / RESNA Section 7) - Static, impact, and fatigue (per ISO 7176-8 / RESNA Section 8) - · Climatic test (per ISO 7176-9 / RESNA Section 9) - Obstacle climbing ability (per ISO 7176-10 / RESNA Section 10) - · Test dummies (per ISO 7176-11 / RESNA Section 11) - Determination of coefficient of friction of test surfaces (per ISO 7176-13 / RESNA Section 13) - Power and control systems for power wheelchairs (per ISO 7176-14 / RESNA Section 14) - Documentation and labeling (per ISO 7176-15 / RESNA Section 15) - · EMC testing (per ISO 7176-21 / RESNA Section 21) - Changing occupant posture (per ISO 7176-30 / RESNA Section 30) ### Substantial Equivalence Comparison Velox Power Chair has some minor differences in technological characteristics to the predicate device, which are detailed and addressed in the Substantial Equivalence Table. The differences are such as in dimensions, weight, battery capacity, suspension and anti-pitch mechanism, whose values are different but similar to the predicate device and do not affect the use of the device and do not impact the safety or effectiveness of the device. Also, Velox Power wheelchair has additional armrest and footrest options to accommodate user preference; these do not affect safety or effectiveness of the device. The results of the above tests indicate that the Velox Power Chair is substantially equivalent to the predicate device. #### Conclusion Velox Power Chair has the same intended use as the predicate device, and the same or similar technological characteristics. The differences in technological characteristics do not raise new or different questions of safety and effectiveness. Performance testing has demonstrated the Velox Power wheelchair is as safe and effective as the predicate device. The Velox Power Chair is substantially equivalent to the predicate device.