(252 days)
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.
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.
The provided text describes the 510(k) summary for the Velox Power Chair, a powered wheelchair. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing specific acceptance criteria and a detailed study report for a novel AI/software medical device.
Therefore, many of the requested elements for an AI/software device performance study are not applicable to this document. The information provided is characteristic of a traditional medical device submission where equivalence is shown through comparison and adherence to recognized performance standards.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in the format typically used for software performance metrics (e.g., sensitivity, specificity thresholds). Instead, it establishes "substantial equivalence" based on comparing characteristics to a predicate device and demonstrating compliance with recognized performance standards.
The table below summarizes the comparison to the predicate device, which implicitly defines the performance "acceptance" by showing that the Velox Power Chair's characteristics are either "Same" or "Equivalent" and do not raise new questions of safety or effectiveness.
| Characteristic | Proposed Device: Velox Power Chair (K231315) | Predicate Device: Quickie, Zippie (K142457) | Comparison (Implicit Acceptance) | Reported Performance (Velox Power Chair) |
|---|---|---|---|---|
| Indication for Use | 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. | To provide mobility to persons restricted to a sitting position. The Zippie® power wheelchairs are specifically for people who are slightly smaller in stature—including children. | Equivalent; the difference is that the predicate device has a different model for people who are slightly smaller in stature, whereas Velox has only one model. | 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. |
| Intended Use | Provide mobility to persons restricted to a sitting position. | Provide mobility to persons restricted to a sitting position. | Same. | Provide mobility to persons restricted to a sitting position. |
| Device Materials | Steel and aluminum. | Steel and aluminum. | Same. | Steel and aluminum. |
| Dimensions | 25" x 35" (length by width) | 24"x 34" (length by width) | Equivalent; difference in dimension is small and does not affect the safety or effectiveness. | 25" x 35" (length by width) |
| Maximum User Weight | 300 lbs | 300 lbs | Same. | 300 lbs |
| Regulation Description | Powered Wheelchair | Powered Wheelchair | Same. | Powered Wheelchair |
| Location for Use | Indoors, outdoors, soft/rough terrain. | Indoors, outdoors. | Equivalent; the difference in location for use does not affect the safety or effectiveness. | Indoors, outdoors, soft/rough terrain. |
| Maximum Speed | 5.64 mph | 6 mph | Equivalent; the slight difference in maximum speed does not affect the use of the device. No impact on safety and effectiveness. | 5.64 mph |
| Rolling Base Weight (lbs) | 145 | 130 | Equivalent; difference in weight does not affect the use of the device. No impact on safety and effectiveness. | 145 |
| Power Source | Batteries | Batteries | Same. | Batteries |
| 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 the user, terrain, extra bags being carried etc. | 15.38 |
| Climbing Ability | 1.5" - 2" | Not publicly available | No impact on safety and effectiveness. The difference in climbing ability does not affect the use of the device. | 1.5" - 2" |
| Software / Controls | R-Net or VR2 from Curtiss Wright | VR2 from PGDT | Equivalent: Both use the same controller module (VR2). Velox powerchairs may be equipped with the alternative program R-Net from the same supplier, but both controllers are equivalent in functions and this difference does not affect safety or effectiveness of the device. | R-Net or VR2 from Curtiss Wright |
| Pivot Radius | 25.50" | Not publicly available | No impact on safety and effectiveness if there is any difference. The difference in pivot radius does not affect the use of the device. | 25.50" |
| Battery Details | 8G22NF Gel Cell or 8G24SS Gel Cell, Sealed lead acid or gel batteries | 22 NF, sealed lead acid or gel cell | Same. | 8G22NF Gel Cell or 8G24SS Gel Cell, Sealed lead acid or gel batteries |
| Drive Wheel Diameter (inches) | 13.5 | 13 | Equivalent. The slight difference in inches does not affect safety or effectiveness of the device. | 13.5 |
| Lift Range (inches) | 0-15" (from the top of the plastic to the top of the rehab seat) / 0-12" (the lift platform by itself) | 0-12" | Same. | 0-15" (from the top of the plastic to the top of the rehab seat) / 0-12" (the lift platform by itself) |
| Tilt Range | 0-50° | 0-50° | Same. | 0-50° |
| Suspension | Cloud suspension which reduces vibration with shock absorbers | Standard all wheel suspension with shock absorbers | Equivalent, suspension reduces vibration. | Cloud suspension which reduces vibration with shock absorbers |
| Folding mechanism | Yes (fold down backrest) | Yes (fold down backrest) | Same. | Yes (fold down backrest) |
| Armrest | Height adjustable, removable, flip up option, depth adjustable | Height adjustable and flip up option | Equivalent. Additional options do not affect the safety or effectiveness. | Height adjustable, removable, flip up option, depth adjustable |
| Footrest | Fixed, flip up, swing away, angle adjustable, rigid footplates or footboard | Swing away footrests with heel loops | Equivalent Additional options do not affect the safety or effectiveness. | Fixed, flip up, swing away, angle adjustable, rigid footplates or footboard |
| Anti-pitch Mechanism for Climbing | Six wheels provide pitch stabilization | Anti-pitch lock-out | Equivalent: Pitch is controlled to ensure appropriate stability. No impact on safety and effectiveness. | Six wheels provide pitch stabilization |
| Speed settings | Proportional. The braking settings are set according to the guidance of the therapist involved in setting up the chair with the client. | Not publicly available | No impact on safety and effectiveness if there is any difference. The difference in speed settings does not affect the use of the device. | Proportional. The braking settings are set according to the guidance of the therapist involved in setting up the chair with the client. |
| Minimum braking distance from maximum speed | Programmable. The minimum braking distance for a wheelchair depends on various factors, including the speed of the chair, road conditions, the reaction time of the braking, and the reaction time of the person operating the chair. Just like the speed settings the braking settings are set according to the guidance of the therapist involved in setting up the chair with the client. | Not publicly available | No impact on safety and effectiveness if there is any difference. The difference in minimum braking distance from maximum speed does not affect the use of the device. | Programmable. The minimum braking distance for a wheelchair depends on various factors, including the speed of the chair, road conditions, the reaction time of the braking, and the reaction time of the person operating the chair. Just like the speed settings the braking settings are set according to the guidance of the therapist involved in setting up the chair with the client. |
| Recline range | 0-170° | Not publicly available | No impact on safety and effectiveness if there is any difference. The difference in recline range does not affect the use of the device. | 0-170° |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This document does not refer to a "test set" in the context of an AI/software performance study involving patient data. The testing described is non-clinical performance testing of a physical device. There is no mention of data provenance, country of origin, or whether it was retrospective or prospective data, as these are not relevant to the type of testing conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. Ground truth, in the context of expert review for medical image analysis or similar AI applications, is not relevant here. The "ground truth" for a physical device like a wheelchair is established through engineering specifications and objective measurements against recognized standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no "test set" requiring adjudication by experts in this context.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a physical device, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The Velox Power Chair is a physical device, controlled by a human operator using a joystick. There is no standalone algorithm performance as described for AI devices. The intrinsic performance characteristics (speed, stability, etc.) are measured directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance of the Velox Power Chair is based on objective measurements and compliance with international consensus standards for powered wheelchairs. The document explicitly lists adherence to ISO 7176 series and RESNA sections for various performance metrics. This includes:
- Static stability
- Dynamic stability
- Effectiveness of brakes
- Energy consumption
- Dimensions, mass, and maneuvering space
- Maximum speed, acceleration, and deceleration
- Measurement of seat and wheel dimensions
- Static, impact, and fatigue
- Climatic test
- Obstacle climbing ability
- Test dummies
- Determination of coefficient of friction of test surfaces
- Power and control systems for power wheelchairs
- Documentation and labeling
- EMC testing
- Changing occupant posture
These standards define the benchmarks against which the device's performance is objectively measured.
8. The sample size for the training set:
Not applicable. This is a physical device, not an AI/ML model that requires a training set of data.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply here.
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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.
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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
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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
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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)
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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.
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| Characteristic | Proposed Device:Velox Power Chair(K231315) | Predicate Device:Quickie, Zippie (K142457) | Comparison |
|---|---|---|---|
| Indication forUse | The Velox PowerWheelchair is a battery-operated device that isintended to provide mobilityto individuals who lackmobility and who have thecapability to operate apower wheelchair whilebeing restricted to theseated position. | Quickie® and Zippie® powerwheelchairs are battery-operated devices with wheelsthat are intended for medicalpurposes to provide mobilityto persons restricted to asitting position. The Zippie®power wheelchairs arespecifically for people whoare slightly smaller instature— including children. | Equivalent; the difference isthat the predicate device hasa different model for peoplewho are slightly smaller instature, whereas Velox hasonly one model. |
| Intended Use | Provide mobility to personsrestricted to a sitting position. | Provide mobility to personsrestricted to a sitting position. | Same. |
| DeviceMaterials | Steel and aluminum. | Steel and aluminum. | Same. |
| Dimensions | 25" x 35" (length by width) | 24"x 34" (length by width) | Equivalent; difference indimension is small and doesnot affect the safety oreffectiveness. |
| MaximumUser Weight | 300 lbs | 300 lbs | Same. |
| RegulationDescription | Powered Wheelchair | Powered Wheelchair | Same. |
| Location forUse | Indoors, outdoors,soft/rough terrain. | Indoors, outdoors. | Equivalent; the difference inlocation for use does not affectthe safety or effectiveness. |
| MaximumSpeed | 5.64 mph | 6 mph | Equivalent; the slightdifference in maximumspeed does not affect theuse of the device. Noimpact on safety andeffectiveness. |
| Rolling BaseWeight (lbs) | 145 | 130 | Equivalent; difference inweight does not affect theuse of the device. Noimpact on safety andeffectiveness. |
| Power Source | Batteries | Batteries | Same. |
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| 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:Velox Power Chair | Predicate Device:Quickie, Zippie (K142457) | Comparison |
|---|---|---|---|
| ClimbingAbility | 1.5" - 2" | Not publicly available | the user, terrain, extra bagsbeing carried etc.No impact on safety andeffectiveness. The differencein climbing ability does notaffect the use ofthe device. |
| Software /Controls | R-Net or VR2 from CurtissWright | VR2 from PGDT | Equivalent: Both use thesame controller module(VR2). Velox powerchairsmay be equipped with thealternative program R-Netfrom the same supplier, butboth controllers areequivalent in functions andthis difference does notaffect safety or effectivenessof the device. |
| Pivot Radius | 25.50" | Not publicly available | No impact on safety andeffectiveness if there is anydifference. The difference inpivot radius does not affectthe use of the device. |
| BatteryDetails | 8G22NF Gel Cell or 8G24SSGel Cell, Sealed lead acid orgel batteries | 22 NF, sealed lead acid or gelcell | Same. |
| Drive WheelDiameter(inches) | 13.5 | 13 | Equivalent. The slightdifference in inches does notaffect safety or effectivenessof the device. |
| Lift Range(inches) | 0-15" (from the top of theplastic to the top of the rehabseat) / 0-12" (the lift platformby itself) | 0-12" | Same. |
| Tilt Range | 0-50° | 0-50° | Same. |
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| Suspension | Cloud suspension whichreduces vibration with shockabsorbers | Standard all wheelsuspension with shockabsorbers | Equivalent, suspensionreduces vibration. |
|---|---|---|---|
| Foldingmechanism | Yes (fold down backrest) | Yes (fold down backrest) | Same. |
| Armrest | Height adjustable,removable, flip up option,depth adjustable | Height adjustable and flip upoption | Equivalent. Additionaloptions do not affect thesafety or effectiveness. |
| Footrest | Fixed, flip up, swing away,angle adjustable, rigidfootplates or footboard | Swing away footrests withheel loops | Equivalent Additionaloptions do not affect thesafety or effectiveness. |
| Characteristic | Proposed Device: | Predicate Device: | Comparison |
|---|---|---|---|
| Velox Power Chair | Quickie, Zippie (K142457) | ||
| Anti-pitchMechanismfor Climbing | Six wheels provide pitchstabilization | Anti-pitch lock-out | Equivalent: Pitch iscontrolled to ensureappropriate stability. Noimpact on safety andeffectiveness. |
| Speed settings | Proportional.The braking settings are setaccording to the guidance ofthe therapist involved insetting up the chair with theclient. | Not publicly available | No impact on safety andeffectiveness if there is anydifference. The difference inspeed settings does not affectthe use of the device. |
| Minimumbrakingdistance frommaximumspeed | Programmable.The minimum brakingdistance for a wheelchairdepends on various factors,including the speed of thechair, road conditions, thereaction time of the braking,and the reaction time of theperson operating the chair.Just like the speed settingsthe braking settings are setaccording to the guidance ofthe therapist involved insetting up the chair with theclient. | Not publicly available | No impact on safety andeffectiveness if there is anydifference. The difference inminimum braking distancefrom maximum speed doesnot affect the use of thedevice. |
| Recline range | 0-170° | Not publicly available | No impact on safety andeffectiveness if there is anydifference.The difference in recline rangedoes not affect the use of thedevice. |
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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.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).