(252 days)
Not Found
No
The description focuses on the mechanical and electrical aspects of a standard power wheelchair controlled by a joystick, with no mention of AI or ML capabilities.
No.
The Velox power wheelchair is intended to provide mobility to individuals who lack mobility, but it is not designed to treat, cure, or prevent any medical condition or disease, which would qualify it as a therapeutic device.
No.
The device is a power wheelchair intended to provide mobility, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states it is a "battery powered, electric motor driven device" with a joystick, hand control buttons, and electromagnetic brakes, indicating it is a physical hardware device.
Based on the provided information, the Velox power wheelchair is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Velox Power Wheelchair Function: The Velox power wheelchair is a mobility device designed to help individuals with limited mobility move around. It does not involve the examination of any biological specimens.
- Intended Use: The intended use clearly states it's for providing mobility to individuals who lack it.
- Device Description: The description focuses on its mechanical and electrical components for movement.
- Lack of Relevant Information: The document does not mention any aspects related to biological samples, laboratory testing, or diagnostic purposes.
Therefore, the Velox power wheelchair falls under the category of a medical device, but specifically a mobility aid, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
ITI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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)
The results of the above tests indicate that the Velox Power Chair is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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.
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)
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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:
Velox Power Chair
(K231315) | Predicate Device:
Quickie, Zippie (K142457) | Comparison |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
Use | 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. | Quickie® and Zippie® power
wheelchairs are battery-
operated devices with wheels
that are intended for medical
purposes 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. |
| Intended Use | Provide mobility to persons
restricted to a sitting position. | Provide mobility to persons
restricted to a sitting position. | Same. |
| Device
Materials | Steel and aluminum. | Steel and aluminum. | Same. |
| 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. |
| Maximum
User Weight | 300 lbs | 300 lbs | Same. |
| Regulation
Description | Powered Wheelchair | Powered Wheelchair | Same. |
| Location for
Use | Indoors, outdoors,
soft/rough terrain. | Indoors, outdoors. | Equivalent; the difference in
location for use does not affect
the safety or effectiveness. |
| 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. |
| Rolling Base
Weight (lbs) | 145 | 130 | Equivalent; difference in
weight does not affect the
use of the device. No
impact on safety and
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:
Velox Power Chair | Predicate Device:
Quickie, Zippie (K142457) | Comparison |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Climbing
Ability | 1.5" - 2" | Not publicly available | the user, terrain, extra bags
being carried etc.
No impact on safety and
effectiveness. The difference
in climbing ability does not
affect the use of
the device. |
| 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. |
| 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. |
| Battery
Details | 8G22NF Gel Cell or 8G24SS
Gel Cell, Sealed lead acid or
gel batteries | 22 NF, sealed lead acid or gel
cell | Same. |
| Drive Wheel
Diameter
(inches) | 13.5 | 13 | Equivalent. The slight
difference in inches does not
affect safety or effectiveness
of the device. |
| 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. |
| Tilt Range | 0-50° | 0-50° | Same. |
7
| Suspension | Cloud suspension which
reduces vibration with shock
absorbers | Standard all wheel
suspension with shock
absorbers | Equivalent, suspension
reduces vibration. |
|----------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------|---------------------------------------------------------------------------------|
| Folding
mechanism | Yes (fold down backrest) | Yes (fold down backrest) | Same. |
| 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. |
| 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. |
| Characteristic | Proposed Device: | Predicate Device: | Comparison |
|---|---|---|---|
| Velox Power Chair | Quickie, Zippie (K142457) | ||
| 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. | |||
| 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. | |||
| 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. | |||
| 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. |
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.