(161 days)
The Sunrise Medical Quickie® Q700-UP M power wheelchairs are battery operated devices, that are indicated for medical purposes to provide mobility and repositioning of the user, including a stand-up feature.
This submission covers the Q700-UP M which includes the following new components to the Sunrise Medical Quickie® Pulse 6SC:
-
- Requires a knee block that was a previous option
-
- Adds a stand-up actuator (PG Drives Technology) to power the stand-up feature
-
- Requires a different version of the power center leg-rest to support the patient's weight when standing.
-
- Adds a CSXM power seating control module (PG Drives Technology) to control the seating during standing
-
- A caster / suspension lock-out system to stabilize the base when stand-up is actuated.
The Sunrise Medical Quickie® Q700-UP M power wheelchairs are battery operated devices, that are indicated for medical purposes to provide mobility and repositioning of the user, including a stand-up feature.
The Sunrise Medical Quickie® Q700-UP M power wheelchairs provide seating and standing function for patients who cannot stand on their own.
The document does not describe a study involving a medical device with "acceptance criteria" and "reported device performance" in the typical sense of diagnostic test performance (e.g., sensitivity, specificity, accuracy).
Instead, the document is a 510(k) summary for a medical device called the Quickie® Q700-UP M (a stand-up wheelchair). The "acceptance criteria" and "reported device performance" are presented as compliance with various recognized industry standards and a comparison of technical features to predicate devices to demonstrate substantial equivalence.
Here's the information extracted and formatted according to your request, with clarifications where the terms need to be adapted to the context of a wheelchair 510(k) submission:
1. A table of acceptance criteria and the reported device performance
In the context of this 510(k) submission for a stand-up wheelchair, "acceptance criteria" refers to compliance with recognized consensus standards (primarily ISO 7176 series and RESNA WC-1) and demonstrating substantial equivalence to predicate devices based on technical features. The "reported device performance" is the outcome of testing against these standards and the listed technical specifications.
| Acceptance Criteria (Standard / Feature) | Reported Device Performance (Outcome / Specification) |
|---|---|
| ISO 7176-1 [ANSI/RESNA WC-1/1]: Determination of Static Stability | Pass |
| ISO 7176-2 [ANSI/RESNA WC-2/2]: Determination of Dynamic Stability of Electrically Powered Wheelchairs | Pass |
| ISO 7176-3 [ANSI/RESNA WC-2/3]: Determination of effectiveness of brakes | Pass |
| ISO 7176-4 [ANSI/RESNA WC-2/4]: Energy consumption for determination of theoretical distance | Pass |
| ISO 7176-5 [ANSI/RESNA WC-1/5]: Determination of dimensions, mass and maneuvering space | Pass |
| ISO 7176-6 [ANSI/RESNA WC-2/6]: Determination of maximum speed, acceleration and deceleration | Pass |
| ISO 7176-7 [ANSI/RESNA WC-1/7]: Method of measurement of seating and wheel dimensions | Pass |
| ISO 7176-8 [ANSI/RESNA WC-1/8]: Requirements and test methods for static, impact and fatigue strengths | Pass |
| ISO 7176-9 [ANSI/RESNA WC-2/9]: Climatic tests for electrically powered wheelchairs | Pass |
| ISO 7176-10 [ANSI/RESNA WC-2/10]: Determination of obstacle-climbing ability | Pass |
| ISO 7176-14 [ANSI/RESNA WC-2/14]: Power and control systems - Requirements and test methods | Pass |
| ISO 7176-15 [ANSI/RESNA WC-1/15]: Requirements for information disclosure, documentation and labeling | Pass |
| ISO 7176-16 [ANSI/RESNA WC-1/16]: Resistance to ignition of upholstered parts | Pass |
| ISO 7176-19 [ANSI/RESNA WC-4/19]: Wheeled mobility devices for use as seats in motor vehicles | Pass |
| ISO 7176-21 [ANSI/RESNA WC-2/21]: Electromagnetic compatibility | Pass |
| ISO 10993-5: Biological evaluation of medical devices | Pass (for materials common to many wheelchairs) |
| ISO 7176-25: Batteries and chargers for powered wheelchairs | Pass |
| RESNA WC-1:2009 Section 20: Determination of the Performance of Stand-up Type Wheelchairs | Pass |
| Technical Feature Comparison to Predicate Devices: | |
| Product Code (LeVo C3) | IPL 890.3900 (Identical) |
| Device Description (LeVo C3) | Center-wheel-drive, battery-powered, motor-driven, controlled by PG Drives Technology; functions indoors/outdoors (Equivalent) |
| Picture (in standing mode, LeVo C3) | Wheelchair in standing mode (Equivalent) |
| Seat width (LeVo C3) | 16-22" (Equivalent to predicate's 12.6-20.5 inches) |
| Total width (LeVo C3) | 25" (Equivalent to predicate's 24.8 inches) |
| Total length (LeVo C3) | 36" (Functionally Equivalent to predicate's 41.3 inches) |
| Seat plate depth (LeVo C3) | 16-22" (Functionally Equivalent to predicate's 13.8–24.8 inches) |
| Armrest height (LeVo C3) | 6.3"-12" (Functionally Equivalent to predicate's 5.9-14.1 inches) |
| Turning circle (LeVo C3) | 43 inches (Identical) |
| Speed (LeVo C3) | 6 or 8 mph options (Functionally Equivalent to predicate's 3.7/5/6.2 mph options) |
| Range (LeVo C3) | 21 miles (Functionally Equivalent to predicate's 15.5 miles) |
| Manageable gradient (LeVo C3) | 10° (18%) (Functionally Equivalent to predicate's 15° (33%) actually 28%) |
| Max. curb height (LeVo C3) | 4 inches (Identical) |
| Max. chair weight (LeVo C3) | 375 lbs. (Equivalent to predicate's 407 lbs.) |
| Max. user weight (LeVo C3) | 265 lbs. (Reduced weight capacity compared to predicate's 310 lbs.) |
| Transport volume max. (LeVo C3) | 41"x 25"x 29" (Functionally Equivalent to predicate's 37.8 x 24.8 x 27.1 inches) |
| Controller(s) (Reference device: Quickie Pulse 6SC) | PGDT R-Net Controller Std. (Equivalent) |
| Joystick Mounting (Reference device: Quickie Pulse 6SC) | Standard, Swing-away, Retractable (Equivalent) |
| Attendant Controls (Reference device: Quickie Pulse 6SC) | Optional, for R-Net (Equivalent) |
| Batteries (Reference device: Quickie Pulse 6SC) | Group 24 – 73Ahr; Group 34 -50 Ahr (Equivalent) |
| Power stand-up feature (Reference device: Quickie Pulse 6SC) | Chest support and knee support standard (Identical) |
| Light kit option (Reference device: Quickie Pulse 6SC) | Front & Rear with Turn Signal (Identical) |
| User Weight (Max) (Reference device: Quickie Pulse 6SC) | 265 lb. (Equivalent, limited by standup feature) |
| Structural Materials (Reference device: Quickie Pulse 6SC) | Steel and aluminum frame structure, welded and powder coated, standard foams/covers (Identical) |
| Biocompatibility (Reference device: Quickie Pulse 6SC) | Uses materials common to many Wheelchairs (Identical) |
| Maximum speed (Reference device: Quickie Pulse 6SC) | 6.0 mph, with 8.0 mph option (Equivalent) |
| Overall dimensions (Reference device: Quickie Pulse 6SC) | 25" x 36" (Equivalent) |
| Maximum total weight of base (Reference device: Quickie Pulse 6SC) | 152 lbs. (Equivalent) |
| Batteries (Reference device: Quickie Pulse 6SC) | 24V (2x12V) / 73 Ah/20h; 24V (2x12V) / 60 Ah/20h, Maintenance free (Equivalent) |
| Drive wheels (Reference device: Quickie Pulse 6SC) | 14" diameter (Equivalent) |
| Caster wheels (Reference device: Quickie Pulse 6SC) | 6" Front & Rear (Equivalent) |
| Motors/gearbox (Reference device: Quickie Pulse 6SC) | 6.0 Motor Package (1026W @120A), 8.0 mph Motor Package (1293W @120A) (Equivalent) |
| Anti-pitch mechanism for climbing (Reference device: Quickie Pulse 6SC) | Additional anti-pitch lock-out (Identical) |
| Cosmetic (Reference device: Quickie Pulse 6SC) | Steel tubular box frame, cast aluminum front and rear caster arms, shrouded with ABS plastic covers (Equivalent) |
| Seat options (Reference device: Quickie Pulse 6SC) | SEDEO UP Recline (required by stand-up feature) (Equivalent) |
| Minimum seat height (Reference device: Quickie Pulse 6SC) | 16.2" (Identical) |
| Lift, tilt, recline range (Reference device: Quickie Pulse 6SC) | Lift 0-12", Tilt 0-50°, Recline 0-172° (Identical) |
| Lift, tilt, recline capacity (Reference device: Quickie Pulse 6SC) | Lift 265 lbs., Tilt 265 lbs., Recline 265 lbs. (Equivalent, limited by stand-up feature) |
| Seat dimensions (Reference device: Quickie Pulse 6SC) | Width 16-22", Depth 16-22" (Equivalent) |
| Controller type (Reference device: Quickie Pulse 6SC) | R-Net from PGDT (Equivalent, limited by stand-up feature) |
| Supply voltage (Reference device: Quickie Pulse 6SC) | 24 V dc (Identical) |
| Operating voltage (Reference device: Quickie Pulse 6SC) | 35 V dc (Identical) |
| Reverse battery voltage (Reference device: Quickie Pulse 6SC) | -40 V dc (Identical) |
| PWM frequency (Reference device: Quickie Pulse 6SC) | 19.5 kHz ± 1% (Identical) |
| Brake voltage / current (Reference device: Quickie Pulse 6SC) | Harness with in-line connector; Min 100 mA, Max 1 A (Identical) |
| Charging current (Reference device: Quickie Pulse 6SC) | 12 A rms max (Identical) |
| Charger connection (Reference device: Quickie Pulse 6SC) | Only Neutrik NC3MX (Identical) |
| Actuator current (Reference device: Quickie Pulse 6SC) | Maximum 10 A (Identical) |
| Maximum drive current (Reference device: Quickie Pulse 6SC) | RNet 120A Controller (Equivalent with additional max current output) |
| Moisture resistance (Reference device: Quickie Pulse 6SC) | Compliant with ANSI RESNA WC-9 (Identical) |
| Operating temperature (Reference device: Quickie Pulse 6SC) | -25°C to 50°C (Identical) |
| Storage temperature (Reference device: Quickie Pulse 6SC) | -40°C to 70°C (Identical) |
| Joystick Mount (Reference device: Quickie Pulse 6SC) | Fixed mount, Height adjustable, Swing-away (Identical) |
| Controller Connector (Reference device: Quickie Pulse 6SC) | Harness with in-line connector (Identical) |
| Number of drive profiles (Reference device: Quickie Pulse 6SC) | 5 (Identical) |
| User input (Reference device: Quickie Pulse 6SC) | Joystick and hand control buttons (Identical) |
| On/off button, Speed up/down, Horn button (Reference device: Quickie Pulse 6SC) | Yes (Identical) |
| Actuator control (Reference device: Quickie Pulse 6SC) | Versions available with and without actuator control buttons (Identical) |
| Number of actuators for lift, tilt, recline (Reference device: Quickie Pulse 6SC) | 6 (tilt, stand-up, recline (2), power legrests (2), lift) (Equivalent) |
| Battery state indicator (Reference device: Quickie Pulse 6SC) | LEDs (Identical) |
| Electronics package (Reference device: Quickie Pulse 6SC) | Electronics in both hand control module and motor control module (Identical) |
| Programming tool (Reference device: Quickie Pulse 6SC) | Hand held programmer (Identical) |
| External drive inhibit input (Reference device: Quickie Pulse 6SC) | Yes (Identical) |
| Attendant control (Reference device: Quickie Pulse 6SC) | Option with R-Net system (Identical) |
| Bluetooth PC mouse replacement (Reference device: Quickie Pulse 6SC) | Option with R-Net system (Identical) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify a "sample size" in terms of many individual devices tested for each standard. Instead, it states that "All verification and validation testing conducted demonstrate that the Quickie® Q700-UP M is substantially equivalent..." This implies that at least one device (or a representative number of units) was tested to each listed standard. Standard compliance testing typically involves a small number of units (e.g., 1-3 units) unless otherwise specified by the standard or regulatory body.
- Data Provenance: The document does not explicitly state the country of origin of the test data or whether it was retrospective or prospective. However, given that Sunrise Medical (US) LLC is listed with a Fresno, California address, and the submission is to the U.S. FDA, it is implied that the testing was conducted to meet U.S. regulatory requirements. It is a premarket notification (510(k)), so the testing would have been conducted as part of the development and validation process before market entry, making it prospective testing in anticipation of regulatory submission.
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)
This section is Not Applicable to this submission. The "ground truth" for a medical device like a wheelchair is not established by expert consensus in the same way as an AI diagnostic tool. Instead, the "ground truth" or acceptable performance is defined by adherence to internationally recognized performance standards for wheelchairs (ISO, RESNA). The experts involved would be engineers and technical specialists performing the tests and verifying compliance with these standards, not clinicians establishing a "diagnosis."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in reading medical images for AI ground truth). For physical device testing against standards, the results are typically objectively measured and either pass or fail the specified criteria.
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
This section is Not Applicable. This is a physical medical device (wheelchair), not an AI diagnostic tool involving human "readers" or AI assistance. No MRMC study would be relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by compliance with recognized international and national consensus standards (listed in Table 4) for wheelchair safety, performance, and functionality. These standards define the acceptable range of physical, mechanical, and electrical performance characteristics. The comparison to predicate devices also serves as a benchmark for demonstrating substantial equivalence based on established features of legally marketed devices.
8. The sample size for the training set
This section is Not Applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This section is Not Applicable. As it's not an AI model, there is no "training set" or corresponding ground truth to establish.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 16, 2018
Sunrise Medical (US) LLC Nancy Gertlar Senior Director, Regulatory Affairs and Quality Assurance 2842 Business Park Ave Fresno. California 93727
Re: K172384
Trade/Device Name: Quickie® Q700-UP M Regulation Number: 21 CFR 890.3900 Regulation Name: Standup Wheelchair Regulatory Class: Class II Product Code: IPL Dated: December 8, 2017 Received: December 14, 2017
Dear Nancy Gertlar:
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 (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. 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.
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
{1}------------------------------------------------
801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Vivek J. Pinto -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K172384
Device Name Quickie(R) Q700-UP M
Indications for Use (Describe)
The Sunrise Medical Quickie® Q700-UP M power wheelchairs are battery operated devices, that are indicated for medical purposes to provide mobility and repositioning of the user, including a stand-up feature.
| 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."
{3}------------------------------------------------
510(k) SUMMARY
| Submitted By: | Nancy J GertlarSunrise Medical (US) LLC2842 Business Park AveFresno, CA 93727Phone: 559-294-2395Fax: 559-348-2505 |
|---|---|
| Contact: | Nancy J GertlarSenior Director Regulatory Affairs and Quality AssuranceNancy.gertlar@sunrise.com |
| Date Summary Prepared: | December 1, 2017 |
| Trade Name: | Quickie® Q700-UP M |
| : Common/Classification Name: | Wheelchair, StandupStandup wheelchair |
| Product Code | IPL21 CFR 380.3900 |
| Primary Predicate Device: | Levo C3 Power WheelchairK083017Product Code IPL21 CFR 890.3900 |
| Reference Device: | Sunrise Medical Quickie® Pulse 6SCK142457Product Code ITI |
Description of the Q700-UP M:
This submission covers the Q700-UP M which includes the following new components to the Sunrise Medical Quickie® Pulse 6SC: (illustration follows)
-
- Requires a knee block that was a previous option
-
- Adds a stand-up actuator (PG Drives Technology) to power the stand-up feature
-
- Requires a different version of the power center leg-rest to support the patient's weight when standing.
{4}------------------------------------------------
-
- Adds a CSXM power seating control module (PG Drives Technology) to control the seating during standing
-
- A caster / suspension lock-out system to stabilize the base when stand-up is actuated.
Image /page/4/Figure/2 description: The image shows the Q700-UP M, which is a wheelchair with new components. The image highlights the caster/suspension lock-out system, which stabilizes the base when the stand-up system is actuated. Other components shown are the knee block, CXSM power seating control module, stand-up actuator module, and a different version of the power center mount legrest designed to support the weight of the user.
The Sunrise Medical Quickie® Q700-UP M power wheelchairs are battery operated devices, that are indicated for medical purposes to provide mobility and repositioning of the user, including a stand-up feature.
Q700-UP M
The Sunrise Medical Quickie® Q700-UP M power wheelchairs provide seating and standing function for patients who cannot stand on their own. This chair is intended for patients with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, and other diseases and conditions which limit a patient's mobility.
Indications for Use
The indications for use of the Quickie® Q700-UP M are listed in the table (Table 1) below and compared to the primary predicate device, the Levo C3. The table also demonstrates that the indications for use of the Quickie® Q700-UP M are substantially equivalent to the Levo C3.
| Quickie® Q700-UP M | Levo C3 (Primary Predicate) | Comparison |
|---|---|---|
| K172384 | K083017 | |
| The Sunrise Medical Quickie®Q700-UP M power wheelchairsare battery operated devices, | The LEVO C3 powerwheelchairwith optional seating and | Equivalent |
Table 1. Primary Predicate Comparison of Indications For Use
{5}------------------------------------------------
| that are indicated for medicalpurposes to provide mobilityand repositioning of the user,including a stand-up feature. | standing position function maybe of interest for any individualswho needs a power wheelchairand cannot stand up on theirown such as people with spinalcord injury, spina bifida,cerebralpalsy, multiple sclerosis, | |
|---|---|---|
| muscular dystrophy, polio. | ||
| rheumatism, etc.. |
Principles of Operation
Sunrise Medical power wheelchairs use components tvpically found on most wheelchairs, including but not limited to rigid seat frame, backrest, push handles, armrests, cushion, footrests and casters. The wheelchair can be customized with various optional add-ons. Accessories that may be added after-market include items such as positioning belts, backpacks, seat pouches, oxygen tank holders and IV poles. The Sunrise Medical power wheelchairs are center-wheel-drive power wheelchairs which will perform optimally on firm even surfaces such as concrete, asphalt and indoor flooring.
The braking system can be initiated by either automatic or electric means. The brakes are automatically on except when the wheelchair is turned on and the joystick has been moved away from the neutral position. When the joystick is released or moved back to neutral, the brakes engage again. If the electrical brake system fails, the brakes will default to the closed, or "brakes on" position, thereby stopping the wheelchair. A control system (i.e., controller and joystick) controls motor, brakes, drive wheel and batteries. This product is appropriate for use by any individual who can drive a power wheelchair without having to utilize the services of an attendant. In addition, the controls give the optional capability for attendant controller is fully programmable.
The new feature for this model, the Quickie® Q700-UP M, is the ability for the patient to stand up, completely or partially, to facilitate reaching, working eye to eye with colleagues and provide more comfortable resting positions.
The actuator added for this feature articulates the chair (under the joystick's control) and seating to allow the patient position to come to a standing position if desired. The seating, straps, knee brace and leg rests stabilize the patient so they do not slip down and slump during the stand-sit or sit-stand operation.
Predicate Comparison of Major Technical Features
{6}------------------------------------------------
The following tables provides a comparison of the primary predicate device (Levo C3 – Table 2) and the reference device (Quickie Pulse 6SC - Table 3) with the QM700-UP M to demonstrate substantial equivalence.
| Feature | PrimaryPredicate: LevoC3 PowerWheelchair | Q700-UP M PowerWheelchair | Comparison |
|---|---|---|---|
| 510(k) Number | K083017 | K172384 | |
| Product Code | IPL 890.3900 | IPL 890.3900 | Identical |
| Device Description | The LEVO C3 withoptionalseating andstanding positionfunction is centerwheel driven,battery powered,motor drivenpower wheelchairand iscontrolled by thePG DrivesTechnology'spower wheelchaircontroller "VR2".The joystick isintegrated in thecontroller. Thewheelchair ispowered by two12V/55Ah or two12V/72Ahbatteries with atheoreticaldriving range of25km (55Ah),35km (72Ah). TheLEVO C3power wheelchair isa productwhich changespeople's positionin/from seating or/tostanding but | Q700-UP Mpoweredwheelchairs:• Are center-wheel-drive powerwheelchairs• Perform optimallyon firmeven surfaces suchasconcrete, asphaltand indoorflooring• Designed to:- Overcome amaximumobstacle height of2.5" (not instanding mode)- Operate at amaximum inclineangle for safeoperation of 10°(not in standingmode)- Travel a maximumdistance of21 miles on fullychargedbattery- Work indoors andout at carefacilities and privateresidences | Equivalent |
| also any position inbetween.The electricalpositioning changeis integrated in anelectricalcenter wheel drivepowerwheelchair thatperforms highindoor and outdoormobility inany optionalpossible position.For security, thespeed isreduced to halfspeed as soonas the patient is not | - The wheelchair ispowered by2 12V Group 24 orGroup 34batteries- It is controlled byPG DrivesTechnology'spowerwheelchaircontroller "R-Net"and has a slow"Creep Mode"speed when in the | ||
| Picture (in standingmode) | Image: Wheelchair in standing mode | Image: Wheelchair in standing mode | Equivalent |
| Seat width | 12.6 - 20.5 inches | 16 – 22" | Equivalent |
| Total width | 24.8 inches | 25" | Equivalent |
| Total length | 41.3 inches | 36" | FunctionallyEquivalent |
| Seat plate depth | 13.8–24.8 inches | 16 – 22" | FunctionallyEquivalent |
| Armrest height | 5.9-14.1 inches | 6.3"-12" | FunctionallyEquivalent |
| Turning circle | 43 inches | 43 inches | Identical |
| Speed | 3.7/ 5 /6.2 mphoptions | 6 or 8 mph options | FunctionallyEquivalent |
| Range (with 55 AhrBatteries) | 15.5 miles | 21 miles | FunctionallyEquivalent |
| Manageablegradient | 15° (33%) actually28% | 10° (18%) | FunctionallyEquivalent |
| Max. curb height | 4 inches | 4 inches | Identical |
| Max. chair weight | 407 lbs. | 375 lbs. | Equivalent |
| Max. user weight | 310 lbs. | 265 lbs. | Reduced weightcapacity |
| Transport volumemax. | 37.8 x 24.8 x 27.1inches | 41 "x 25"x 29" | FunctionallyEquivalent |
Table 2. Predicate Comparison with the Primary Predicate
{7}------------------------------------------------
{8}------------------------------------------------
| Controller(s) | PGDT VR-2Controller Std.PGDT R-NetController Optional | PGDT R-NetController Std. | Equivalent |
|---|---|---|---|
| Joystick Mounting | StandardSwing-awayRetractable | StandardSwing-awayRetractable | Equivalent |
| Attendant Controls | Optional, for VR-2or R-Net | Optional, for R-Net | Equivalent |
| Batteries | Group 22Sealedlead — 48 AHGroup 24SealedGel — 73 AH | Group 24 – 73AhrGroup 34 -50 Ahr | Equivalent |
| Power stand-upfeature | Requires chestsupport andknee supportoptions | Chest support andkneesupport standard | Identical |
| Light kit option: | Front & Rear withTurn Signal | Front & Rear withTurn Signal | Identical |
Table 3. Comparison with the Reference Device
| Feature | Reference Device:Quickie Pulse 6SC | Q700-UP M PowerWheelchair | Comparison |
|---|---|---|---|
| 510(k) Number | K 142457 | K 172384 | |
| Product Code | ITI 890.3860 | IPL 890.3900 | Additional stand-upfeature |
| GENERAL | |||
| User Weight (Max) | 300 lb. | 265 lb. | Equivalent(limited by standupfeature) |
| Structural Materials | Steel andaluminum framestructure which iswelded andpowder coated andutilizesstandard foamsand covers forthe seat. | Steel and aluminumframestructure which iswelded andpowder coated andutilizesstandard foams andcovers forthe seat. | Identical |
| Biocompatibility | Uses materialscommon to manyWheelchairs. | Uses materialscommon to manyWheelchairs. | Identical |
| Maximum speed | 6.0 mph forQuickie® Pulse6SCpower wheelchairs | 6.0 mph, with 8.0mph option | Equivalent |
| BASE | |||
| Overall dimensions(width x length) | 24" x 34" | 25" x 36" | Equivalent |
| Maximum totalweight of base | 130 lbs. | 152 lbs. | Equivalent |
| Batteries | 22NF, 52 Ahrsealed lead acid orgel cellbatteries | 24V (2x12V) / 73Ah/20h.Maintenance freeor24V (2x12V) / 60Ah/20h.Maintenance free | Equivalent |
| Drive wheels | 13" diameter | 14" diameter | Equivalent |
| Caster wheels | 7" front, 6" rear | 6" Front & Rear | Equivalent |
| Motors/gearbox | DC PermanentMagnet motorwith gearboxOutput speed:163rpmGear ratio: 26:1Peak power: 910 W@ 90A | 6.0 Motor PackageOutput Speed: 163rpmGear Ratio: 26:1Peak Power:1026W@120A8.0 mph MotorPackage:Output speed: 220rpmGear Ratio: 26:1Peak Power:1293W @120A | Equivalent |
| Anti-pitchmechanism forclimbing | Additional anti-pitchlock-out. | Additional anti-pitchlock-out. | Equivalent |
| Cosmetic | Product is madefrom a steeltubular box frame,with castaluminum front andrear casterarms and shroudedwith ABSplastic covers | Product is madefrom a steeltubular box frame,with castaluminum front andrear casterarms and shroudedwith ABSplastic covers | Equivalent |
| Picture | Equivalent | ||
| Seat options | Standard rehab seat(accommodates after-market seating).Captain's seat.Comes with cushions andupholstery. | SEDEO UP Recline(required by stand-up feature) | Equivalent |
| Minimum seatheight | 16.2" | 16.2" | Identical |
| Lift, tilt, reclinerange | Lift range 0-12"Tilt range 0-50°Recline range 0-172° | Lift range 0-12"Tilt range 0-50°Recline range 0-172° | Identical |
| Lift, tilt, reclinecapacity | Lift capacity 300lbs.Tilt capacity 300lbs.Recline capacity250 lbs. | Lift capacity 265lbs.Tilt capacity 265lbs.Recline capacity265 lbs. | Equivalent (limitedby stand-upfeature) |
| Seat dimensions | Width 12-24"Depth 12-22" | Width 16 - 22"Depth 16 - 22" | Equivalent |
| CONTROLLER | |||
| Controller type | VR2 from PGDT(standard)R-Net from PGDT(optional) | R-Net from PGDT | Equivalent (limitedby stand-upfeature) |
| Supply voltage | 24 V dc | 24 V dc | Identical |
| Operating voltage | 35 V dc | 35 V dc | Identical |
| Reverse batteryvoltage | -40 V dc | -40 V dc | Identical |
| PWM frequency | 19.5 kHz ± 1% | 19.5 kHz ± 1% | Identical |
| Brake voltage | Harness with in-lineconnector | Harness with in-lineconnector | Identical |
| Brake current | Minimum 100 mAMaximum 1 A | Minimum 100 mAMaximum 1 A | Identical |
| Charging current | 12 A rms max | 12 A rms max | Identical |
| Charger connection | Only Neutrik NC3MX | Only Neutrik NC3MX | Identical |
| Actuator current | Maximum 10 A | Maximum 10 A | Identical |
| Maximum drive current | VR290: 90AR-Net EL 90: 90A | RNet 120A Controller | Equivalent with additional max current output. |
| Moisture resistance | Compliant with ANSI RESNA WC-9 | Compliant with ANSI RESNA WC-9 | Identical |
| Operating temperature | -25°C to 50°C | -25°C to 50°C | Identical |
| Storage temperature | -40°C to 70°C | -40°C to 70°C | Identical |
| Joystick Mount | Fixed mount (standard)Height adjustable (standard)Swing-away (option) | Fixed mount (standard)Height adjustable (standard)Swing-away (option) | Identical |
| Controller Connector | Harness with in-line connector | Harness with in-line connector | Identical |
| USER INPUT CONTROLS | |||
| Number of drive profiles | 5 | 5 | Identical |
| User input | Joystick and hand control buttons | Joystick and hand control buttons | Identical |
| On/off button | Yes | Yes | Identical |
| Speed up / speed down buttons | Yes | Yes | Identical |
| Horn button | Yes | Yes | Identical |
| Actuator control | Versions available with and without actuator control buttons | Versions available with and without actuator control buttons | Identical |
| Number of actuators for lift, tilt, recline | 2 | 6 - tilt, stand-up, recline (2), power legrests (2), lift. | Equivalent |
| Battery state indicator | LEDs | LEDs | Identical |
| Electronics package | Electronics in both hand control module and motor control module | Electronics in both hand control module and motor control module | Identical |
| Programming tool | Hand heldprogrammer | Hand heldprogrammer | Identical |
| External driveinhibit input | Yes | Yes | Identical |
| Attendant control | Option with R-Netsystem | Option with R-Netsystem | Identical |
| Bluetooth PCmouse replacement | Option with R-Netsystem | Option with R-Netsystem | Identical |
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
{12}------------------------------------------------
Use of Standards
The table below (Table 4) provides a summary of all the various standards to which the Q700-UP M conforms.
Table 4. List of recognized standards to which the Q700-UP M Complies
| Recognized Standard | Outcome |
|---|---|
| ISO 7176-1 [ANSI/RESNA WC-1/1]: Determination of StaticStability | Pass |
| ISO 7176-2 [ANSI/RESNA WC-2/2]: Determination of DynamicStability of Electrically Powered Wheelchairs | Pass |
| ISO 7176-3 [ANSI/RESNA WC-2/3]: Determination ofeffectiveness of brakes | Pass |
| ISO 7176-4 [ANSI/RESNA WC-2/4]: Energy consumption ofelectrically powered wheelchairs and scooters for determinationof theoretical distance | Pass |
| ISO 7176-5 [ANSI/RESNA WC-1/5]: Determination ofdimensions, mass and maneuvering space | Pass |
| ISO 7176-6 [ANSI/RESNA WC-2/6]: Determination ofmaximum speed, acceleration and deceleration of electricallypowered wheelchairs | Pass |
| ISO 7176-7 [ANSI/RESNA WC-1/7]: Method of measurementof seating and wheel dimensions | Pass |
| ISO 7176-8 [ANSI/RESNA WC-1/8]: Requirements and testmethods for static, impact and fatigue strengths | Pass |
| ISO 7176-9 [ANSI/RESNA WC-2/9]: Climatic tests forelectrically powered wheelchairs | Pass |
| ISO 7176-10 [ANSI/RESNA WC-2/10]: Determination ofobstacle-climbing ability of electrically powered wheelchairs | Pass |
| ISO 7176-14 [ANSI/RESNA WC-2/14]: Power and controlsystems for electrically powered wheelchairs - Requirementsand test methods | Pass |
| ISO 7176-15 [ANSI/RESNA WC-1/15]: Requirements forinformation disclosure, documentation and labeling | Pass |
| ISO 7176-16 [ANSI/RESNA WC-1/16]: Resistance to ignition ofupholstered parts - Requirements and test methods | Pass |
{13}------------------------------------------------
| ISO 7176-19 [ANSI/RESNA WC-4/19]: Wheeled mobilitydevices for use as seats in motor vehicles | Pass |
|---|---|
| ISO 7176-21 [ANSI/RESNA WC-2/21]: Requirements and testmethods for electromagnetic compatibility of electricallypowered wheelchairs and motorized scooters | Pass |
| ISO 10993-5: Biological evaluation of medical devices | Pass |
| ISO 7176-25: Batteries and chargers for powered wheelchairsand motorized scooters - Requirements and test methods | Pass |
| RESNA WC-1:2009 Section 20: Determination of thePerformance of Stand-up Type Wheelchairs | Pass |
Clinical Testing and/or Non-Clinical Testing
No Clinical Testing is required for this submission
Conclusion
All verification and validation testing conducted demonstrate that the Quickie® Q700-UP M is substantially equivalent to the primary predicate device:
| Primary Predicate Device: | Levo C3 Power WheelchairK083017Product Code IPL21 CFR 890.3900 |
|---|---|
| Reference Device: | Sunrise Medical Quickie® Pulse 6SCK142457Product Code ITI21 CFR 890.3860 |
§ 890.3900 Standup wheelchair.
(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).