(161 days)
No
The description focuses on mechanical and electronic components for mobility and standing, with no mention of AI or ML technologies.
No
Explanation: While the device is indicated for medical purposes to provide mobility and repositioning, its primary function is assistive, not therapeutic. It doesn't actively treat or cure a medical condition but rather aids in overcoming a physical limitation.
No
This device is a power wheelchair indicated for mobility and repositioning of the user, not for diagnosing medical conditions.
No
The device description explicitly lists multiple hardware components, including actuators, control modules, and a caster/suspension lock-out system, which are integral to the device's function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Sunrise Medical Quickie® Q700-UP M power wheelchair is a battery-operated device for providing mobility and repositioning, including a stand-up feature. It is a physical device used to assist a user with movement and posture.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from the user. Its function is purely mechanical and related to physical support and movement.
Therefore, the Quickie® Q700-UP M power wheelchair falls under the category of a medical device for mobility and support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
IPL
Device Description
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. 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.
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)
No Clinical Testing is required for this submission.
The Q700-UP M product conforms to various ISO and RESNA standards.
Key results from Table 2: Predicate Comparison with the Primary Predicate (Levo C3) are that the Q700-UP M is Equivalent or Functionally Equivalent across most features, with identical product code and turning circle, but reduced max user weight capacity.
Key results from Table 3: Comparison with the Reference Device (Quickie Pulse 6SC) are that it has an additional stand-up feature, equivalent user weight (limited by standup feature), identical structural materials, biocompatibility, overall dimensions are equivalent, batteries are equivalent, drive wheels are equivalent, caster wheels are equivalent, motors/gearbox are equivalent, anti-pitch mechanism for climbing is identical, cosmetic features are identical, seat options are equivalent, minimum seat height is identical, lift/tilt/recline range is identical, lift/tilt/recline capacity is equivalent (limited by stand-up feature), seat dimensions are equivalent, controller type is equivalent (limited by stand-up feature), supply voltage, operating voltage, reverse battery voltage, PWM frequency, brake voltage, brake current, charging current, charger connection, actuator current, maximum drive current, moisture resistance, operating temperature, storage temperature, joystick mount, controller connector, number of drive profiles, user input, on/off button, speed up/speed down buttons, horn button, actuator control, battery state indicator, electronics package, programming tool, external drive inhibit input, attendant control, and bluetooth PC mouse replacement are all identical.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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 Gertlar
Sunrise Medical (US) LLC
2842 Business Park Ave
Fresno, CA 93727
Phone: 559-294-2395
Fax: 559-348-2505 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Nancy J Gertlar
Senior Director Regulatory Affairs and Quality Assurance
Nancy.gertlar@sunrise.com |
| Date Summary Prepared: | December 1, 2017 |
| Trade Name: | Quickie® Q700-UP M |
| : Common/
Classification Name: | Wheelchair, Standup
Standup wheelchair |
| Product Code | IPL
21 CFR 380.3900 |
| Primary Predicate Device: | Levo C3 Power Wheelchair
K083017
Product Code IPL
21 CFR 890.3900 |
| Reference Device: | Sunrise Medical Quickie® Pulse 6SC
K142457
Product 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 wheelchairs | ||
| are battery operated devices, | The LEVO C3 power | |
| wheelchair | ||
| with optional seating and | Equivalent |
Table 1. Primary Predicate Comparison of Indications For Use
5
| that are indicated for medical
purposes to provide mobility
and repositioning of the user,
including a stand-up feature. | standing position function may
be of interest for any individuals
who needs a power wheelchair
and cannot stand up on their
own such as people with spinal
cord injury, spina bifida,
cerebral
palsy, 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 | Primary
Predicate: Levo
C3 Power
Wheelchair | Q700-UP M Power
Wheelchair | Comparison |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| 510(k) Number | K083017 | K172384 | |
| Product Code | IPL 890.3900 | IPL 890.3900 | Identical |
| Device Description | The LEVO C3 with
optional
seating and
standing position
function is center
wheel driven,
battery powered,
motor driven
power wheelchair
and is
controlled by the
PG Drives
Technology's
power wheelchair
controller "VR2".
The joystick is
integrated in the
controller. The
wheelchair is
powered by two
12V/55Ah or two
12V/72Ah
batteries with a
theoretical
driving range of
25km (55Ah),
35km (72Ah). The
LEVO C3
power wheelchair is
a product
which changes
people's position
in/from seating or/to
standing but | Q700-UP M
powered
wheelchairs:
• Are center-wheel-
drive power
wheelchairs
• Perform optimally
on firm
even surfaces such
as
concrete, asphalt
and indoor
flooring
• Designed to:
- Overcome a
maximum
obstacle height of
2.5" (not in
standing mode) - Operate at a
maximum incline
angle for safe
operation of 10°
(not in standing
mode) - Travel a maximum
distance of
21 miles on fully
charged
battery - Work indoors and
out at care
facilities and private
residences | Equivalent |
| | also any position in
between.
The electrical
positioning change
is integrated in an
electrical
center wheel drive
power
wheelchair that
performs high
indoor and outdoor
mobility in
any optional
possible position.
For security, the
speed is
reduced to half
speed as soon
as the patient is not | - The wheelchair is
powered by
2 12V Group 24 or
Group 34
batteries - It is controlled by
PG Drives
Technology's
power
wheelchair
controller "R-Net"
and has a slow
"Creep Mode"
speed when in the | |
| Picture (in standing
mode) | 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" | Functionally
Equivalent |
| Seat plate depth | 13.8–24.8 inches | 16 – 22" | Functionally
Equivalent |
| Armrest height | 5.9-14.1 inches | 6.3"-12" | Functionally
Equivalent |
| Turning circle | 43 inches | 43 inches | Identical |
| Speed | 3.7/ 5 /6.2 mph
options | 6 or 8 mph options | Functionally
Equivalent |
| Range (with 55 Ahr
Batteries) | 15.5 miles | 21 miles | Functionally
Equivalent |
| Manageable
gradient | 15° (33%) actually
28% | 10° (18%) | Functionally
Equivalent |
| Max. curb height | 4 inches | 4 inches | Identical |
| Max. chair weight | 407 lbs. | 375 lbs. | Equivalent |
| Max. user weight | 310 lbs. | 265 lbs. | Reduced weight
capacity |
| Transport volume
max. | 37.8 x 24.8 x 27.1
inches | 41 "x 25"x 29" | Functionally
Equivalent |
Table 2. Predicate Comparison with the Primary Predicate
7
8
| Controller(s) | PGDT VR-2
Controller Std.
PGDT R-Net
Controller Optional | PGDT R-Net
Controller Std. | Equivalent |
|---------------------------|-------------------------------------------------------------------|-----------------------------------------------|------------|
| Joystick Mounting | Standard
Swing-away
Retractable | Standard
Swing-away
Retractable | Equivalent |
| Attendant Controls | Optional, for VR-2
or R-Net | Optional, for R-Net | Equivalent |
| Batteries | Group 22Sealed
lead — 48 AH
Group 24Sealed
Gel — 73 AH | Group 24 – 73Ahr
Group 34 -50 Ahr | Equivalent |
| Power stand-up
feature | Requires chest
support and
knee support
options | Chest support and
knee
support standard | Identical |
| Light kit option: | Front & Rear with
Turn Signal | Front & Rear with
Turn Signal | Identical |
Table 3. Comparison with the Reference Device
| Feature | Reference Device:
Quickie Pulse 6SC | Q700-UP M Power
Wheelchair | Comparison |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| 510(k) Number | K 142457 | K 172384 | |
| Product Code | ITI 890.3860 | IPL 890.3900 | Additional stand-up
feature |
| GENERAL | | | |
| User Weight (Max) | 300 lb. | 265 lb. | Equivalent
(limited by standup
feature) |
| Structural Materials | Steel and
aluminum frame
structure which is
welded and
powder coated and
utilizes
standard foams
and covers for
the seat. | Steel and aluminum
frame
structure which is
welded and
powder coated and
utilizes
standard foams and
covers for
the seat. | Identical |
| Biocompatibility | Uses materials
common to many
Wheelchairs. | Uses materials
common to many
Wheelchairs. | Identical |
| Maximum speed | 6.0 mph for
Quickie® Pulse
6SC
power wheelchairs | 6.0 mph, with 8.0
mph option | Equivalent |
| BASE | | | |
| Overall dimensions
(width x length) | 24" x 34" | 25" x 36" | Equivalent |
| Maximum total
weight of base | 130 lbs. | 152 lbs. | Equivalent |
| Batteries | 22NF, 52 Ahr
sealed lead acid or
gel cell
batteries | 24V (2x12V) / 73
Ah/20h.
Maintenance free
or
24V (2x12V) / 60
Ah/20h.
Maintenance free | Equivalent |
| Drive wheels | 13" diameter | 14" diameter | Equivalent |
| Caster wheels | 7" front, 6" rear | 6" Front & Rear | Equivalent |
| Motors/gearbox | DC Permanent
Magnet motor
with gearbox
Output speed:
163rpm
Gear ratio: 26:1
Peak power: 910 W
@ 90A | 6.0 Motor Package
Output Speed: 163
rpm
Gear Ratio: 26:1
Peak Power:1026W
@120A
8.0 mph Motor
Package:
Output speed: 220
rpm
Gear Ratio: 26:1
Peak Power:
1293W @120A | Equivalent |
| Anti-pitch
mechanism for
climbing | Additional anti-pitch
lock-out. | Additional anti-pitch
lock-out. | Equivalent |
| Cosmetic | Product is made
from a steel
tubular box frame,
with cast
aluminum front and
rear caster
arms and shrouded
with ABS
plastic covers | Product is made
from a steel
tubular box frame,
with cast
aluminum front and
rear caster
arms and shrouded
with ABS
plastic covers | Equivalent |
| Picture | | | Equivalent |
| | | | |
| Seat options | Standard rehab seat
(accommodates after-market seating).
Captain's seat.
Comes with cushions and
upholstery. | SEDEO UP Recline
(required by stand-up feature) | Equivalent |
| Minimum seat
height | 16.2" | 16.2" | Identical |
| Lift, tilt, recline
range | 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, recline
capacity | Lift capacity 300
lbs.
Tilt capacity 300
lbs.
Recline capacity
250 lbs. | Lift capacity 265
lbs.
Tilt capacity 265
lbs.
Recline capacity
265 lbs. | Equivalent (limited
by stand-up
feature) |
| 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 (limited
by stand-up
feature) |
| Supply voltage | 24 V dc | 24 V dc | Identical |
| Operating voltage | 35 V dc | 35 V dc | Identical |
| Reverse battery
voltage | -40 V dc | -40 V dc | Identical |
| PWM frequency | 19.5 kHz ± 1% | 19.5 kHz ± 1% | Identical |
| Brake voltage | Harness with in-line
connector | Harness with in-line
connector | Identical |
| Brake current | Minimum 100 mA
Maximum 1 A | Minimum 100 mA
Maximum 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: 90A
R-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 held
programmer | Hand held
programmer | Identical |
| External drive
inhibit input | Yes | Yes | Identical |
| Attendant control | Option with R-Net
system | Option with R-Net
system | Identical |
| Bluetooth PC
mouse replacement | Option with R-Net
system | Option with R-Net
system | 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 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 of | |
| electrically powered wheelchairs and scooters 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 of electrically | |
| powered wheelchairs | 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 of electrically powered wheelchairs | Pass |
| ISO 7176-14 [ANSI/RESNA WC-2/14]: Power and control | |
| systems for electrically powered wheelchairs - 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 - Requirements and test methods | Pass |
13
| 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]: Requirements and test | |
| methods for electromagnetic compatibility of electrically | |
| powered wheelchairs and motorized scooters | Pass |
| ISO 10993-5: Biological evaluation of medical devices | Pass |
| ISO 7176-25: Batteries and chargers for powered wheelchairs | |
| and motorized scooters - Requirements and test methods | Pass |
| RESNA WC-1:2009 Section 20: Determination of the | |
| Performance 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 Wheelchair
K083017
Product Code IPL
21 CFR 890.3900 |
|---------------------------|--------------------------------------------------------------------------------------|
| Reference Device: | Sunrise Medical Quickie® Pulse 6SC
K142457
Product Code ITI
21 CFR 890.3860 |