(258 days)
PDG Inc. Fuze T20
Not Found
No
The description details a purely mechanical wheelchair with manual operation by a caregiver. There is no mention of any computational or data-driven components that would suggest AI/ML.
No
The device is a wheelchair intended to provide mobility, not to treat or cure a medical condition. While it offers adjustability for optimal positioning, this is a comfort feature rather than a therapeutic intervention.
No
This device is a wheelchair designed to provide mobility and support for individuals, not to diagnose medical conditions.
No
The device description clearly describes a mechanical wheelchair with a rigid aluminum frame, gas springs, and manual operation, indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide mobility to persons limited to a sitting position." This is a physical function, not a diagnostic one.
- Device Description: The description details a mechanical wheelchair with features for positioning and mobility. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Detecting or measuring substances in the body.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Performance Studies: The performance studies focus on the physical aspects of the wheelchair (stability, fatigue, strength) and adherence to mobility standards (ANSI/RESNA WC/Vol.1). They do not involve clinical diagnostic performance metrics.
In summary, the Future Mobility Healthcare Inc. Capella wheelchair is a medical device intended for mobility assistance, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
The Future Mobility Healthcare Inc. Capella wheelchair is intended to provide mobility to persons limited to a sitting position.
Product codes
IOR
Device Description
Dynamic tilt in space mechanical wheelchair which offers adjustability to redistribute the body weight for optimal positioning. The tilting is operated by the care-giver in the back handles of the chair. The Capella/Capella 45 can accommodate different size occupants. The seat width and depth can be ordered in several sizes.
The Capella/Capella 45 is constructed of a rigid, aluminum frame with anti-tippers and the ability to tilt and manual recline. Depending on the seat depths, it has a capacity to support a human weight of 350lbs (250lbs Capella45). One gas spring is used to lift and decline the seat and back to the tilting positions in the Capella 45. And the Capella uses two gas springs. The gas spring(s) are connected by cables to levers on the push bar so that they can be locked and unlocked by the caregiver.
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 Capella/Capella45 has been designed and tested according to the ANSI/RESNA WC/Vol.1. All results are satisfactory and meet the standards indicated from ANSI/RESNA WC/Vol.1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PDG Inc. Fuze T20
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).
0
Future Mobility Healthcare Inc. FDA Submittal - 510(k) CAPELLA .
K130788
510(k) Summary
Submitted by:
Future Mobility HealthCare Inc. 3223 Orlando Drive Mississauga. ON, L4V IC5 Tel. (1-888-737-4011)
DEC 0 5 2013
Contact:
Mr. Abdul Panchbhaya Toll Free: 1-888-737-4011. Local: 905-671-1661 asif?@futuremobility.ca
Date: Sept., 2013
Trade Name: Capella Dynamic Tilting, and Capella 45 variant, mechanical wheelchair
Common Name: Manual Wheelchair
Classification Name: Wheelchair. Mechanical
Regulation Number: 890.3850
Predicate Devices: PDG Inc. Fuze T20
1
Future I
Future Mobility Healthcare Inc. FDA Submittal - 510(k) CAPELLA
Table of Comparison to Legally Marketed devices and effect of differences on safety and effectiveness . ·
| ITEM | Legally marketed:
PDG Inc. Fuze T20 | Future Mobility
Healthcare.Inc.
Capella/Capella 45 | Impact on safety and
effectiveness |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The PDG Fuze T20 is
indicated for providing
mobility to persons
limited to a sitting
position. | The Capella/Capella
45 is indicated for
providing mobility to
person limited to a
sitting position. | The indicated use for
devices is identical. |
| Manufacturer | PDG Product Design
Inc. | Future Mobility
Healthcare Inc. | n/a |
| K Number | K063736 | K130788 | n/a |
| Product Code: | IOR | IOR | n/a |
| FDA Product Class | 1 | 1 | n/a |
| Product Description | Dynamic tilt in space
mechanical wheelchair
which offers
adjustability to
redistribute the body
weight for optimal
positioning. The tilting
is operated by the
care-giver in the back
handles of the chair.
The Fuze T20 can
accommodate different
size occupants. The
seat width and depth
can be ordered in
several sizes. | Dynamic tilt in space
mechanical wheelchair
which offers
adjustability to
redistribute the body
weight for optimal
positioning. The tilting
is operated by the
care-giver in the back
handles of the chair.
The Capella/Capella
45 can accommodate
different size
occupants. The seat
width and depth can be
ordered in several
sizes. | All devices are
designed with similar
functions and the
Capella/Capella 45 has
no features that impact
the safety and
effectiveness of the
predicate devices. |
| Intended surface for
the operation | To be operated on all
surfaces except rough
surfaces | To be operated on all
surfaces except rough
surfaces | Unites are intended for
same surface of
operation |
| Safety Characteristics | Spring return push to
lock wheel lock, anti-
tippers | Spring return push to
lock wheel lock, anti-
tippers | All have the safety
requirements for a
mechanical
wheelchair. This
includes anti-tipper |
| | | | fixtures, wheel locking
mechanism and a rigid
body frame for
resistance to fatigue,
shear, as well as
impact forces. The
Capella/Capella45 has
been designed and
tested according to the
ANSI/RESNA
WC/Vol.1. All results
are satisfactory and
meet the standards
indicated from
ANSI/RESNA
WC/Vol.1 |
| Performance /
Function | | | |
| Overall function and
physical characteristics | The Fuze T20 is
constructed of a rigid,
aluminum frame with
anti-tippers and the
ability to tilt and
manual recline.
Depending on the seat
depths, it has a
capacity to support a
human weight of
250lbs. One gas spring
is used to lift an
ddecline the seat and
back to the tilting
positions. The gas
spring is connected by
cables to levers on the
push bar so that it can
be locked and
unlocked by the
caregiver. | The Capella/Capella
45 is constructed of a
rigid, aluminum frame
with anti-tippers and
the ability to tilt and
manual recline.
Depending on the seat
depths, it has a
capacity to support a
human weight of
350lbs (250lbs
Capella45). One gas
spring is used to lift an
ddecline the seat and
back to the tilting
positions in the
Capella 45. And the
Capella uses two gas
springs. The gas
spring(s) are
connected by cables to
levers on the push bar
so that they can be
locked and unlocked | The Capella has the
same overall function
and physical
characteristics of a
mechanical tilt in
space wheelchair. It
uses two gas cylinders
to tilt the user with the
controls located on the
stroller bars. The
Capella 45 similarly
uses just one gas
cylinder. |
| Tilt | 20 deg | by the caregiver.
17deg Capella. 44 deg
Capella 45 | All devices have tilt
capability. The resting
state for the static
stability test has been
performed on all to
indicate that the tilt
does not create any
stability problems. |
| Fixed recline | 0 to 30 degrees | -7 to +21 degrees (28
degrees) | All devices have
similar degree of fixed
recline capability of up
to 30 deg. And 28 deg.
Respectively. The
standard chair resting
state is at +7 deg
recline. |
| Seat width | 13-20" | 16-24" | No impact on safety
and effectiveness. Test
results are satisfactory. |
| Seat depth | 15-20" | 15-20" | Seat depth is similar
and no impact to
safety. Test results are
satisfactory. |
| Seat-to-floor height | 13-20" (front) | 13-19" (front) | Wheelchairs are
comparable in height
and the difference
should not have a
bearing on safety and
effectiveness. |
| Adjustable arm heights | 10 to 14" | 9.5 to 14" | This does not have an
impact on
effectiveness nor
safety. |
| Front riggings | 70 and 90 deg | 60.70.80.90 deg | No impact on safety
and effectiveness |
| Back post heights | 20 and 25" | 19" and 24" | No impact on safety
and effectiveness |
| Rear wheel sizes | 12.16.20.22.24 | 16,20.22.24 | Various sizes are
offered depending on
end users preference.
Each wheel size has |
| | | | |
| | | | been evaluated by
Future Mobility for
stability and strength
with satisfactory
results |
| Caster Sizes | 5.6. or 8" | 5.6.7. or 8" | Various sizes are
offered depending on
end users preference.
No impact on safety as
each caster size has
been evaluated by
Future Mobility. |
| Chair width | For 12 and 16" rear
wheels seat width is
+9.5" for 20.22.24"
rear wheels seat width
is +10.75" | Seat width +10.75" | Does not have any
impact to
effectiveness. Safety
has been evaluated to
be satisfactory |
| Chair length | 28" no riggings | 31" no riggings | No impact on safety
and effectiveness |
| Overall length | 42" | 45" | No impact on safety
and effectiveness |
| Maximum human
support weight | 250lbs | 350lbs (Capella)
250lbs (Capella45) | All chairs passed
safety, stability.
fatigue and strength
tests. |
| Overall function and
physical characteristics | The Fuze T20 is
constructed of a rigid
aluminum frame with
anti-tippers and the
ability to tilt and
manual recline. It has a
capacity to support a
human weight of
250lbs | The Capella (and
Capella45) is
constructed of a rigid
aluminum frame with
anti-tippers and the
ability to tilt and
manual recline. It has a
capacity to support a
human weight of
350lbs (250lbs Capella
45) | All have the same
overall function and
physical characteristics
of a mechanical tilt in
space wheelchair. |
| Materials | Fuze T20 material
meet the California
Technical Bulletin
CAL177 standard for
flame retardant. | The material used on
the Capella/Capella45
back rests and seat
cushions meet the
California Technical
Bulletin CAL 177 | Both wheelchairs meet
the flammability
standards of CAL 177.
No impact on safety
and effectiveness. |
| | | standard for flame
retardant. | |
| Prescription use or
over the counter | Over the counter | Over the counter | No impact to safety
and effectiveness |
| Gas spring | The Fuze T20 utilizes
a single centre
positioned locking gas
spring to operate the
lift and decline of the
seat. | The Capella utilizes
two locking gas
springs in tandem
parallel configuration
to operate the lift and
decline of the seat. The
Capella 45 utilizes a
single centre
positioned locking gas
spring to operate the
lift and decline of the
seat. | No impact to the
safety and
effectiveness. |
.
2
Image /page/2/Picture/0 description: The image shows the logo for Future Mobility Healthcare Inc. The logo is in black and white and features a stylized wheelchair graphic above the word "Mobility". The text is slightly distorted, giving it a textured appearance.
Future Mobility Healtheare Inc. FDA Submittal - 510(k) CAPELLA
.
3
Future Mobility Healthcare Inc. FDA Submittal - 510(k) CAPELLA
1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 -
·
4
Image /page/4/Picture/0 description: The image shows the logo for Future Mobility Healthcare Inc. The logo is in black and white and features a stylized wheelchair above the word "Mobility". The text is in a blocky, slightly distressed font, giving it a unique and somewhat vintage appearance.
Future Mobility Healthcare Inc. FDA Submittal - 510(k) CAPELLA
5
Future A ne.
Future Mobility Healthcare Inc.
FIDA Submittal - 510(k) CAPELLA ・
·
.
6
Image /page/6/Picture/0 description: The image shows the logo for Future Mobility Healthcare Inc. The logo features the words "Future Mobility" in a bold, sans-serif font, with a stylized wheelchair graphic incorporated into the word "Mobility". Below this, the words "Healthcare Inc." are printed in a similar font, completing the company name.
Future Mobility Healthcare Inc. FDA Submittal - 510(k) CAPELLA
The rationale of declaring the Future Mobility Healthcare Capella wheelchair is substantially equivalent to the above predicate devices is based on the following:
- Same Indications for use: providing mobility to persons limited to a sitting position.
-
Similar kev design technical characteristics- the Fuze T20 and Capella are mechanical wheelchairs which have technical similarities.
- The Fuze T20 and Capella Dynamic tilt, and Capella 45. wheelehairs are manually operated, self propelled mechanical wheelchairs, and may also be used as attendant propelled transport devices. They consist of aluminum frames for use by patients weighing up to 250 lbs and 350 lbs. respectively.
Conclusion:
Future Mobility Healtheare Capella Dynamic Tilt mechanical wheelchair was developed in accordance with ISO 7176. parts 1. 5. 7. 8. 11. 13. and 15. It is the conclusion that the Future Mobility HealthCare Capella wheelchair is safe and effective, as well as substantially equivalent to the legally marketed device identified as the predicate devices.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hamoshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 5, 2013
Future Mobility Healthcare c/o Abdulsamad Panchbhaya, President and CEO 3223 Orlando Drive Mississauga, ON L4V IC5
Re: K130788
Trade/Device Name: Capella Dynamic Tilt and Capella 45 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: October 18, 2013 Received: October 18, 2013
Dear Abdulsamad Panchbhaya:
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 801); medical device reporting (reporting of medical
8
Page 2 - Abdulsamad Panchbhaya
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/forYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Indications for Use
510(k) Number (if known): K130788
Device Name: Capella Dynamic Tilt and Capella 45
Indications For Use:
The Future Mobility Healthcare Inc. Capella wheelchair is intended to provide mobility to persons limited to a sitting position.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use × (21 CFR 807 Subpart C)
(Please do not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Joyce M. Whang -S
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