Who is the manufacturer of CAPELLA?

Future Mobility Healthcare, Inc. filed the 510(k) submission for CAPELLA (K130788).

What is the FDA product code for CAPELLA?

IOR. It is classified under 21 CFR 890.3850 as a Class 1 device in the Physical Medicine panel.

What is the regulatory pathway for CAPELLA?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CAPELLA?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CAPELLA

K130788 · Future Mobility Healthcare, Inc. · IOR · Dec 5, 2013 · Physical Medicine

Device Facts

Record ID	K130788
Device Name	CAPELLA
Applicant	Future Mobility Healthcare, Inc.
Product Code	IOR · Physical Medicine
Decision Date	Dec 5, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 890.3850
Device Class	Class 1

Indications for Use

The Future Mobility Healthcare Inc. Capella wheelchair is intended to provide mobility to persons limited to a sitting position.

Device Story

Capella and Capella 45 are manual, tilt-in-space mechanical wheelchairs; designed for mobility of persons limited to sitting position. Device features rigid aluminum frame; anti-tippers; adjustable seat width/depth; arm heights; and front riggings. Tilting mechanism operated by caregiver via levers on push bars connected by cables to gas springs (one gas spring for Capella 45; two for Capella). Device supports human weight up to 350 lbs (Capella) or 250 lbs (Capella 45). Used in various environments for patient transport or self-propulsion. Benefits include body weight redistribution for optimal positioning and comfort. Safety features include spring-return push-to-lock wheel locks and anti-tipper fixtures.

Clinical Evidence

Bench testing only. Device evaluated for stability, fatigue, and strength per ANSI/RESNA WC/Vol.1 and ISO 7176 (parts 1, 5, 7, 8, 11, 13, and 15). Results were satisfactory and met all applicable standards.

Technological Characteristics

Rigid aluminum frame; manual tilt-in-space mechanism using gas springs (one or two depending on model); adjustable dimensions (seat width/depth, arm height, back post height); anti-tippers; spring-return push-to-lock wheel locks. Materials meet California Technical Bulletin CAL 177 for flame retardancy. Tested to ANSI/RESNA WC/Vol.1 and ISO 7176 standards.

Indications for Use

Indicated for persons limited to a sitting position requiring a manual wheelchair for mobility. No specific age or gender restrictions; intended for over-the-counter use.

Regulatory Classification

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.

Predicate Devices

PDG Inc. Fuze T20 (K063736)

Submission Summary (Full Text)

{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 Page 1 of _ 1

CAPELLA

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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