(43 days)
Not Found
No
The device description and performance studies focus on the mechanical aspects and usability of a standard folding wheelchair, with no mention of AI or ML technology.
Yes
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position, which qualifies it as a therapeutic device.
No
Explanation: The device description clearly states it is a "Folding Manual Wheelchair" intended for "mobility to persons restricted to a sitting position." There is no mention of diagnostic functions, image processing, or AI/ML for analysis, which are typically associated with diagnostic devices.
No
The device description clearly outlines a physical, mechanical device (a wheelchair) with various hardware components. There is no mention of software as the primary or sole component.
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 restricted to a sitting position." This is a physical function, not a diagnostic test performed on samples taken from the human body.
- Device Description: The description details a mechanical device (a wheelchair) designed for physical support and mobility. It does not involve any reagents, instruments, or procedures for examining specimens.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Using laboratory equipment or procedures
In summary, the Breezy Elegance Folding Manual Wheelchair is a medical device for mobility assistance, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Breezy Elegance Folding Manual Wheelchairs are manually operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position.
Product codes
IOR
Device Description
The product offering consists of a standard folding aluminum wheelchair. (Standard in the sense that it is not built to a specific order, rather it will be built to inventory.)
The wheelchairs are
- User-propelled, as such, chair has 24" wheels with attached handrims - Foldable (using a cross-brace design) for easier transport and stowage
The device comprises - Cross-braced folding frame
- Quick-release Axle
- Large rear wheels with handrims for self-propulsion
- Smaller front wheels on casters for stability
- Padded seat sling material designed to support a seat cushion and to fold when the wheelchair frame is folded
- An upholstered backrest designed to fold when the wheelchair frame is folded, pre-set angle to 8
- Push handles at top of backrest to allow attendant to aid mobility of rider
- Swing-away armrests and swing-in/swing-out legrests (with footplates)
Available Options
Elevating legrest
Anti-tip Tubes
Technological characteristics
Aluminum frame to reduce weight and provide durability
Triple cross-brace for easy folding
Swing-away arm and leg rests for easier entry, egress, or transfer
Seat and back slings to accommodate separate cushion system for rider comfort and ease of folding
Tension adjustable back straps for user comfort
Optional on Models B & C
Drum brake system to aid attendant to control chair movement
Height adjustable push handles for attendant comfort
Height adjustable armrests for user comfort
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)
Bench Tests: Not Found
Design Verification: Design Control requirements per 21 CFR 820.30; testing/demonstration that all essential specifications show equivalent performance to recognized wheelchair standards or to the predicate device (Quickie Q2 Lite).
Design Validation: Third-party evaluation of chair performance, human factors, and usability demonstrate the fitness of the design to meet the requirements and demands of its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3850 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
improving people's lives
Image /page/0/Picture/1 description: The image shows the logo for Sunrise Medical. The logo consists of a stylized image of a sunrise on the left, with the word "SUNRISE" in large, bold letters to the right. Below "SUNRISE" is the word "MEDICAL" in smaller, bold letters. The logo is simple and professional, and the use of the sunrise image suggests themes of hope, new beginnings, and health.
K133855
510(k) Summary
JAN 3 1 2014
| Device | Breezy Elegance Manual Folding Wheelchair | |
|---|---|---|
| Owner | Sunrise Medical (US) LLC | |
| 2842 Business Park Avenue | ||
| Fresno, CA 93727 | ||
| Phone: 559-348-2572 | ||
| Fax: 559-294-2872 | ||
| Contact | Laurie H. Roberts | |
| Senior Manager-Regulatory Affairs | ||
| Date | 17 December 2013 | |
| Subject | ||
| Device | Trade name | Breezy Elegance |
| Common name | Manual Folding Wheelchair | |
| Regulation | 21 CFR 890.3850 | |
| Device name | Mechanical wheelchair | |
| Product code | IOR | |
| Device class | 1 | |
| Panel | Physical Medicine | |
| Predicate | Trade name | Quickie Q2 Lite |
| Manufacturer | Sunrise Medical (US) LLC | |
| Market Clearance | 510(k): K072153 (10 Sep 07) |
Device Description
Device purpose
・・・・・・・・・・・・
The product offering consists of a standard folding aluminum wheelchair. (Standard in the sense that it is not built to a specific order, rather it will be built to inventory.)
Device components
- The wheelchairs are
- User-propelled, as such, chair has 24" wheels with attached handrims - Foldable (using a cross-brace design) for easier transport and stowage
Continued on next page
2842 Business Park Avenue · Fresno, CA 93727-1328 · USA
800.333.4000
1
510(k) Summary: Breezy Elegance Wheelchair
| Device
components
(continued) | · The device comprises
- Cross-braced folding frame
- Quick-release Axle
- Large rear wheels with handrims for self-propulsion
- Smaller front wheels on casters for stability
- Padded seat sling material designed to support a seat cushion and to fold
when the wheelchair frame is folded - An upholstered backrest designed to fold when the wheelchair frame is
folded, pre-set angle to 8 - Push handles at top of backrest to allow attendant to aid mobility of rider
- Swing-away armrests and swing-in/swing-out legrests (with footplates)
· Available Options
Elevating legrest
Anti-tip Tubes | |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Technological
character-
istics | Aluminum frame to reduce weight and provide durability
Triple cross-brace for easy folding
Swing-away arm and leg rests for easier entry, egress, or transfer
Seat and back slings to accommodate separate cushion system for
rider comfort and ease of folding
Tension adjustable back straps for user comfort
Optional on Models B & C
●
Drum brake system to aid attendant to control chair movement
Height adjustable push handles for attendant comfort
Height adjustable armrests for user comfort | |
Intended Use
Breezy Elegance Folding Manual Wheelchairs are manually operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position.
Equivalence
The Breezy Elegance Wheelchair is substantially equivalent to its predicate device, Quickie Q2 Lite, based on intended use, materials, operating principle, technology, safety, and performance.
Breezy Elegance equivalence to Quickie Q2 Lite
Intended Use Identical: Provides mobility to persons restricted to a sitting position
2
510(k) Summary: Breezy Elegance Wheelchair
| Materials | Substantially equivalent:
Aluminum frame, support members, wheels, and components Steel fasteners and components Flexible polymeric tires Fabric covered foam upholstery Fabric straps and slings |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating
principle | Identical:
User propelled by hand pressure against handrims attached to large (24 inch) wheels Wheel locks to hold chair on slight slopes Quick release wheel hubs for easy removal of wheel for transport and storage Cross-braced, hinged frame for folding of chair for transport and storage Seat cushion and back upholstery for user comfort Adjustable, swing-away legrests with angle-adjustable footrests Push handles to allow assistance by an attendant |
| Energy
source | Identical: User propelled |
| Technology | Identical: Standard mechanical wheelchair construction and operation. |
| Safety and
performance | Substantially equivalent:
Accomplishes the same performance in the same way as the predicate with slightly more weight and weight carrying capacity Design raises no new issues of safety or effectiveness |
| Bench Tests | |
| Design
Verification | Design Control requirements per 21 CFR 820.30; testing/demonstration that
all essential specifications show equivalent performance to recognized
wheelchair standards or to the predicate device (Quickie Q2 Lite). |
| Design
Validation | Third-party evaluation of chair performance, human factors, and usability
demonstrate the fitness of the design to meet the requirements and demands
of its intended use. |
.
3
510(k) Summary: Breezy Elegance Wheelchair
Biocompatibility
| Type of
Contact | • Momentary contact with uncompromised skin of hands—various parts
• Transient contact with uncompromised skin of hands—handrims
• Transient contact with uncompromised skin of arms—armrests |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Evaluation | • Momentary contact of intact skin of hands on aluminum, steel, nylon fabric,
hard/soft plastics do not raise biocompatibility issues
• Handrim and armrest materials are identical with the predicate device and,
thus, raise no biocompatibility issue |
Packaging / Shelf life
Based on the durability, materials, and use of wheelchairs, packaging and shelf life are not relevant to the safe and effective use of these devices.
Conclusion
Breezy Elegance Manual Folding Wheelchairs are substantially equivalent to their predicate devices in technology, performance, and intended use. There are no significant differences between Breezy Elegance Wheelchairs and the Quickie Q2 Lite Wheelchair predicates in design which would raise new issues of safety and effectiveness, performance, function or intended use of the device. In addition, the chair design has been shown to be safe and effective for its intended uses.
4
Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
January 31, 2014
Sunrise Medical (US) LLC c/o Laurie H. Roberts 2842 Business Park Ave. Fresno, CA 93727
Re: K133855
Trade/Device Name: Breezy Elegance Folding Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: January 2, 2014 Received: January 2, 2014
Dear Ms. Roberts:
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
5
Page 2 - Ms. Laurie H. Roberts
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/ResourcesforYou/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/MedicalDeyjces/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,
Carlos L. Pena -S
Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ... ... . ....
Indications for Use
510(k) Number (if known) K133855
Device Name
Breezy Elegance Folding Manual Wheelchair
Indications for Use (Describe)
Breezy Elegance Folding Manual Wheelchairs are manually operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
区 Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Carlos L. Pena -S
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
7
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