(9 days)
Not Found
Not Found
No
The description focuses on mechanical adjustments and features of a manual wheelchair, with no mention of AI or ML technology.
No.
The device is described as a manual wheelchair intended to provide mobility, but it is not intended to treat, cure, or prevent any disease or condition, which would make it a therapeutic device.
No
The device is a manual wheelchair, described for providing mobility to physically challenged persons. Its primary function is to facilitate movement, not to diagnose medical conditions.
No
The device description clearly describes a physical manual wheelchair with mechanical components (seat, back, frame) and mentions testing to physical wheelchair standards (ISO7176, ANSI/RESNA). There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this is a manual wheelchair designed to provide mobility for physically challenged individuals. It focuses on mechanical features, adjustability, and comfort for the user.
- Intended Use: The intended use is to empower physically challenged persons by providing a means of mobility. This is a physical aid, not a diagnostic tool.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
The device is a mobility aid, not a diagnostic device.
N/A
Intended Use / Indications for Use
Quickie manual wheelchairs empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions in all ages suc as:
Arthritis Amputee Paraplegic Cerebral Palsy Hemiplegic
Tetraplegic Quadriplegic Spina Bifida Head Injury or Trauma Muscular Dystrophy_
Multiple Sclerosis Polio Geriatric conditions And other immobilizeing or debilitating conditions
A wheelchair with Bus Transport Option may be used for motor vehicle transportatio with the use of wheelchair tie down and occupant restraint system (WTORS) that me the requirements of SAE J2249
Product codes (comma separated list FDA assigned to the subject device)
IOR
Device Description
Zippie GS wheelchairs are light weight, low maintenance, manual chairs, which are intended to provide mobility based on an individual users' needs and capabilities. They are available in a range of sizes (dimensions) to allow fit to a particular user.
The key change covered by this submission is the addition of optional growing solid seat and growing adjustable back. Individuals who use these wheelchairs benefit from the use of different seat cushions and back shapes as required by their individual postures and level of disability.
The addition of an optional growing solid seat facilitates the use of various cushions. The seat has been designed to offer a low cost support for these cushions. By being able to "grow" with the frame as it is adjusted in width and depth to accommodate change in the client's posture, dimensions or condition, the cost of these changes is reduced.
The addition of an optional growing adjustable back upholstery provides users the ability to adjust the contours of the upholstery by adjusting the length of individual straps at various contact points on the trunk. The back is also adjustable in height to match the height of various clients and their need for various degrees of posterior trunk support. The individuals straps also allow for adjustment of the depth of contour or "hammocking" of the back. This allows the client to adjust for lateral support of the trunk. The back has been designed to offer a low cost means for the adjustment of the aforementioned supporting shapes. Additionally by being able to "grow" with the frame as it is adjusted in width to accommodate change in the client's width, the cost of these changes is reduced.
When couple with the adjustment of the following performance factors the users function and comfort can be enhanced.
Zippie GS wheelchairs consist of typical components found on most wheelchairs, such as backrest, seat frame, cushion, footrest and casters. Options include growing solid seat and growing adjustable back. Accessories include items such as elevating leg rest, armrests, positioning belts, backpacks, seat pouches, oxygen tank holders, IV poles, etc.
Many of these components may become available in a range of sizes, shapes, angles, forms, materials or coverings. These variations allow the chairs to be configured to meet the specific desires and needs of the user.
The optional growing solid seat and growing adjustable back is much like those used in competitive products.
The chairs have excellent performance indoors and are very good outdoors over surfaces that are firm and free of large obstacles and long steep inclines. That makes them an ideal maneuverable, light duty, light weight "Get out there chair".
The feature/option will be employed to upgrade the performance of existing devices manufactured by Sunrise Medical Mobility Products Division.
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
all ages
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)
This device has been tested to both ISO7176 and ANSVRESNA Wheelchair Standards. They include:
Determination of Static Stability - Pass
Overall Dimensions, Mass and Turning Space - Pass
Seating Dimensions - Pass
Static Impact and Fatigue Strength - Pass
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.
Not Found
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.
Not Found
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
§ 890.3850 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
510k Notification - Zippie GS with growing solid seat & growing adjustable back
13.0 510(k) SUMMARY OF SAFETY AND EFFICACY
Rebecca Andersen Submitter: Date: 10/14/98
OCT 26 1998
Name(s) of the device(s):
Zippie GS
Identification of predicate device(s):
- Quickie Kidz Zippie Zippie 2 Action Allegro Action Comet
Description of the device:
Zippie GS wheelchairs are light weight, low maintenance, manual chairs, which are intended to provide mobility based on an individual users' needs and capabilities. They are available in a range of sizes (dimensions) to allow fit to a particular user.
The key change covered by this submission is the addition of optional growing solid seat and growing adjustable back. Individuals who use these wheelchairs benefit from the use of different seat cushions and back shapes as required by their individual postures and level of disability.
The addition of an optional growing solid seat facilitates the use of various cushions. The seat has been designed to offer a low cost support for these cushions. By being able to "grow" with the frame as it is adjusted in width and depth to accommodate change in the client's posture, dimensions or condition, the cost of these changes is reduced.
The addition of an optional growing adjustable back upholstery provides users the ability to adjust the contours of the upholstery by adjusting the length of individual straps at various contact points on the trunk. The back is also adjustable in height to match the height of various clients and their need for various degrees of posterior trunk support. The individuals straps also allow for adjustment of the depth of contour or "hammocking" of the back. This allows the client to adjust for lateral support of the trunk. The back has been designed to offer a low cost means for the adjustment of the aforementioned supporting shapes. Additionally by being able to "grow" with the frame as it is adjusted in width to accommodate change in the client's width, the cost of these changes is reduced.
When couple with the adjustment of the following performance factors the users function and comfort can be enhanced.
1
PERFORMANCE FACTORS
The impact of each adjustment has a different performance implication for the rider.
| Camber | Camber adjustments range from 0 to 6 degrees |
|---|---|
| Wheel position | Rear wheels are set back to increase the wheelchair base. This improves stability. |
| Wheelchairs may be susceptible to tipping over backwards. Sunrise recommends | |
| the use of anti tip tubes. | |
| Wheel Base | |
| orTrack Width | Currently adjustable over a 4 inch range, a wider wheel base increases stability. |
| Width can be adjusted to weigh gain or other environmental changes to allow | |
| enough space between the rider and the wheel. | |
| Caster height. | Caster fork allows adjustments to be made ranging from +/-1 inch |
| Back Rest Angle | Adjustable from 78 degrees to 120 degrees. |
| This angle is adjusted for need or comfort. | |
| Seat Angle or | |
| Squeeze | Adjustable squeeze from 0 - 2 inches |
| Center of Gravity | The balance point. Different for each individual occupying a chair. This |
| adjustment is made by the rider to his personal sense of balance, and reactivity. | |
| Center of gravity is adjusted by changes to axle position, seat angle, seat depth |
These factors are interrelated and must be adjusted to complement each other to tune the chair performance.
(weight distribution) and backrest angle
These adjustments are routinely made today, and usually require disassembly and the exchange of one part for another with different dimensions or geometry.
The predicate devices including the existing Zippie & Quickie product lines allow users to make adjustments to these factors as well as the wheelchairs seat and back support surfaces.
Chairs are configured to customer orders when sold. Configuration to order allows flexibility. Features such as width, depth, and back height are specified and may range from 10 to 18 inches. Specific configuration includes chair accessories and desired use or safety features. Any combination of features from the approved matrix may be configured to create the chair features needed by a given rider II is the rider and the health care professional that determine the appropriate configuration for the users needs. As the individuals condition or size change, other components or accessories may be ordered and the chair reconfigured to meet the evolving needs of its user.
2
: ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Zippie GS wheelchairs consist of typical components found on most wheelchairs, such as backrest, seat frame, cushion, footrest and casters. Options include growing solid seat and growing adjustable back. Accessories include items such as elevating leg rest, armrests, positioning belts, backpacks, seat pouches, oxygen tank holders, IV poles, etc.
Many of these components may become available in a range of sizes, shapes, angles, forms, materials or coverings. These variations allow the chairs to be configured to meet the specific desires and needs of the user.
The optional growing solid seat and growing adjustable back is much like those used in competitive products.
The chairs have excellent performance indoors and are very good outdoors over surfaces that are firm and free of large obstacles and long steep inclines. That makes them an ideal maneuverable, light duty, light weight "Get out there chair".
The feature/option will be employed to upgrade the performance of existing devices manufactured by Sunrise Medical Mobility Products Division.
COMPARISON OF DEVICE CHARACTERISTICS TO PREDICATE(S):
Testing:
This device has been tested to both ISO7176 and ANSVRESNA Wheelchair Standards. They include:
| Determination of Static Stability | Pass |
|---|---|
| Overall Dimensions, Mass and Turning Space | Pass |
| Seating Dimensions | Pass |
| Static Impact and Fatigue Strength | Pass |
Safety:
An analysis of complaints against Quickie manual chairs was completed and charted. This analysis was supported by a literature search which was conducted by a third party to determine the number of complaints, MDR's and recalls that have been reported to the FDA concerning wheelchairs in general. This information was summarized, and presented in a Management Review report dated 2/20/97. The data and charts are included as Appendix C. The analysis demonstrated common issues across all manufacturers product lines, and varying levels approximately comparable to relative market share.
3
Efficacy
Articles are being provided on the use and efficacy of mechanical reclining wheelchairs. See Appendix C.
510(k) number:
Not assigned at the writing of this summary
Conclusion:
The Zippie GS Wheelchair model shares performance features and technology with a number of devices already legally marketed within the United States. The design changes that allow the user to adjust the back angle of the chair do not introduce issues of safety or efficacy. This feature introduces comfort and convenience. Therefore, the Breezy 510 Reclining wheelchair option is substantially equivalent to the predicate devices.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized lines representing the wings and a wavy line representing the body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 26 1998
Ms. Rebecca Andersen Vice President, Quality and Regulatory Affairs Sunrise Medical, Inc. 7477A East Dry Creek Parkway Lonqmont, Colorado 80503
Re: K983639 Zippie GS, Model #EIZGS Trade Name: Requlatory Class: I Product Code: IOR October 14, 1998 Dated: Received: October 16, 1998
Dear Ms. Andersen:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
5
Page 2 - Ms. Rebecca Andersen
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D.,
Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
THE ANDERESSION TAPPING AND WARD ..
12.2 Indications for Use
Intended use:
Quickie manual wheelchairs empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions in all ages suc as:
Arthritis Amputee Paraplegic Cerebral Palsy Hemiplegic
Tetraplegic Quadriplegic Spina Bifida Head Injury or Trauma Muscular Dystrophy_
Multiple Sclerosis Polio Geriatric conditions And other immobilizeing or debilitating conditions
A wheelchair with Bus Transport Option may be used for motor vehicle transportatio with the use of wheelchair tie down and occupant restraint system (WTORS) that me the requirements of SAE J2249
510(k) number: Not assigned as of this time
Device name: Zippie GS
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use (per 21 CFR801.109) #
Over-the-counter use
Over-the-Counter Use
Bially to
(Division Sign-Off) Division of General Restorative I 510(k) Number
Image /page/6/Picture/16 description: The image shows a black and white drawing of a round object. The object has a dark upper portion and a lighter lower portion. There are curved lines on the surface of the object, suggesting texture or patterns.
10/14/98 Sunrise Medical Inc., HHG, Mobility Products Division