(46 days)
Sunrise Medical Quickie 2 HP wheelchair
Not Found
No
The 510(k) summary describes a manual wheelchair and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as information typically associated with AI/ML device submissions (training/test sets, performance metrics like AUC, sensitivity, specificity).
No
The device is described as a wheelchair that aids mobility impaired individuals, similar to a predicate wheelchair. Its function is to facilitate movement for people with various conditions, not to treat or cure these conditions.
No
The device, a wheelchair, is intended to aid mobility for individuals with various conditions, not to diagnose those conditions. Its function is to facilitate movement, similar to the predicate device, the Sunrise Medical Quickie 2 HP wheelchair.
No
The device description and intended use clearly describe a physical wheelchair, which is a hardware device, not software.
Based on the provided information, the EZ Chair is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- EZ Chair's Intended Use: The EZ Chair is described as a wheeled device (wheelchair) used to aid mobility-impaired individuals. It is a physical device for transportation and support, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, laboratory procedures, or diagnostic purposes related to bodily fluids or tissues.
Therefore, the EZ Chair falls under the category of a medical device (specifically, a mobility aid), but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EZ Chair will be used, like a Sunrise Medical Quickie 2 HP wheelchair in the Hemi Height position, to aid the temporarily or permanently mobility impaired individual to move about indoors, and outdoors, through the use of a wheeled device (wheelchair). You can propel yourself by pushing along the ground with your feet or you can propel yourself by pushing the pedals. Like a Hemi Height chair, the EZ Chair will be used by people with limited use of their legs due to conditions such as: Arthritis, Single leg Amputee, Multiple Sclerosis, Muscular Dystrophy, Hemiplegic, Parkinson's Disease, Emphysema, Geriatric, Cerebral Palsy, Head Injury, Post Polio, etc.
Product codes
IOR
Device Description
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Sunrise Medical Quickie 2 HP wheelchair
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
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 1999
Mr. Chris Berryhill Vice President Premier Designs 4834 West Jacquelyn, Suite 101 Fresno, California 93722
K993298 Re: EZ Chair Trade Name: Regulatory Class: I Product Code: IOR Dated: September 28, 1999 Received: October 1, 1999
Dear Mr. Berryhill:
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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಗಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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.
1
Page 2 - Mr. Chris Berryhill
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 general 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.gov/cdrh/dsmamain.html".
Sincerely yours,
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
of Page
510 (k) NUMBER (IF KNOWN) : K993298
DEVICE NAME: EZ CHAIR
INDICATIONS FOR USE :
The EZ Chair will be used, like a Sunrise Medical Quickie 2 HP wheelchair in the Hemi Height position, to aid the temporarily or permanently mobility impaired individual to move about indoors, and outdoors, through the use of a wheeled device (wheelchair). You can propel yourself by pushing along the ground with your feet or you can propel yourself by pushing the pedals. Like a Hemi Height chair, the EZ Chair will be used by people with limited use of their legs due to conditions such as: Arthritis, Single leg Amputee, Multiple Sclerosis, Muscular Dystrophy, Hemiplegic, Parkinson's Disease, Emphysema, Geriatric, Cerebral Palsy, Head Injury, Post Polio, etc.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | |
|---|---|
| Over-The-Counter-Use X | |
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K993298 |
|---|---|
| --------------- | --------- |