(29 days)
Not Found
No
The device description and intended use describe a standard manual wheelchair with no mention of AI or ML technology.
No
The device description and intended use indicate it is a manual transport device (a wheelchair) for mobility, which does not inherently qualify it as a therapeutic device.
No
Explanation: The device described is a manual wheelchair, which is used for transportation and mobility, not for diagnosing medical conditions.
No
The device description clearly outlines a physical, manual wheelchair with various hardware components (wheels, frame, armrests, etc.). There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. They are used outside of the body (in vitro) to diagnose, monitor, or screen for diseases or conditions.
- Device Description: The description clearly states that this is a manual transport device used to maneuver a seated individual. It is a physical device for mobility and patient transfer.
- Intended Use: The intended use is to propel or push the chair to move a seated individual and to lock the wheels for patient transfer. This is a mechanical function, not a diagnostic test performed on a biological sample.
The information provided describes a standard manual wheelchair, which is a mobility aid, not an IVD.
N/A
Intended Use / Indications for Use
Predicate manual wheelchair use is stated to allow user, or user assistant to propel or push chair in order to maneuver seated individual in a safe, controlled environment. Also must be able to lock rear wheels for patient transfer. Subject wheelchair is to have same functionality.
Product codes
IOR
Device Description
Wheelchair to be a manual transport device, with 8" fron swivel casters on the front, and 24" mag style wheels on the rear. Wheelchair will be foldable for storage, will be chrom- plate Finnish. Armrests will be padded or plastic and wil have padded embossed upholstery for user comfort. Wheelchair will be equipped with wheel locks to prevent rolling while transferring patient. Push handles will be of a non-slip vinyl material. Standard color available will be dark blue. Chairs to have rear extensions to prevent tip-over. Wheelchairs to be available in models with swing away footrests or elevating legrests as shown in pictures.
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)
Not Found
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 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
Assembly Required Distributors Inc.
3 Crabapple Lane Commack, NY 11725-2405 Phone/fax 516-864-9575
14973418
September
September 5, 1997
510K Summary
-7 -
| Submitter: | Assembly Required Distributors Inc.
3 Crabapple Lane
Commack, NY 11725
516-864-9575 |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Doreen Murphy |
| Date of Preparation: | 9/8/97 |
| Trade/Proprietary Name: | Transport Plus and Transport Deluxe |
| Common/Usual Name: | Manually Propelled Transport Wheelchair |
| Legally Marketed Device:
For Equivalence | Everest & Jennings model Universal wheelchair – K930411
Invacare model Rolls 2000 wheelchair - K881762 |
| Device Description: | Wheelchair to be a manual transport device, with 8" fron
swivel casters on the front, and 24" mag style wheels on the
rear. Wheelchair will be foldable for storage, will be chrom-
plate Finnish. Armrests will be padded or plastic and wil
have padded embossed upholstery for user comfort.
Wheelchair will be equipped with wheel locks to prevent
rolling while transferring patient. Push handles will be of a
non-slip vinyl material. Standard color available will be dark
blue. Chairs to have rear extensions to prevent tip-over.
Wheelchairs to be available in models with swing away
footrests or elevating legrests as shown in pictures. |
| Intended Use: | Predicate manual wheelchair use is stated to allow user, or
user assistant to propel or push chair in order to maneuver
seated individual in a safe, controlled environment. Also
must be able to lock rear wheels for patient transfer. Subject
wheelchair is to have same functionality. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, composed of three overlapping lines that suggest a face and neck. The figure is oriented to the right. Encircling the figure is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 9 1997
Ms. Doreen Murphy Compliance Officer Assembly Required Distributors, Inc. 3 Crabapple Lane Commack, New York 11725-2405
K973418 Re: Transport Plus and Transport Deluxe Trade Name: Requlatory Class: I Product Code: IOR September 8, 1997 Dated: Received: September 10, 1997
Dear Ms. Murphy:
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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 In addition, FDA may publish further announcements action. 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 requlations.
2
Page 2 - Ms. Doreen Murphy
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 ene regaracion enereroa, "hibbianany "}} 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,
Celia M. Witten, Ph.D., M.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Assembly Required Distributors Inc.
3 Crabapple Lane Commack, NY 11725-2405 Phone/fax 516-864-9575
September 5, 1997
Intended Use:
Predicate manual wheelchair use is stated to allow user, or user assistant to propel or push chair in order to maneuver seated individual in a safe, controlled environment. Also must be able to lock rear wheels for patient transfer. Subject wheelchair is to have same functionality.
Acoello
Over-the-Counter Use X