(134 days)
Not Found
No
The description mentions a "microprocessor control unit" and a "joystick," which are standard components of powered wheelchairs and do not inherently indicate AI/ML. There is no mention of AI, ML, or related concepts in the text.
No
A therapeutic device is used to treat, cure, mitigate, or prevent a disease or condition. This device is a powered wheelchair that assists mobility, but it does not directly treat or cure any medical condition.
No
Explanation: The provided text describes the Bobcat DX as an electrically powered wheelchair designed to assist children with mobility, not to diagnose a condition. Its features enable movement, seating adjustments, and independence, all of which are functional, not diagnostic.
No
The device description clearly outlines physical components such as a chassis, fiberglass body, electric power, joystick, and elevating seat, indicating it is a hardware device with integrated software for control.
Based on the provided information, the Bobcat DX is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Bobcat DX is an electrically powered wheelchair designed for mobility and positioning. It does not interact with or analyze any biological samples.
- The intended use and device description clearly define the Bobcat DX as a mobility aid. Its purpose is to provide independent movement and adjustable seating/standing for children.
- There is no mention of any diagnostic or analytical function. The device's components and features are all related to its function as a wheelchair.
Therefore, the Bobcat DX 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 highly manoeuvrable Bobcat DX enables children to determine their own activities without asking or waiting for assistance. Simultaneous development, emotional and physical, with their able bodied peer group removes the inevitable frustration which would otherwise set in.
Dynamic DX control system allows a high level of control and manoeuvrability, allowing use within the home or school environment, indoors and outdoors. Elevator allows the user to adjust both sitting and standing heights enabling greater participation in activities.
Product codes (comma separated list FDA assigned to the subject device)
IPL
Device Description
Bobcat DX is highly manoeuvrable, electrically powered wheelchair. The unit consists of a front wheel drive chassis, enclosed in an attractive colourful fibreglass body, that is powered by a Control Dynamics DX microprocessor control unit. This control unit is controlled by a QED designed jovstick, which has very sensitive buttons with good tactile feedback. The Bobcat DX comes complete with an elevating seat that allows the child independently to lower themselves to the floor, or to raise themselves to table height. There are many seating options available and we also supply a standing frame.
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
children
Intended User / Care Setting
home or school environment, indoors and outdoors
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): 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.
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
§ 890.3900 Standup wheelchair.
(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows a logo or emblem with a stylized design. On the left, there is a large, circular shape that resembles a letter or symbol. To the right of this shape, there are the letters 'E' and 'D' separated by a dot. The overall design appears to be bold and graphic, with a focus on simplicity and clarity.
JUN 2 6 1997
Quest Enabling Designs Ltd Ability House 242 Gosport Road Fareham Hampshire (UK) POI6 OSS
Tel: +44 (0)1329 828444 Fax: +44 (0)1329 828800
Pre-market Notification Summary
New Device
| Trade Name: | Quest Enabling Designs Bobcat DX, powered wheelchair. |
|---|---|
| Common Name: | Powered wheelchair, with adjustable elevator. |
| Classification Name: | Physical Medicine, powered wheelchair. |
Predicate Legally Marketed Device (claiming equivalence to)
| 510(k) Number: | K942508. |
|---|---|
| Trade Name: | Permobil Chairman ROBO, powered wheelchair. |
| Common Name: | Powered wheelchair, with adjustable elevator. |
| Classification: | Physical Medicine. |
| Product Code: | INI. |
Description of New Device
Bobcat DX is highly manoeuvrable, electrically powered wheelchair. The unit consists of a front wheel drive chassis, enclosed in an attractive colourful fibreglass body, that is powered by a Control Dynamics DX microprocessor control unit. This control unit is controlled by a QED designed jovstick, which has very sensitive buttons with good tactile feedback. The Bobcat DX comes complete with an elevating seat that allows the child independently to lower themselves to the floor, or to raise themselves to table height. There are many seating options available and we also supply a standing frame.
Intended Use of New Device
The highly manoeuvrable Bobcat DX enables children to determine their own activities without asking or waiting for assistance. Simultaneous development, emotional and physical, with their able bodied peer group removes the inevitable frustration which would otherwise set in.
Dynamic DX control system allows a high level of control and manoeuvrability, allowing use within the home or school environment, indoors and outdoors. Elevator allows the user to adjust both sitting and standing heights enabling greater participation in activities.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 image of an eagle or bird with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Naheed Akhtar Quest Enabling Designs Limited ... Ability House, 242 Gosport Road JUN 2 6 1997 Fareham, Hampshire PO16 OSS
K970543 Re : Trade Name: Quest Enabling Designs Bobcat DX Requlatory Class: II Product Code: IPL Dated: April 7, 1997 Received: April 14, 1997
Dear Mr. Akhtar:
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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood 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. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will
2
Page 2 - Mr. Naheed Akhtar
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 requlations.
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 leqally 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 labelinq 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.gov/cdrh/dsmamain.html".
Sincerely yours,
Mark N. Millimson
1 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
Statements for Indications of Use.
Bobcat DX is highly manoeuvrable, electrically powered wheelchair. The unit consists of a front wheel drive chassis, enclosed in an attractive colourful fibreglass body, that is powered by a Control Dynamics DX microprocessor control unit. This controlled by a QED designed joystick, which has very sensitive buttons with good tactile feedback. The Bobcat DX comes complete with an elevating seat that allows the child independently to lower themselves to the floor, or to raise themselves to table height. There are many seating options available and we also supply a standing frame.
The child can easily adjust both sitting and standing heights, enabling participation at a table or bar for meals. Exclusion from normal eating areas and the necessity to have cumbersome trays or special furniture become things of the past. Playing on the floor and outdoors encourages independence for the child, leaving parents and carers free to continue with family socialising and household tasks, knowing that their child can move freely at will. With most activities pressure to assist is reduced merely to supervising normal play and development.
The highly manoeuvrable Bobcat DX enables children to determine their own activities without asking or waiting for assistance. Simultaneous development, emotional and physical, with their able bodied peer group removes the inevitable frustration which would otherwise set in.
Transporting the Bobcat DX presents no difficulty with the easily removable seat, remote drive panel and compact size of the unit.
Benefits include:
- QED offers a wide range of seating options. .
- · Dynamic DX control system enables the Bobcat DX to be used successfully within the school, home or outdoor.
- Three dimensional movement reduces the need for carer participation in many activities. .
- . Easy 'break-down' for transport in the back of estate car,
- . Accessories available including trays, lights and indicators and ramps.
- Suitable for users up to 12 stone (75kg) in weight. .
t.
Man n Miller
(Division Sign-Off) for (mw
Division of General Restorative Devices
Over-the-Counter Use X