(46 days)
Not Found
No
The description details a purely mechanical wheelchair with no mention of AI or ML components.
No
The device is a manual wheelchair providing mobility, not a therapeutic intervention for a medical condition.
No
Explanation: The device described is a manual wheelchair, which is a mobility aid, not a diagnostic device. Its intended use is to provide mobility, and the testing mentioned relates to structural integrity and safety standards, not diagnosis.
No
The device description clearly outlines a physical, mechanical wheelchair with components like a frame, upholstery, wheels, and casters. It is not software-only.
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 limited to a seated position." This is a mechanical function related to physical support and movement, not the diagnosis of disease or other conditions through the examination of specimens derived from the human body.
- Device Description: The description details a mechanical wheelchair with components like a frame, upholstery, wheels, and casters. There is no mention of any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnostic purposes
- Use in a laboratory setting
The device is clearly a mobility aid, falling under the category of medical devices that provide physical support and assistance.
N/A
Intended Use / Indications for Use
To provide mobility to persons limited to a seated position.
Product codes
IOR
Device Description
The Kuschall Design K3/K4 series of manual wheelchairs are lightweight wheelchairs that provide mobility to persons limited to a sitting position. They consist of a rigid, mechanical, aluminum frame and a coated nylon upholstery that meets EN1021-1; Assessment of the Ignitability of Upholstered Furniture. They have larger rear wheels with handrims for pushing and steering. They have smaller front casters for turning and maneuverability. Different front casters are available. The K3 has 3 wheels, 2 large rear wheels and 1 front caster. The K4 has 4 wheels, 2 large rear wheels and 2 front casters.
The Kuschall Design K3/K4 series is available in various seat width's, depths, and heights and has an adjustable seat angle and tip stability. The camber is also adjustable to various increments.
They are sporty looking chairs with a more high performance feel that the standard version wheelchair. They are intended for the more active user.
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)
The Kuschall Design K3/K4 series was tested by TUV Product Service to the following standards and met all the requirements:
- DIN EN 12182 (2/96) Manually Propelled Wheelchair Requirements and Test Methods
- DIN ISO 7176 Part 8 (1992) Wheelchairs Part 8: Requirements and Test . Methods for Static, Impact and Fatigue Strengths
- EN 1021-1 Furniture Assessment of the Ignitability of Upholstered Furniture .
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
982336
510(k) SUMMARY
AUG 21 1998
Invacare Corporation Kuschall Design AG K3/K4 series of manual wheelchairs
Submitter's Name, Address, Telephone Number, Contact Person and, Date Prepared.
Invacare Corporation One Invacare Way PO Box 4028 Elyria, Ohio 44036 Phone: (440) 329-6595 Facsimile: (440) 365-4558
Edward A. Kroll Contact Person: Director, TQM and Regulatory Affairs
June 26, 1998 Date Prepared:
Name of Device and Name/Address of Sponsor
Kuschall Design K3/K4 series of manual wheelchairs
Invacare Corporation One Invacare Way Elyria, Ohio 44036-2028 Phone: (440) 329-6000 Facsimile: (440) 365-4558
Name and Address of Manufacturer
Kuschall Design AG Ringstrasse 15 4123 Allschwill Switzerland Phone: 011-41-61-61-5666 Facsimile: 011-41-61-481-5240
Common or Usual Name
Manual Wheelchair
Classification Name
Wheelchair, Mechanical
1
Predicate Devices
The Kuschall Design K3/K4 series of manual wheelchairs are substantially equivalent to The Invacare Action Pro T Manual Wheelchairs (K914553, 10/9/91).
Intended Use
The intended use of Kuschall Design K3/K4 series of manual wheelchairs is to provide mobility to persons limited to a sitting position.
Technological Characteristics and Substantial Equivalence
A. Device Description
The Kuschall Design K3/K4 series of manual wheelchairs are lightweight wheelchairs that provide mobility to persons limited to a sitting position. They consist of a rigid, mechanical, aluminum frame and a coated nylon upholstery that meets EN1021-1; Assessment of the Ignitability of Upholstered Furniture. They have larger rear wheels with handrims for pushing and steering. They have smaller front casters for turning and maneuverability. Different front casters are available. The K3 has 3 wheels, 2 large rear wheels and 1 front caster. The K4 has 4 wheels, 2 large rear wheels and 2 front casters.
The Kuschall Design K3/K4 series is available in various seat width's, depths, and heights and has an adjustable seat angle and tip stability. The camber is also adjustable to various increments.
They are sporty looking chairs with a more high performance feel that the standard version wheelchair. They are intended for the more active user.
B. Substantial Equivalence
The Kuschall Design K3/K4 series of manual wheelchairs are substantially equivalent to the Action Pro and Pro T Manual Wheelchairs (K914553, 10/9/91).
Each of these products are lightweight manual wheelchairs with the intended use of providing mobility to a person limited to a seated position. They are rigid frames with foldable backs and adjustable seat angle, tip stability and camber.
PERFORMANCE DATA
The Kuschall Design K3/K4 series was tested by TUV Product Service to the following standards and met all the requirements:
- · DIN EN 12182 (2/96) Manually Propelled Wheelchair Requirements and Test Methods
- DIN ISO 7176 Part 8 (1992) Wheelchairs Part 8: Requirements and Test . Methods for Static, Impact and Fatigue Strengths
- EN 1021-1 Furniture Assessment of the Ignitability of Upholstered Furniture .
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 21 1998
Mr. Edward A. Kroll Director, TQM and Regulatory Affairs Invacare Corporation One Invacare Way P.O. Box 4028 Elyria, Ohio 44036-2125
K982336 Re: Kuschall Design K3/K4 Series of Manual Wheelchairs Regulatory Class: I Product Code: IOR Dated: June 26, 1998 Received: July 6, 1998
Dear Mr. Kroll:
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, 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. ಗ್ರಾಮ 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 requlation (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.
3
Page 2 - Mr. Edward A. Kroll
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,
Mark N. Millikinson
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
4
70(k) Number (if known): TBD
Device Name: Kuschall Design K3/K4 series of manual wheelchairs
Indications For Use: To provide mobility to persons limited to a seated position.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of De
Mark-N-Mellerson
fon (Division Sign-Oft)
cmin Division of General Restorative Devices
510(k) Number K982336
Prescription Use Per 21 CFR 801.109)
OR
Over-The-Counter Us
(Optional Format 1-2-96)