(15 days)
Not Found
No
The device description focuses on mechanical and electrical components, maneuverability, comfort features, and modular design. There is no mention of any software features that would suggest the use of AI or ML for control, navigation, or other functions.
Yes
The wheelchair is used to provide mobility to individuals whose ability to walk is restricted due to various medical conditions like paralysis, loss of limbs, or other illnesses, making it a device that provides therapy by alleviating a physical impairment.
No
Explanation: The device described is a wheelchair, which is a mobility aid. Its intended use is to provide mobility to individuals with limited walking ability, not to diagnose medical conditions.
No
The device description clearly details a physical wheelchair with numerous hardware components, including chassis, wheels, suspension, batteries, and electronic components housed in a protective casing. While it mentions a control panel and adjustable driving parameters, the core of the device is a physical mobility aid, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device is a powered wheelchair. Its purpose is to provide mobility to individuals with limited walking ability. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states that the wheelchair provides mobility to persons limited to a sitting position. It does not mention any diagnostic purpose.
Therefore, the Adventure A10 wheelchair falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A wheelchair can be provided as a result of medical indication where walking is no longer possible or the ability to walk is severely restricted through:
- paralysis ●
- . loss of a limb or limbs
- . defects/deformation of a limb or limbs
- . contractures of the joints
- . other illnesses
The intended use of the wheelchair is to provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair
Product codes
ITI
Device Description
The Adventure A10 wheelchair is a lightweight wheelchair with full spring suspension and extremely good outdoor driving characteristics which can also be used indoors without any problems, due to its maneuverability.
All components are made of non-corrosive materials or have an anti-corrosive surface.
The housing for electronic components and all plug connections fulfill the IPX4 degree of protection. The permitted operating temperature lies between -25°C and +50°C.
In addition to the comfort offered on normal asphalted streets, roads and paths, the A10 also offers a high degree of driving comfort on cobbled streets and, in particular, on field and forest paths and on level meadows. This is realized through its chassis with full spring suspension, longitudinal steering wheels and individual wheel suspension elements. Spring travel is 52 mm.
Obstacles up to a height of 120 mm can be negotiated with the aid of a curb climber included in the accessories.
The tires are designed to achieve good rolling characteristics and noise-free operation on smooth surfaces, both indoors and outdoors. The integrated cleat tread provides the required traction in off-road use.
The tilt supports secure the vehicle against tilting backwards when negotiating obstacles and slopes. The Adventure can be raised on the drive wheels with the integrated jack-up mechanism to facilitate their removable and refitting.
The Adventure can be rapidly and simply dismantled into 8 individual components without tools or aids, thanks to the modular construction. Contact is established automatically during this with the drives and battery packs.
The modular construction of the Adventure means it can also be transported easily in smaller vehicles. Defective components can be replaced quickly in the event of a breakdown, meaning that long periods of disuse are avoided and there is no longer any need to send the entire wheelchair in for repairs.
The logical lightweight construction means that the max, empty weight is 96.7 kg (without accessories). The weight of individual removable components is derived as follows:
The seat unit weighs 14.3 kg, the chassis weighs 26.2 kg, and each wheel weighs 11.2 kg. The steering wheel weighs 2.3 kg each, and each battery pack weighs 14.6 kg.
The max. permissible occupant weight is 140 kg. The permissible overall weight is 255 kq. Slopes and gradients up to 18% and sloping ground up to 12% can be safely traversed, thanks to the optimally positioned center of gravity of the Adventure.
The compact dimensions of the Adventure, with an overall length of 1100 - 1300 mm (depending on the setting of the seat angle and leg supports), a max. width of 680 mm and a turning radius of 950mm enable its easily handling, even indoors. An option exists for switching the control on the control panel to indoor mode, enabling better control of the vehicle in confined spaces.
The removable seat is available in standard and function seat versions. The standard seat is equipped with washable, non-removable seat padding and has limited adjustment functions.
The function seat version is available with standard or comfort padding, each of which is removable and washable.
In contrast to the standard seat, the function seat has continuous adjusting options for both the back and leg supports. The seat width, depth and back height can also be varied.
The armrests are removable or can be simply pivoted to the rear (to facilitate movement of the occupant).
The Adventure is equipped with a parking brake which can be actuated by the driver. The Adventure can be pushed by an accompanying person when the parking brake is released and the system deactivated.
The various driving parameters which can be adapted to suit the occupant's disability can be edited directly on the control panel without an additional external programming unit.
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
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).
0
Ulrich Alber GmbH + Co. KG
Vor dem Weißen Stein 21
72461 Albstact
Tel.: 07432-2006-0
Fax: 07432-2006-299
510(k) summary
DOVENTUAG
Identification of Legally Marketed Devices:
| Ranger RWD | |
|---|---|
| 1. Applicant: | Invacare Corp. |
| 2. Manufacturer: | Invacare Corp. |
| 3. Device Name: | Ranger RWD |
| 4. 510(k)-Number | K993413 |
| 5. Decision Date: | 12/15/1999 |
Trax
| 1. Applicant: | Permobil A.B. |
|---|---|
| 2. Manufacturer: | Permobil A.B. |
| 3. Device Name: | Trax |
| 4. 510(k)-Number | K993413 |
| 5. Decision Date: | 12/18/2000 |
D. Description of the device
The Adventure A10 wheelchair is a lightweight wheelchair with full spring suspension and extremely good outdoor driving characteristics which can also be used indoors without any problems, due to its maneuverability.
All components are made of non-corrosive materials or have an anti-corrosive surface.
The housing for electronic components and all plug connections fulfill the IPX4 degree of protection. The permitted operating temperature lies between -25°C and +50°C.
In addition to the comfort offered on normal asphalted streets, roads and paths, the A10 also offers a high degree of driving comfort on cobbled streets and, in particular, on field and forest paths and on level meadows. This is realized through its chassis with full spring suspension, longitudinal steering wheels and individual wheel suspension elements. Spring travel is 52 mm.
1
Obstacles up to a height of 120 mm can be negotiated with the aid of a curb climber included in the accessories.
The tires are designed to achieve good rolling characteristics and noise-free operation on smooth surfaces, both indoors and outdoors. The integrated cleat tread provides the required traction in off-road use.
The tilt supports secure the vehicle against tilting backwards when negotiating obstacles and slopes. The Adventure can be raised on the drive wheels with the integrated jack-up mechanism to facilitate their removable and refitting.
The Adventure can be rapidly and simply dismantled into 8 individual components without tools or aids, thanks to the modular construction. Contact is established automatically during this with the drives and battery packs.
The modular construction of the Adventure means it can also be transported easily in smaller vehicles. Defective components can be replaced quickly in the event of a breakdown, meaning that long periods of disuse are avoided and there is no longer any need to send the entire wheelchair in for repairs.
The logical lightweight construction means that the max, empty weight is 96.7 kg (without accessories). The weight of individual removable components is derived as follows:
Image /page/1/Figure/9 description: The image shows an exploded view of a wheelchair and its components. The seat unit weighs 14.3 kg, the chassis weighs 26.2 kg, and each wheel weighs 11.2 kg. The steering wheel weighs 2.3 kg each, and each battery pack weighs 14.6 kg.
The max. permissible occupant weight is 140 kg. The permissible overall weight is 255 kq. Slopes and gradients up to 18% and sloping ground up to 12% can be safely traversed, thanks to the optimally positioned center of gravity of the Adventure.
2
The compact dimensions of the Adventure, with an overall length of 1100 - 1300 mm (depending on the setting of the seat angle and leg supports), a max. width of 680 mm and a turning radius of 950mm enable its easily handling, even indoors. An option exists for switching the control on the control panel to indoor mode, enabling better control of the vehicle in confined spaces.
The removable seat is available in standard and function seat versions. The standard seat is equipped with washable, non-removable seat padding and has limited adjustment functions.
The function seat version is available with standard or comfort padding, each of which is removable and washable.
In contrast to the standard seat, the function seat has continuous adjusting options for both the back and leg supports. The seat width, depth and back height can also be varied.
The armrests are removable or can be simply pivoted to the rear (to facilitate movement of the occupant).
The Adventure is equipped with a parking brake which can be actuated by the driver. The Adventure can be pushed by an accompanying person when the parking brake is released and the system deactivated.
The various driving parameters which can be adapted to suit the occupant's disability can be edited directly on the control panel without an additional external programming unit.
E. Intendend use statement
A wheelchair can be provided as a result of medical indication where walking is no longer possible or the ability to walk is severely restricted through:
- paralysis .
- loss of a limb or limbs .
- defects/deformation of a limb or limbs .
- . contractures of the joints
- . other illnesses
The intended use of the wheelchair is to provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair
3
F. Technological Characteristics summary
The Adventure is substantially equivalent to Invacare´s Ranger RWD, cleared on 12-15-1999 as K993413.
The Adventure is also substantially equivalent to Permobil´s Trax, cleared on 12-18-2000 as K993413.
Both substantially equivalent wheelchairs had to be tested on the same international standards for wheelchairs and both are listed by the FDA.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a black and white circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the edge. In the center of the seal is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 5 - 2004
Ulrich Alber GMBH c/o Mr. Stefan Preiss TUV America, Inc. 1775 Old Highway 8 New Brighton, Minnesota 55112
Re: K042535 Trade/Device Name: Adventure A10 Regulation Number: 21CFR 890. 3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: September 14, 2004 Received: September 20, 2004
Dear Mr. Preiss:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreatment date of the Medical Device Amendments, or to conninered pror to May 20, 1978, in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, diererere, mains of the Act include requirements for annual registration, listing of general controls profice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it rr your device is onaceaned (tional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r hat FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or carry with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
Page 2 - Mr. Stefan Preiss
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Melkerson
Celia M. Witten, Ph.D., M.D. Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K042535
Device Name: Adventure A10
Indications For Use:
A wheelchair can be provided as a result of medical indication where walking is no longer possible or the ability to walk is severely restricted through:
- paralysis ●
- . loss of a limb or limbs
- . defects/deformation of a limb or limbs
- . contractures of the joints
- . other illnesses
The intended use of the wheelchair is to provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A Melhum
al. Restorative. and Neurological Devices
Page 1 of
510(k) Number K042535