(14 days)
K 963817, K 031289
Not Found
No
The description focuses on mechanical and electrical components (motors, batteries, controller, joystick) and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
Yes
The device is a power wheelchair designed to assist individuals with various medical conditions by providing mobility and the ability to change positions, which directly addresses a health-related need.
No
The device description clearly states it is a power wheelchair, a mobility aid that changes a user's position, and it does not mention any function for diagnosing medical conditions.
No
The device description clearly outlines a physical power wheelchair with multiple hardware components including a base, wheels, batteries, motors, and a controller. It is not solely software.
Based on the provided information, the LEVO comfort II stand-up power wheelchair 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, or tissue) to provide information about a person's health.
- LEVO comfort II Function: The LEVO comfort II is a power wheelchair designed to provide mobility and change a person's position from sitting to standing. It is a mechanical and electrical device used externally on the body.
- Intended Use: The intended use clearly describes a device for mobility and positional changes, not for analyzing biological samples.
- Device Description: The description details the mechanical and electrical components of a wheelchair, not equipment for laboratory analysis.
Therefore, the LEVO comfort II falls under the category of a medical device, but specifically a mobility aid, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LEVO comfort II stand-up power wheelchair is a product which changes people's position from sitting to Standing and Standing to sitting but also any position in between. The product provides indoor and outdoor mobility.
The LEVO comfort II stand-up power wheelchair may be of interest for any individuals who needs a power wheelchair and can not stand up on their own such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc..
Product codes
IPL
Device Description
The LEVO comfort II power wheelchair is centre wheel driven, battery powered, motor driven and is controlled by the PG Drives Technology's power wheelchair controller "VSI" The Joystick is integrated in the Controller.
The wheelchair is powered by: two 12V/26Ah, two 12V/40Ah or four 12V/26Ah batteries with a theoretical driving range of 14km (26Ah), 20km (40Ah) or 28km (56Ah) on the fully charged batteries.
The wheelchair consists of the following basic sub-sections:
- Base with two direct-drive units with integrated parking brakes, two 12V/26Ah, two 12V/40Ah or four 12V/26Ah, two 14"x2%" rear wheels and two 8"x2" front wheels.
- PG Drives Technology's power wheelchair controller . "VSI"
- Seating System including stand-up mechanisms and ● actuator.
The base is of welded steel construction and includes the base frame, front castor wheels, rear driving wheels with drive unit (motor/gear/brakes) and batteries. The motor Controller is mounted to the left or right armrest, depending on the user's needs.
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 LEVO comfort II was basically developed on experience of the LEVO mobil LCM. However being able to provide additional outdoor mobility as well as further improvements in the geometric for an excellent biomechanical response to the user's body. The only modifications are simply colour and design changes. So the LEVO comfort II has in substantial the same technological characteristics and the same safety and effectiveness as the predicate device(s) and the minor changes declared in the Submission do not raise new questions of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 963817, K 031289
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KOS1387
JUN 1 0 2005
510(k) Summary of Safety and Effectiveness
LEVO comfort II
| Submitter: | LEVO AG
P.O. Box 1272
Anglikerstrasse 20
CH-5610 Wohlen, Switzerland |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone: | +41 56-6184411 |
| Fax: | +41 56-6184410 |
| Contact Person: | Mr. Markus Burger, Head of R&D
Mr. Thomas Raeber, Managing Director |
| E-Mail-Address: | m.burger@levo.ch
raeber@levo.ch |
| Device Name: | LEVO comfort II |
| Classification Name: | Electrical Power Wheelchair, Stand-up |
| Identification of
Predicate Devices: | LEVO mobil LCM (K 963817)
Quickie Freestyle (K 031289) |
| Intended Use: | The LEVO comfort II stand-up power wheelchair is a product
which changes people's position from sitting to Standing and
Standing to sitting but also any position in between. The
product provides indoor and outdoor mobility. |
| Description of
the Device: | The LEVO comfort II power wheelchair is centre wheel
driven, battery powered, motor driven and is controlled by the
PG Drives Technology's power wheelchair controller "VSI"
The Joystick is integrated in the Controller.
The wheelchair is powered by: two 12V/26Ah, two
12V/40Ah or four 12V/26Ah batteries with a theoretical
driving range of 14km (26Ah), 20km (40Ah) or 28km
(56Ah) on the fully charged batteries. |
1
KOSIJ87
The wheelchair consists of the following basic sub-sections:
- Base with two direct-drive units with integrated parking brakes, two 12V/26Ah, two 12V/40Ah or four 12V/26Ah, two 14"x2%" rear wheels and two 8"x2" front wheels.
- PG Drives Technology's power wheelchair controller . "VSI"
- Seating System including stand-up mechanisms and ● actuator.
The base is of welded steel construction and includes the base frame, front castor wheels, rear driving wheels with drive unit (motor/gear/brakes) and batteries. The motor Controller is mounted to the left or right armrest, depending on the user's needs.
Safety and Effectiveness:
The LEVO comfort II was basically developed on experience of the LEVO mobil LCM. However being able to provide additional outdoor mobility as well as further improvements in the geometric for an excellent biomechanical response to the user's body. The only modifications are simply colour and design changes. So the LEVO comfort II has in substantial the same technological characteristics and the same safety and effectiveness as the predicate device(s) and the minor changes declared in the Submission do not raise new questions of safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circle around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 2005
Levo AG C/o Mr. Stefan Priess TUV America, Inc. 1775 Old Highway 8 New Brighton, Minnesota 55112
Re: K051387
Trade/Device Name: LEVO comfort II Regulation Number: 21 CFR 890.3900 Regulation Name: Standup Wheelchair Regulatory Class: II Product Code: IPL Dated: May 25, 2005 Received: May 27, 2005
Dear Mr. Preiss:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 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 that 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 comply 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.
3
Page 2 - Mr. Stefan Priess
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/industry/support/index.html
Sincerely yours,
Miriam C. Provost, Ph.D.
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): not known
Device Name: LEVO comfort II
The LEVO comfort II stand-up power wheelchair may be of interest for Indications for Use: any individuals who needs a power wheelchair and can not stand up on their own such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc..
Intended use: The LEVO comfort II stand-up power wheelchair is a product which changes people's position from sitting to Standing to sitting but also any position in between. The product provides indoor and outdoor mobility.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _XX (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number_K051387