(68 days)
Not Found
Not Found
No
The description focuses on the mechanical and electrical components of a stand-up wheelchair and does not mention any AI or ML capabilities.
No.
The device is described as a stand-up wheelchair that assists users with mobility impairments to stand, which is primarily a rehabilitative or assistive function for daily living, rather than directly treating a disease or condition. The mention of "daily therapy individually" suggests it supports therapy, but is not a therapeutic device itself.
No
The device, a stand-up wheelchair, is described as a product that changes position and allows users to stand up. Its indications for use are for individuals with conditions like spinal cord injury or cerebral palsy who need a wheelchair and cannot stand on their own. This functionality relates to mobility and assistance, not to diagnosing medical conditions.
No
The device description clearly outlines hardware components such as a frame, battery, and motor, indicating it is a physical medical device with an integrated electrical power support mechanism, not a software-only device.
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 and the ability to change position from seating to standing for individuals who cannot stand on their own. This is a physical function, not a diagnostic test performed on samples from the human body.
- Device Description: The device is a wheelchair with an integrated electrical stand-up mechanism. It's a mechanical and electrical device for physical support and movement.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions through in vitro methods, or providing diagnostic information.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
- The LEVO stand-up wheelchair is a product which changes position from seating to standing and . standing to seating.
Target population:
- · For whole those who need a wheelchair and can not stand on their on feet such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc..
Performance:
- The LEVO compact easy LCE allows the user to stand up easily when and where ever he wants to. Whether to reach things without help of others, whether take part in discussions standing up and show influence, whether just to do daily therapy individually.
Product codes
IPL
Device Description
- · An electrical power suported stand-up mechanism is integrated in a manual driven wheelchair which allows the user to stand up easily when and where ever he wants to.
Material:
- · Main frame: Colour painted aluminium.
- · Major stressed parts: Reinforced brass casting.
- Uphoistery: . Flame impeded.
- · Batterv:
- Stand-up motor: .
- 2 Gel, sealed lead acid battery (12V/2.9Ah in series=24V/2.9Ah) Linak Power Drive LA 28.405-150-24-001 24 VDC, 2500N
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): 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.
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 23 1997
Mr. Thomas Raeber LEVO AG Dottikon Bleicheweq 5 CH-5605 Dottikon Schweiz, Switerland
K973951 Re: LEVO Compact-Easy LCE Requlatory Class: II Product Code: IPL Dated: October 9, 1997 October 16, 1997 Received:
Dear Mr. Raeber:
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. ਸ 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 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 requlation 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 regulations.
1
Page 2 - Mr. Thomas Raeber
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 Activery 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.tml" a
Sincerely yours,
years,
Lily White
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
2
510(k) Number (if known): . .
Device Name:
:
LEVO compact-easy LCE
Indications For Use:
- The LEVO stand-up wheelchair is a product which changes position from seating to standing and . standing to seating.
Target population:
- · For whole those who need a wheelchair and can not stand on their on feet such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc..
Design:
- · An electrical power suported stand-up mechanism is integrated in a manual driven wheelchair which allows the user to stand up easily when and where ever he wants to.
Material:
- · Main frame: Colour painted aluminium.
- · Major stressed parts: Reinforced brass casting.
- Uphoistery: . Flame impeded.
- · Batterv:
- Stand-up motor: .
2 Gel, sealed lead acid battery (12V/2.9Ah in series=24V/2.9Ah) Linak Power Drive LA 28.405-150-24-001 24 VDC, 2500N
Performance:
- The LEVO compact easy LCE allows the user to stand up easily when and where ever he wants to. Whether to reach things without help of others, whether take part in discussions standing up and show influence, whether just to do daily therapy individually.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Alan Watts
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)