(44 days)
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Not Found
No
The description focuses on a mechanical stand-up mechanism and does not mention any AI or ML components.
Yes
The device is described as allowing "daily therapy individually" and is indicated for conditions like "spinal cord injury, spina bifida, cerebral palsy," which suggests a therapeutic purpose beyond just mobility.
No
The LEVO stand-up wheelchair is a mobility device designed to change user position from seating to standing. Its purpose is to assist individuals with various conditions causing mobility issues to stand easily, reach objects, and participate in social interactions. It does not collect or analyze any physiological data to diagnose a condition or disease.
No
The device description clearly outlines a physical wheelchair with a manual stand-up mechanism, made of materials like aluminum and brass. This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The LEVO stand-up wheelchair is a mechanical device designed to assist individuals with mobility impairments in changing positions from sitting to standing and vice versa. It is a physical aid for mobility and therapy.
- Lack of Specimen Analysis: The description does not mention any analysis of biological specimens. The device's function is purely mechanical and related to physical support and movement.
Therefore, based on the provided information, the LEVO stand-up wheelchair falls under the category of a mobility aid or assistive device, not an In Vitro Diagnostic.
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..
Product codes
IPL
Device Description
Design:
- A manual 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.
- Upholstery: Flame impeded.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance:
- The LEVO active-easy LAE 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community and support.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas Raeber Managing Director Levo AG Dottikon Bleicheweg 5, CH-5605 Dottikon Schweiz, Switzerland
JUL - 3 1997
K971873 Re: LEVO active-easy LAE Requlatory Class: II Product Code: IPL Dated: May 12, 1997 Received: May 20, 1997
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, Druq, 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 Requlations, Title 21, Parts 800 to 895. A 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 Reqister. 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 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 Milkerner
Celia M. Witten, Ph.D., M.D. Director
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
2
Page of
. ﺍ
K971873
LEVO active-easy LAE
510(k) Number (if known): __________
Device Name:__________________________________________________________________________________________________________________________________________________________________
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:
- · A manual 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:
- Colour painted aluminium. · Main frame: · Major stressed parts: Reinforced brass casting.
- Upholstery: Flame impeded. .
Performance:
- · The LEVO active-easy LAE 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)
| Mark N Milkers | |
|---|---|
| for | (Division Sign-Off) |
| Division of General Restorative Devices | |
| 510(k) Number | K971873 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use ✓ (Optional Format 1-2-96) |
|---|---|---|
| --------------------------------------- | ---- | --------------------------------------------------------------------------------------------------------------- |