(12 days)
K 963817
Not Found
No
The description focuses on the mechanical and electrical components of a power wheelchair and its control system, with no mention of AI or ML technologies.
No
Therapeutic devices are used to treat diseases or conditions, whereas this device provides mobility and positional changes for individuals who cannot stand or move independently.
No
The device description clearly states that the LEVO combi powered wheelchair is a mobility device designed to change user positions and provide indoor and outdoor mobility. Its components and functions (e.g., motor-driven, joystick controlled, batteries, wheels) are all related to physical movement and positioning, not to identifying or analyzing medical conditions or biological processes.
No
The device description clearly outlines a physical, hardware-based medical device (a powered wheelchair) with mechanical and electrical components, not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The LEVO combi stand-up electrical power wheelchair is a mobility device designed to assist individuals with physical limitations in moving and changing positions. It operates externally to the body and does not analyze biological samples.
- Intended Use: The intended use clearly describes providing mobility and position changes for individuals who cannot stand on their own. This is a functional aid, not a diagnostic tool.
The description of the device, its components, and its intended use all point to it being a medical device for mobility and support, not an IVD.
N/A
Intended Use / Indications for Use
The LEVO combi stand-up electrical power wheelchair is a product which changes peoples position not only from sitting to standing and standing to sitting but also reclines and lifts the seat and back position. The product provides indoor and outdoor mobility.
Product codes
IPL
Device Description
The LEVO combi powered wheelchair is centre wheel driven, battery powered, motor driven and is controlled by the Penny & Giles compact power wheelchair controller Pilot+. The joystick is integrated in the controller.
The wheelchair is powered by two 12V55Ah batteries with a theoretical driving range of 35km 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 12V55Ah batteries, two 14"x2¾" centre wheels, two 8"x2" front wheels, and one 5½"x1½" rear wheel with suspension.
- Penny & Giles power electronics Pilot+.
- Seating system including mechanisms for all possible. positions, stand-up actuator and optional lift and/or backrest actuator.
The base is of welded steel construction and includes the base frame, front castor wheels, centre driving wheels with drive unit (motor/gear/brakes), batteries and pivoting rear castor. 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
LEVO mobil LCM (K 963817)
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
510(k) Summary of Safety and Effectiveness
LEVO combi
APR - 2 2003
| Submitter: | LEVO AG
P.O. Box 1272
Anglikerstrasse 20
CH-5610 Wohlen, Switzerland |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone:
Fax: | +41 56-618 44 11
+41 56-618 44 10 |
| Contact Person: | Mr. Thomas Raeber, Managing Director or
Dr. Kurt H. Fischer, CEO |
| E-Mail-Address: | raeber@levo.ch
fischer@levo.ch |
| Device Name: | LEVO combi |
| Classification Name: | Electrical Power Wheelchair, Stand-up |
| Identification of
Predicate Devices: | LEVO mobil LCM (K 963817) |
| Indtended Use: | The LEVO combi stand-up electrical power wheelchair
is a product which changes peoples position not only
from sitting to standing and standing to sitting but also
reclines and lifts the seat and back position. The product
provides indoor and outdoor mobility. |
| Description of
the Device: | The LEVO combi powered wheelchair is centre wheel
driven, battery powered, motor driven and is controlled
by the Penny & Giles compact power wheelchair
controller Pilot+. The joystick is integrated in the
controller.
The wheelchair is powered by two 12V55Ah batteries
with a theoretical driving range of 35km on the fully
charged batteries.
The wheelchair consists of the following basic sub-
sections: |
1
- Base with two direct-drive units with integrated . parking brakes, two 12V55Ah batteries, two 14"x2¾" centre wheels, two 8"x2" front wheels, and one 5½"x1½" rear wheel with suspension.
- Penny & Giles power electronics Pilot+ .
- Seating system including mechanisms for all possible . positions, stand-up actuator and optional lift and/or backrest actuator.
The base is of welded steel construction and includes the base frame, front castor wheels, centre driving wheels with drive unit (motor/gear/brakes), batteries and pivoting rear castor. The motor controller is mounted to the left or right armrest, depending on the user's needs,
Substantial Equivalence:
The LEVO combi is substantial equivalent with respect to intended use, and materials to the predicate device. The key changes are rear suspension, outdoor mobility. the use of the Pilot+ controller from Penny & Giles instead of the PG8 controller from Penny & Giles, as well as additional possibilities to change positions (reclining up to lying, relax position).
Safety and Effectiveness:
LEVO combi was basically developed The 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, there are a few additional functions and adjustments integrated. The rest of it is simply colour and design changes. So the LEVO combi 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 is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR = 2 2003
LEVO AG c/o Mr. Stefan Preiss TUV America, Inc. 1775 Old Highway 8 New Brighton, MN 55112
Re: K030893
Trade/Device Name: LEVO combi Regulation Number: 21 CFR 890.3900 Regulation Name: Standup wheelchair Regulatory Class: II Product Code: IPL Dated: March 21, 2003 Received: March 21, 2003
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 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 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premar:et 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,
sincerely yours,
Mark N. Mulkerson
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
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Statement of Indication for Use
Device Name: LEVO combi
Intended Use:
The LEVO combi stand-up electrical power wheelchair is a product which changes peoples position not only from sitting to standing and standing to sitting but also reclines and lifts the seat and back position. The product provides indoor and outdoor mobility.
Target Population:
For all individuals who need a power wheelchair with the possibility to change positions and who can not stand on their feet themselves such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc..
Mark N. Milken
Division Sign-Of Division of Genera storative and Neurological L . ces K 030893
510(k) Number_
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