(456 days)
Not Found
Not Found
No
The description focuses on the mechanical and electrical function of a stand-up wheelchair and does not mention any AI or ML components.
No.
The device's primary function is to assist with mobility and changing position (seating to standing and vice versa) for individuals with various physical limitations. While it mentions "daily therapy individually" as a benefit, its core purpose is not to treat or cure a medical condition but rather to provide functional assistance and improve quality of life.
No
Explanation: The device is an electrical power wheelchair designed to assist users with mobility and standing. Its stated purpose does not involve detecting, diagnosing, or monitoring medical conditions.
No
The device description clearly states it is an "electrical stand-up mechanism integrated in an electrical power wheelchair," indicating it is a hardware device with an electrical component, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to change a person's position from seating to standing and vice versa. This is a physical function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is an electrical power wheelchair with a stand-up mechanism. This describes a mobility aid, not a diagnostic instrument.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly intended to assist individuals with mobility limitations by providing a means to stand up. This falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LEVO stand-up electrical power wheelchair is a product which changes peoples position from seating to standing and standing to seating.
Target population:
• For whole those who needs an electrical power 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 ..
The LEVO mobil LCM 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 stand-up mechanism is integrated in an electrical power wheelchair which allows the user to stand up easily when and where ever he wants to.
Material:
• Main frame: Colour painted steel.
• Major stressed parts: Reinforced brass casting.
• Upholstery: Flame impeded.
• Batteries: 2 x 12 V/25 Ah (serial connected) Gel, sealed lead acid batteries or 2 x 2 x 12 V/25 Ah for higher range (50 Ah).
• Stand-up motor: Bosch-24 V DC, 3.5 A, 84Ah (CE marked).
• Driving motors: Schmid 24 V DC, 8 A, 0.16 KW with 12 V brakes
Electronic: Penny & Giles PG8 Controller
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
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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)
Not Found
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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas Raeber ·LEVO AG Dottikon Bleicheweq 5 CH-5605 Dottikon Schweiz, Switerland
DEC 23 1997
Re: K963817 LEVO Mobil LCM Requlatory Class: II Product Code: IPL Dated: October 13, 1997 Received: October 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, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಗ್ಗ 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 requlatory action. In addition, FDA may publish further announcements Please note: concerning your device in the Federal Register. 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
Paqe 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 diaqnostic 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 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,
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
K963817
.k) Number (if known):
LEVO mobil LCM
Device Name:
Indications For Use:
- . The LEVO stand-up electrical power wheelchair is a product which changes peoples position from seating to standing and standing to seating.
Target population:
- · For whole those who needs an electrical power 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 stand-up mechanism is integrated in an electrical power wheelchair which allows the user to stand up easily when and where ever he wants to.
| Material: | |
|---|---|
| • Main frame: | Colour painted steel. |
| • Major stressed parts: | Reinforced brass casting. |
| • Upholstery: | Flame impeded. |
| • Batteries: | 2 x 12 V/25 Ah (serial connected) Gel, sealed lead acid batteries |
| or 2 x 2 x 12 V/25 Ah for higher range (50 Ah). | |
| • Stand-up motor: | Bosch-24 V DC, 3.5 A, 84Ah (CE marked). |
| • Driving motors: | Schmid 24 V DC, 8 A, 0.16 KW with 12 V brakes |
| Electronic: | Penny & Giles PG8 Controller |
Performance:
- The LEVO mobil LCM 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.