(35 days)
Not Found
No
The description focuses on standard power wheelchair components and functionality, with no mention of AI or ML.
No
The device is a power standup wheelchair designed for mobility and changing positions, which is not typically classified as a therapeutic device. It is primarily a mobility aid.
No
The device description clearly states it is a power standup wheelchair used for mobility and changing positions, which are functional, not diagnostic, purposes.
No
The device description explicitly states it consists of hardware components such as a welded steel frame, transaxle motor drive system, braking system, electronic motor controller, and batteries.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to change a person's position and provide mobility. This is a physical function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a mechanical and electrical device for mobility, not a reagent, instrument, or system intended for use in the examination of specimens derived from the human body.
- Lack of IVD Characteristics: The document 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 those samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
This device is clearly a mobility aid, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LLOYD LINDEN EO4 power standup wheelchair is a product which changes people's position from sitting to standing and standing to sitting but also any position in between. It provides indoor and outdoor mobility.
Product codes (comma separated list FDA assigned to the subject device)
IPL
Device Description
The LLOYD LINDEN EO4 power standup wheelchair is an indoor/outdoor power stand up wheelchair that is battery operated. The design of this wheelchair is basically similar to other power stand up wheelchairs that are already on the market. It consists primarily of a welded steel frame, transaxle motor drive system, braking system and electronic motor controller and is powered by two 12 volt DC batteries, and utilize a charger.
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.
Lifestand LSC (K061726)
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
AUG - 3 2007
Lloyd Linden INC.
No. 10-2, Nei-Chung-Fu, Kan-Chiao Village, Wanli, Taipei County, Taiwan FAX: + 886-2-2492-3113 TEL: +886- 2-2492-5025
510(k) Summary
Device
Trade name: LLOYD LINDEN EO4 power standup wheelchair Common name: Standup wheelchair Classification name: Standup wheelchair Medical specialty (Panel): Physical Medicine Device Regulation number: 890.3900 Product Code: IPL Classification: Class II Predicate devices
Lifestand LSC (K061726) / Lifestand
Intend use of device
LLOYD LINDEN EO4 power standup wheelchair is a product which changes people's position from sitting to standing and standing to sitting but also any position in between. It provides indoor and outdoor mobility.
Device description:
The LLOYD LINDEN EO4 power standup wheelchair is an indoor/outdoor power stand up wheelchair that is battery operated. The design of this wheelchair is basically similar to other power stand up wheelchairs that are already on the market. It consists primarily of a welded steel frame, transaxle motor drive system, braking system and electronic motor controller and is powered by two 12 volt DC batteries, and utilize a charger.
Substantial equivalence:
The LLOYD LINDEN EO4 power standup wheelchair is substantially equivalent to the Lifestand LSC (K061726) manufactured by Lifestand.
There are minor differences in performance specifications of the power standup wheelchairs, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness. Therefore, LLOYD LINDEN INC. believes that the LLOYD LINDEN EO4 power standup wheelchair is substantially equivalent to legally marketed devices currently in commercial distribution.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" surrounding the top half of the circle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 3 2007
Lloyd Linden, Inc. % Junnata Chang No. 10-2, Nei-Chung-Fu Kan-Chia Village Wanli, Taipei County Taiwan
Re: K071761
Trade/Device Name: Lloyd Linden E04 Power Standup Wheelchair Regulation Number: 21 CFR 890.3900 Regulation Name: Standup wheelchair Regulatory Class: Class II Product Code: IPL Dated: June 20, 2007 Received: June 29, 2007
Dear Junnata Chang:
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.
2
Page 2 - Junnata Chang
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely you Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
3
- Device descriptive information
3.1 Statement of indication for use
Statement of Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: LLOYD LINDEN EO4 power standup wheelchair
Indications for Use:
The LLOYD LINDEN EO4 power standup wheelchair is a product which changes people's position from sitting to standing and standing to sitting but also any position in between. It provides indoor and outdoor mobility.
| Prescription Use | Over-The-Counter Use | X | |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | AND/OR | (Part 21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number 1107761
(Posted November 13, 2003)
(Posted November 13, 2003)
3-1