(178 days)
Not Found
Not Found
No
The summary contains no mention of AI, ML, or related concepts, and the device description is not available to infer such capabilities.
No
The device provides mobility to persons restricted to a sitting position, which is a supportive function rather than directly treating or curing a medical condition.
No
The intended use states the device provides mobility to persons restricted to a sitting position, which is not a diagnostic function.
Unknown
The provided text only includes the intended use and lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.
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 to persons restricted to a sitting position." This describes a device used on a patient for a physical function (mobility), not a device used with biological samples (like blood, urine, or tissue) to diagnose or monitor a medical condition.
- Lack of IVD Indicators: The description lacks any mention of:
- Analyzing biological samples.
- Diagnosing, monitoring, or screening for diseases or conditions.
- Using reagents or other materials typically associated with IVD testing.
The description strongly suggests a mobility aid, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Product codes
ITI
Device Description
Not Found
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
Not Found
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is written around the border of the circle.
FEB 0 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
The Lin Prosthetic & Orthopaedic, Inc. Ke-Min Jen, Ph.D. c/o ROC Chinese-European Industrial Research Society No. 58. Fu-Chiun St. Hsin Chu City, China (Taiwan) 300
Re: K022696
Trade/Device Name: The Lin Powered Wheelchair, Model MDG-201 Regulation Number: 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: November 26, 2002 Received: December 2, 2002
Dear Dr. Jen:
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.
1
Page 2 - Dr. Ke-Min Jen
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 premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Mark N. Mikkelsen
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
Ericlosure
2
Page_____of__1_
510 (K) NUMBER ( IF KNOW ): _ TBA TEH LIN POWERED WHEELCHAIR MDG-201 DEVICE NAME:
INDICATIONS FOR USE:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE )
Concurrence of CDRH, office of Device Evaluation (ODE )
Prescription Use ✓ OR
( Per 21 CFR 801.109 )
Division Sign Off
f General. Restorative and Neurological Devices
510(k) Number --
Over - The - Counter - Use____________________________________________________________________________________________________________________________________________________
( Optional Format 1-2-96 )