(31 days)
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Not Found
No
The summary describes a manual wheelchair and contains no mention of AI, ML, or related technologies.
No
The device provides mobility support, which assists with daily living and is rehabilitative, but it does not directly treat or cure a disease or condition in a therapeutic way.
No
The "Intended Use / Indications for Use" states the device is for providing mobility, which is a therapeutic or assistive function, not a diagnostic one.
No
The device description explicitly states "MANUAL WHEELCHAIR," which is a hardware device.
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 is a physical function, not a diagnostic test performed on samples from the human body.
- Device Description: It's described as a "MANUAL WHEELCHAIR," which is a mobility aid.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
IVD devices are specifically designed to perform tests on biological samples to provide information about a person's health status. This device's function is purely mechanical and related to mobility.
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
IOR
Device Description
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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)
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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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§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle-like symbol with three overlapping profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
SEP 1 3 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Forever Young Enterprise Company, LTD. c/o Ke-Min Jen, Ph.D. Roc Chinese-European Industrial Research Society No. 58 Fu-Chiun Street Hsin-Chu City China (Taiwan)
Re: K022699
Trade/Device Name: Transfer Companion HR 3000 Manual Wheelchair Regulation Number: 890.3850 Regulation Name: Wheelchair, mechanical Regulatory Class: I Product Code: IOR Dated: July 30, 2002 Received: August 13, 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 and additionally 21 CFR Part 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" (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.
Sincerely yours,
Mark N. Mellema
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
2
Page 1 of
510 (K) NUMBER ( IF KNOW ): ) TBA
DE VICE NAME : TRANSFER COMPANION HR3000 MANUAL WHEELCHAIR
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)
OR
Prescription Use ________________
( Per 21 CFR 801.109 )
Over - The -- Counter -- Use_ -
( Optional Format 1-2-96 )
Mark-N Millican
and Neurological Dev 510(k) Number -