(209 days)
Not Found
Not Found
No
The summary describes a mechanical device for changing patient position and providing mobility, with no mention of AI, ML, image processing, or data-driven performance metrics.
No.
The device is described as a standing wheelchair that changes body positions and provides mobility, which are supportive functions and not explicitly therapeutic. While it benefits individuals with various medical conditions by providing mobility and position changes, its primary function is not to treat or cure a disease or condition.
No
The device description indicates it is a mobility aid (a wheelchair that changes positions), not a device used to identify or analyze a disease or medical condition.
No
The description clearly indicates a physical product that changes position and provides mobility, implying a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device's purpose is to assist with mobility and position changes for individuals with various physical limitations. This is a therapeutic or assistive device, not a diagnostic one.
- Device Description: The description focuses on the mechanical functions of the device (changing position, providing mobility). It does not mention any components or processes related to analyzing biological samples or providing diagnostic information.
- Lack of IVD-related information: 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 biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
In summary, the device described is a mobility and positioning aid, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The device is a product which changes people 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 standing 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..
Product codes
IPL
Device Description
The device is a product which changes people 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.
Mentions image processing
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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)
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 2003
Comfort Orthopedic Company, LTD Eric H.C. Lee No. 120 Nan Shiang Tsuen Shoei Shang Shiang Chia-Yi, Taiwan China
Re: K031618
Trade/Device Name: COMFORT Standing Wheelchair, Hero 2 Regulation Number: 890.3900 Regulation Name: Wheelchair, standup Regulatory Class: II Product Codes: IPL Dated: November 5, 2003 Received: November 10, 2003
Dear: Mr. Lec:
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 he 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.
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Page 2 - Mr. Lee
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). 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,
Mark A. Millman
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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Page_1_of_1_
المدرب
510 (K) NUMBER ( IF KNOWN ): ): TBA DEVICE NAME: COMFORT Standing Wheelchair, HERO 2
Intended Use:
The device is a product which changes people 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 standing 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..
( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
Concurrence of CDRH, office of Device Evaluation (ODE )
| Prescription Use | OR | Over -- The -- Counter -- Use ✓ |
|---|---|---|
| ( Per 21 CFR 801.109 ) | (Optional Format 1-2-96 ) |
for Mark N. Millan
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| (K) Number | K031618 |
|---|---|
| ------------ | --------- |
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