(14 days)
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No
The summary describes a manual, attendant-controlled wheelchair with a modular design. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No
The device is a wheelchair, which provides mobility for individuals with physical challenges. While it assists with daily living and can improve quality of life, it does not directly treat or cure a disease or condition in a therapeutic sense.
No
The device is described as a wheelchair intended to provide mobility for physically challenged individuals, not to diagnose medical conditions.
No
The device description clearly describes a physical wheelchair with a chassis, frame, and seating, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a wheelchair designed to provide mobility and support for individuals with physical disabilities. This is a medical device, but not one used for in vitro diagnostic purposes.
- Device Description: The description focuses on the physical construction, materials, and features of a wheelchair. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as reagents, calibrators, controls, or methods for detecting or measuring substances in biological samples.
In summary, the Chunc pediatric attendant controlled wheelchair is a mobility aid, not a device used for diagnosing diseases or conditions through the examination of samples outside the body.
No
The provided FDA clearance letter does not contain any information or mention of the device being authorized under a Predetermined Change Control Plan (PCCP). PCCP authorization is explicitly stated in the clearance letter when applicable, and this document lacks such mention.
Intended Use / Indications for Use
Chunc pediatic attendant controlled wheelchair is intended for clients with moderate to specialists.
The controlled by the for the last controlled needs first and foremost. Chunc pediatic attendant controlled wheeledall 15 michood attendents needs first and foremost.
Chunc manual wheelchairs empower physically challenged persons by providing a means of ten and and contract and annonemant conditions swch as: Chunc manual whicheman's chiponery and permanent conditions such as:
| Arthritis | Tetraplegic | Multiple Sclerosis |
|---|---|---|
| Amputee | Quadriplegic | Polio |
| Paraplegic | Spina Bifida | Cerebral Palsy |
| Muscular Dystrophy | and any other immobilizing or debilitating condition |
Product codes
IOR
Device Description
The modular design of the wheelchair chassis, frame and seating allows for flexibility and ease of The modular design of the wheelchard and social needs. This coupled with material choice and the frequent use of like parts across the when associated us to keep costs at a numming the frequent use of like parts actoss to be easily identifies a for any increase tunctions using unified adjustments with color coding which are also simple to see and maintain. By moving away from the cumbersome welded steel structures of conventional wheelchairs we have been away from the cumbersome welcen steer surverling of envired to envire the wheelchair is lightweight and therefore comfortable to use. Chunc is carrently manifactured and marketed the lightweight and therefore comical by the National Health Service (NHS) and has the relevant CES marking. Chunc also provides the ability for Bus Transportation and notest that meet the marking. Chunc also provides the ability to: Dos Transportation and occupants (WTORS) that meet the requirements of SAE J2249
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP = 8 2004
Mr. Steve Gibson Specmat Technologies, Inc. 215 Dunavant Drive Rockford, Tennessee 37853
Re: K042304
K04250+
Trade/Device Name: Chunc Junior Model# Sm 242, Chunc Adapt Model # Sm 251 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: August 24, 2004 Received: August 25, 2004
Dear Mr. Gibson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications forchered above and have sure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to conimetee prior to may 20, 2017 3)
devices that have been reclassified in accordance with the provisions of the Federal Food, DNA A de rices may been receases at require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, merelere, maxis 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 may be subject to back academans, 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 that I Dr has intatutes and regulations administered by other Federal agencies. You must or any I outher 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 Orth 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 – Mr. Steve Gibson
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in yourse FDA finding of substantial equivalence of your device to a legally premailed predicated with 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 If you desire specific as not as (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 other general mionnation of Jour Copsumer 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. Williams
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
510(k) Number (if known): K042304
Device Name: Chunc Junior Model# Sm 242, Chunc Adapt Model # Sm 251
Indications For Use:
Chunc pediatic attendant controlled wheelchair is intended for clients with moderate to specialists.
The controlled by the for the last controlled needs first and foremost. Chunc pediatic attendant controlled wheeledall 15 michood attendents needs first and foremost.
Chunc manual wheelchairs empower physically challenged persons by providing a means of
ten and and contract and annonemant conditions swch as: Chunc manual whicheman's chiponery and permanent conditions such as:
| Arthritis | Tetraplegic | Multiple Sclerosis |
|---|---|---|
| Amputee | Quadriplegic | Polio |
| Paraplegic | Spina Bifida | Cerebral Palsy |
| Muscular Dystrophy | and any other immobilizing or debilitating condition |
The modular design of the wheelchair chassis, frame and seating allows for flexibility and ease of The modular design of the wheelchard and social needs. This coupled with material choice and the frequent use of like parts across the when associated us to keep costs at a numming the frequent use of like parts actoss to be easily identifies a for any increase tunctions using unified adjustments with color coding which are also simple to see and maintain. By moving away from the cumbersome welded steel structures of conventional wheelchairs we have been away from the cumbersome welcen steer surverling of envired to envire the wheelchair is lightweight and therefore comfortable to use. Chunc is carrently manifactured and marketed the lightweight and therefore comical by the National Health Service (NHS) and has the relevant CES marking. Chunc also provides the ability for Bus Transportation and notest that meet the marking. Chunc also provides the ability to: Dos Transportation and occupants (WTORS) that meet the requirements of SAE J2249
| Prescription Use | |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Millerson
Division of General, Restorative, and Neurological Devices
Page 1 of _
10(k) Number K042304
510(k) Number.